Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-01-24 @ 11:34 AM
Study NCT ID:
NCT02486718
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-10
First Post:
2015-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594389', 'term': 'atezolizumab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000077235', 'term': 'Vinorelbine'}, {'id': 'D000077143', 'term': 'Docetaxel'}, {'id': 'D000093542', 'term': 'Gemcitabine'}, {'id': 'D000068437', 'term': 'Pemetrexed'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D014748', 'term': 'Vinca Alkaloids'}, {'id': 'D046948', 'term': 'Secologanin Tryptamine Alkaloids'}, {'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}, {'id': 'D043823', 'term': 'Taxoids'}, {'id': 'D043822', 'term': 'Cyclodecanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004224', 'term': 'Diterpenes'}, {'id': 'D013729', 'term': 'Terpenes'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D005971', 'term': 'Glutamates'}, {'id': 'D024342', 'term': 'Amino Acids, Acidic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000600', 'term': 'Amino Acids, Dicarboxylic'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': 'The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor’s intellectual property rights.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 95 months', 'description': 'Enrolled safety-evaluable population included patients in enrollment phase \\& received at least 1 dose of chemo. Randomized safety-evaluable population included randomized patients who received at least 1 dose of atezo \\& randomized patients who were randomized to control arm \\& did not receive any dose of atezo but had at least 1 post-baseline safety assessment, regardless of their assigned treatment at randomization. All-cause mortality reported for deaths that occurred during study based on ITT.', 'eventGroups': [{'id': 'EG000', 'title': 'Enrollment Phase', 'description': "All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \\[non-squamous cell NSCLC only\\] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred.", 'otherNumAtRisk': 1269, 'deathsNumAtRisk': 1269, 'otherNumAffected': 1153, 'seriousNumAtRisk': 1269, 'deathsNumAffected': 19, 'seriousNumAffected': 259}, {'id': 'EG001', 'title': 'Best Supportive Care (BSC)', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.', 'otherNumAtRisk': 495, 'deathsNumAtRisk': 495, 'otherNumAffected': 227, 'seriousNumAtRisk': 495, 'deathsNumAffected': 155, 'seriousNumAffected': 42}, {'id': 'EG002', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.', 'otherNumAtRisk': 495, 'deathsNumAtRisk': 495, 'otherNumAffected': 358, 'seriousNumAtRisk': 495, 'deathsNumAffected': 154, 'seriousNumAffected': 88}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 422, 'numAffected': 357}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 30, 'numAffected': 30}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 47, 'numAffected': 37}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 36, 'numAffected': 33}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Hypothyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 61, 'numAffected': 54}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 226, 'numAffected': 181}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 54, 'numAffected': 36}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 1032, 'numAffected': 660}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 44, 'numAffected': 31}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 301, 'numAffected': 234}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 15, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 45, 'numAffected': 37}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 309, 'numAffected': 269}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 41, 'numAffected': 33}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 86, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 14, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 67, 'numAffected': 60}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 26, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 65, 'numAffected': 50}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 44, 'numAffected': 33}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 33, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 43, 'numAffected': 37}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 57, 'numAffected': 52}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 17, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 71, 'numAffected': 54}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 47, 'numAffected': 43}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 67, 'numAffected': 54}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Blood creatinine increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 113, 'numAffected': 85}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 36, 'numAffected': 29}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 41, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 35, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 65, 'numAffected': 52}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 90, 'numAffected': 77}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 22, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 39, 'numAffected': 28}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 101, 'numAffected': 93}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 55, 'numAffected': 46}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 84, 'numAffected': 66}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 64, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 33, 'numAffected': 32}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 35, 'numAffected': 31}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 26, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 55, 'numAffected': 51}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 58, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 7, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 58, 'numAffected': 48}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 128, 'numAffected': 84}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 10, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 568, 'numAffected': 338}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 33, 'numAffected': 21}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 94, 'numAffected': 67}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 9, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 11, 'numAffected': 9}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 75, 'numAffected': 69}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 389, 'numAffected': 317}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 27, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 361, 'numAffected': 248}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 27, 'numAffected': 20}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 94, 'numAffected': 66}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 367, 'numAffected': 187}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 108, 'numAffected': 73}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 12, 'numAffected': 10}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'White blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 221, 'numAffected': 111}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 7, 'numAffected': 6}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 421, 'numAffected': 305}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 28, 'numAffected': 23}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 74, 'numAffected': 70}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 20, 'numAffected': 18}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 106, 'numAffected': 95}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 80, 'numAffected': 75}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 21, 'numAffected': 21}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 142, 'numAffected': 89}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 183, 'numAffected': 181}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Sarcoidosis of lymph node', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 1, 'numAffected': 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'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Pneumothorax spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Pulmonary artery thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Pulmonary granuloma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Subcutaneous emphysema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Granulomatosis with polyangiitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Peripheral arterial occlusive disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Subclavian vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1269, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 495, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '507', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}, {'id': 'OG001', 'title': 'Best Supportive Care (BSC)', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'comment': 'The upper limit of the 95% confidence interval (CI) was not estimable due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '52.4', 'upperLimit': 'NA'}, {'value': '47.8', 'groupId': 'OG001', 'lowerLimit': '37.0', 'upperLimit': '65.8'}]}]}], 'analyses': [{'pValue': '0.0683', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.848', 'ciLowerLimit': '0.710', 'ciUpperLimit': '1.013', 'statisticalMethod': 'Log Rank', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Stratified Analysis'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 95 months', 'description': 'DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized ITT population was defined as all randomized participants with resected Stage IB \\[tumors ≥ 4 centimetres (cm)\\]-IIIA NSCLC whether or not the participant received the assigned treatment.'}, {'type': 'PRIMARY', 'title': 'DFS in All Randomized Stage II-IIIA Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}, {'id': 'OG001', 'title': 'Best Supportive Care (BSC)', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.4', 'comment': 'The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '42.2', 'upperLimit': 'NA'}, {'value': '40.8', 'groupId': 'OG001', 'lowerLimit': '31.4', 'upperLimit': '57.1'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.830', 'ciLowerLimit': '0.691', 'ciUpperLimit': '0.998', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Stratified Analysis'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 95 months', 'description': 'DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in participants with disease stage II-IIIA. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage II-IIIA population was defined as all randomized participants with extent of disease as either Stage II or Stage IIIA, and is a subset of the ITT population. Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.'}, {'type': 'PRIMARY', 'title': 'DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}, {'id': 'OG001', 'title': 'Best Supportive Care (BSC)', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.5', 'comment': 'The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': '51.8', 'upperLimit': 'NA'}, {'value': '37.3', 'groupId': 'OG001', 'lowerLimit': '30.1', 'upperLimit': '57.8'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.704', 'ciLowerLimit': '0.545', 'ciUpperLimit': '0.910', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Stratified Analysis'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 95 months', 'description': 'DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 ≥1% subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1 subpopulation, defined as ≥1% TC expression by the SP263 immunohistochemistry (IHC) assay, included Stage II-IIIA population with valid PD-L1 SP263 measurement at baseline. Stage II-IIIA population included all randomized participants with extent of disease as either Stage II or Stage III, \\& is a subset of ITT population. Randomized ITT population included all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether the participant received the assigned treatment.'}, {'type': 'SECONDARY', 'title': 'Overall Survival (OS) in the ITT Population', 'timeFrame': 'Up to 20 years', 'description': 'OS was defined as the time from randomization to death from any cause.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2036-08'}, {'type': 'SECONDARY', 'title': 'Disease-free Rate at Year 3 in ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '507', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}, {'id': 'OG001', 'title': 'Best Supportive Care (BSC)', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.43', 'groupId': 'OG000', 'lowerLimit': '57.09', 'upperLimit': '65.77'}, {'value': '55.45', 'groupId': 'OG001', 'lowerLimit': '50.95', 'upperLimit': '59.95'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in event-free rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.98', 'ciLowerLimit': '-0.28', 'ciUpperLimit': '12.23', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Year 3', 'description': 'DFS rate was defined as percentage of participants who were disease-free at Year 3. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.'}, {'type': 'SECONDARY', 'title': 'Disease-free Rate at Year 3 in All Randomized Stage II-IIIA Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}, {'id': 'OG001', 'title': 'Best Supportive Care (BSC)', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.30', 'groupId': 'OG000', 'lowerLimit': '54.61', 'upperLimit': '63.98'}, {'value': '52.64', 'groupId': 'OG001', 'lowerLimit': '47.83', 'upperLimit': '57.46'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in event-free rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.65', 'ciLowerLimit': '-0.06', 'ciUpperLimit': '13.36', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Year 3', 'description': 'DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage II-IIIA population was defined as all randomized participants with extent of disease as either Stage II or Stage III, and is a subset of the ITT population. Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.'}, {'type': 'SECONDARY', 'title': 'Disease-free Rate at Year 3 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}, {'id': 'OG001', 'title': 'Best Supportive Care (BSC)', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '62.72', 'groupId': 'OG000', 'lowerLimit': '56.54', 'upperLimit': '68.90'}, {'value': '52.05', 'groupId': 'OG001', 'lowerLimit': '45.35', 'upperLimit': '58.75'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in event-free rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.67', 'ciLowerLimit': '1.56', 'ciUpperLimit': '19.79', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Year 3', 'description': 'DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1 subpopulation, defined as ≥ 1% TC expression by the SP263 IHC assay, included Stage II-IIIA population with valid PD-L1 SP263 measurement at baseline. Stage II-IIIA population included all randomized participants with extent of disease as either Stage II or Stage III, \\& is a subset of ITT population. Randomized ITT population included all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether the participant received the assigned treatment.'}, {'type': 'SECONDARY', 'title': 'Disease-free Rate at Year 5 in ITT Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '507', 'groupId': 'OG000'}, {'value': '498', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}, {'id': 'OG001', 'title': 'Best Supportive Care (BSC)', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.96', 'groupId': 'OG000', 'lowerLimit': '47.45', 'upperLimit': '56.46'}, {'value': '46.48', 'groupId': 'OG001', 'lowerLimit': '41.91', 'upperLimit': '51.05'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in event-free rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.48', 'ciLowerLimit': '-0.94', 'ciUpperLimit': '11.90', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Year 5', 'description': 'DFS rate was defined as percentage of participants who were disease-free at Year 5. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.'}, {'type': 'SECONDARY', 'title': 'Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '442', 'groupId': 'OG000'}, {'value': '440', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}, {'id': 'OG001', 'title': 'Best Supportive Care (BSC)', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.28', 'groupId': 'OG000', 'lowerLimit': '44.47', 'upperLimit': '54.10'}, {'value': '44.40', 'groupId': 'OG001', 'lowerLimit': '39.57', 'upperLimit': '49.24'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in event-free rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.88', 'ciLowerLimit': '-1.94', 'ciUpperLimit': '11.70', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Year 5', 'description': 'DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Stage II-IIIA population was defined as all randomized participants with extent of disease as either Stage II or Stage III, and is a subset of the ITT population. Randomized ITT population was defined as all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether or not the participant received the assigned treatment.'}, {'type': 'SECONDARY', 'title': 'Disease-free Rate at Year 5 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}, {'id': 'OG001', 'title': 'Best Supportive Care (BSC)', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.15', 'groupId': 'OG000', 'lowerLimit': '46.69', 'upperLimit': '59.61'}, {'value': '42.69', 'groupId': 'OG001', 'lowerLimit': '36.00', 'upperLimit': '49.38'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in event-free rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.46', 'ciLowerLimit': '1.16', 'ciUpperLimit': '19.76', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Year 5', 'description': 'DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1 subpopulation, defined as ≥ 1% TC expression by the SP263 IHC assay, included Stage II-IIIA population with valid PD-L1 SP263 measurement at baseline. Stage II-IIIA population included all randomized participants with extent of disease as either Stage II or Stage III, \\& is a subset of ITT population. Randomized ITT population included all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether the participant received the assigned treatment.'}, {'type': 'SECONDARY', 'title': 'DFS in the PD-L1 (SP263 ≥ 50% TC) Subpopulation Within the Stage II-IIIA Population', 'denoms': [{'units': 'Participants', 'counts': [{'value': '115', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}, {'id': 'OG001', 'title': 'Best Supportive Care (BSC)', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'The median and the 95% CI was not estimable due to insufficient number of participants with events.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '41.1', 'comment': 'The upper limit of the 95% CI was not estimable due to insufficient number of participants with events.', 'groupId': 'OG001', 'lowerLimit': '29.7', 'upperLimit': 'NA'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.503', 'ciLowerLimit': '0.332', 'ciUpperLimit': '0.761', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Stratified Analysis'}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 95 months', 'description': 'DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.', 'unitOfMeasure': 'months', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PD-L1 subpopulation, defined as ≥50% TC expression by the SP263 IHC assay, included Stage II-IIIA population with valid PD-L1 SP263 measurement at baseline. Stage II-IIIA population included all randomized participants with extent of disease as either Stage II or Stage III, \\& is a subset of ITT population. Randomized ITT population included all randomized participants with resected Stage IB (tumors ≥ 4 cm)-IIIA NSCLC whether the participant received the assigned treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 20 years', 'description': 'An AE is any untoward medical occurrence in a participant when administered a pharmaceutical product regardless of the causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2036-08'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '487', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Predose (Hour 0) on Day 1 of Cycles 2, 3, 4, 8, 16 (Cycle length = 21 days), at treatment discontinuation (TD) (up to 12 months), 120 days after last atezolizumab administration (up to 16 months)', 'description': 'The percentage of ATA (Also called anti-drug antibodies (ADA))-positive participants after drug administration were determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ADA evaluable population was defined as all randomized participants who received at least one dose of atezolizumab and who have at least one post-baseline ADA result.'}, {'type': 'SECONDARY', 'title': 'Maximum Plasma Concentration (Cmax) of Atezolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '367', 'spread': '124', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30 min post-infusion on Day 1 of Cycle 1 (Cycle length = 21 days)', 'unitOfMeasure': 'micrograms/millilitres (μg/ml)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-evaluable population was defined as all randomized participants who received any dose of the study treatment and who have evaluable pharmacokinetic samples. Overall number analyzed is the number of participants with data available for analysis.'}, {'type': 'SECONDARY', 'title': 'Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '493', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}], 'classes': [{'title': 'Cycle 1 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '451', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '367', 'spread': '123.5', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 2 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '446', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '87.8', 'spread': '79.3', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 3 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '436', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '141', 'spread': '58.4', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 4 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '419', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '170', 'spread': '57.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 8 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '353', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '222', 'spread': '40.6', 'groupId': 'OG000'}]}]}, {'title': 'Cycle 16 Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '300', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '221', 'spread': '87.3', 'groupId': 'OG000'}]}]}, {'title': 'Treatment Discontinuation Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '404', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '148', 'spread': '221.8', 'groupId': 'OG000'}]}]}, {'title': 'Day 120 Post Last Dose of Atezolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '352', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.58', 'spread': '794.8', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Prior to infusion on Day 1 of Cycles 1, 2, 3, 4, 8, 16 (Cycle length = 21 days), at study discontinuation visit (up to 12 months), Day 120 post last dose of atezolizumab (up to 16 months)', 'unitOfMeasure': 'μg/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK-evaluable population was defined as all randomized participants who received any dose of the study treatment and who have evaluable pharmacokinetic samples. Number analyzed is the number of participants with data available for analyses at the specified timepoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enrollment Phase', 'description': "All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \\[non-squamous cell NSCLC only\\] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred."}, {'id': 'FG001', 'title': 'Atezolizumab', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received 1200 milligrams (mg) of atezolizumab intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles in the randomization phase.'}, {'id': 'FG002', 'title': 'Best Supportive Care (BSC)', 'description': 'Participants who did not experience disease recurrence after chemotherapy in enrollment phase received no treatment in the randomization phase BSC arm.'}], 'periods': [{'title': 'Enrollment Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1280'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Enrolled Safety-evaluable Population', 'comment': 'Enrolled Safety-evaluable population included all eligible participants who were enrolled in the enrollment phase and who received at least one dose of chemotherapy (cisplatin, vinorelbine, docetaxel, gemcitabine, or pemetrexed), regardless of whether they are subsequently randomized or not.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1269'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1005'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '275'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Symptomatic deterioration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '86'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Reason not provided', 'reasons': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Disease relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Randomized Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'NOTE: 507 eligible participants were randomized to receive atezolizumab in the randomization phase.', 'groupId': 'FG001', 'numSubjects': '507'}, {'comment': 'NOTE: 498 eligible participants were randomized to receive BSC in the randomization phase.', 'groupId': 'FG002', 'numSubjects': '498'}]}, {'type': 'Randomized Safety Population', 'comment': 'Randomized safety population included all randomized participants who received at least one dose of the study treatment and all randomized participants who were randomized to the control arm and did not receive any dose of atezolizumab but who had at least one post-baseline safety assessment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '495'}, {'groupId': 'FG002', 'numSubjects': '495'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '507'}, {'groupId': 'FG002', 'numSubjects': '498'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '47'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '11'}]}, {'type': 'Disease Relapse', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '154'}, {'groupId': 'FG002', 'numSubjects': '155'}]}, {'type': 'Ongoing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '301'}, {'groupId': 'FG002', 'numSubjects': '282'}]}]}], 'recruitmentDetails': 'A total of 1280 participants with resectable Stage IB-IIIA non-small cell lung cancer (NSCLC) were enrolled in this study. Participants took part in the study at 227 investigative sites across 22 countries. The study is still ongoing.', 'preAssignmentDetails': 'The study consists of 2 phases, an enrollment phase in which participants received up to 4 cycles of adjuvant cisplatin-based chemotherapy followed by randomized phase in which eligible participants were randomized to receive atezolizumab or best supportive care (BSC) i.e.no treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1280', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Enrollment Phase', 'description': "All participants received up to four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \\[non-squamous cell NSCLC only\\] based on investigator's choice), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occurred."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '8.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '427', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '853', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '1219', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '43', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '307', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '935', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Enrolled population was defined as all eligible participants who were enrolled in the enrollment phase, regardless if they are subsequently randomized or not.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-05-24', 'size': 6423753, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-12T14:43', 'hasProtocol': True}, {'date': '2020-06-30', 'size': 748331, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-12-12T14:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1280}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2015-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2035-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2015-06-04', 'resultsFirstSubmitDate': '2024-12-12', 'studyFirstSubmitQcDate': '2015-06-26', 'lastUpdatePostDateStruct': {'date': '2025-10-10', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-03-27', 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease-Free Survival (DFS) in Intent-to-treat (ITT) Population', 'timeFrame': 'Up to 95 months', 'description': 'DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.'}, {'measure': 'DFS in All Randomized Stage II-IIIA Population', 'timeFrame': 'Up to 95 months', 'description': 'DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in participants with disease stage II-IIIA. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.'}, {'measure': 'DFS in the Programmed Death-ligand 1 (PD-L1) SP263 ≥ 1% Tumor Cell (TC) Subpopulation Within the Stage II-IIIA Population', 'timeFrame': 'Up to 95 months', 'description': 'DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 ≥1% subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.'}], 'secondaryOutcomes': [{'measure': 'Overall Survival (OS) in the ITT Population', 'timeFrame': 'Up to 20 years', 'description': 'OS was defined as the time from randomization to death from any cause.'}, {'measure': 'Disease-free Rate at Year 3 in ITT Population', 'timeFrame': 'Year 3', 'description': 'DFS rate was defined as percentage of participants who were disease-free at Year 3. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.'}, {'measure': 'Disease-free Rate at Year 3 in All Randomized Stage II-IIIA Population', 'timeFrame': 'Year 3', 'description': 'DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.'}, {'measure': 'Disease-free Rate at Year 3 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population', 'timeFrame': 'Year 3', 'description': 'DFS rate was defined as percentage of participants who were disease-free at Year 3. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.'}, {'measure': 'Disease-free Rate at Year 5 in ITT Population', 'timeFrame': 'Year 5', 'description': 'DFS rate was defined as percentage of participants who were disease-free at Year 5. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.'}, {'measure': 'Disease-free Rate at Year 5 in All Randomized Stage II-IIIA Population', 'timeFrame': 'Year 5', 'description': 'DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in participants with disease stage II-IIIA. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.'}, {'measure': 'Disease-free Rate at Year 5 in PD-L1 (SP263 ≥ 1% TC) Subpopulation Within the Stage II-IIIA Population', 'timeFrame': 'Year 5', 'description': 'DFS rate was defined as percentage of participants who were disease-free at Year 5. DFS rate was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. The DFS rate was estimated by the Kaplan-Meier methodology for each treatment arm. Percentages have been rounded off to the nearest decimal.'}, {'measure': 'DFS in the PD-L1 (SP263 ≥ 50% TC) Subpopulation Within the Stage II-IIIA Population', 'timeFrame': 'Up to 95 months', 'description': 'DFS was defined as the time from randomization to the first recurrence of NSCLC or occurrence of new primary NSCLC as determined by the investigator or death, whichever occurs first. DFS was analyzed in PD-L1 subpopulation within the Stage II-IIIA population. Kaplan-Meier methodology was used to estimate the median DFS for each treatment arm.'}, {'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 20 years', 'description': 'An AE is any untoward medical occurrence in a participant when administered a pharmaceutical product regardless of the causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom/disease temporally associated with the use of an investigational product, whether or not considered related to the investigational product.'}, {'measure': 'Percentage of Participants With Anti-Therapeutic Antibodies (ATAs) to Atezolizumab', 'timeFrame': 'Predose (Hour 0) on Day 1 of Cycles 2, 3, 4, 8, 16 (Cycle length = 21 days), at treatment discontinuation (TD) (up to 12 months), 120 days after last atezolizumab administration (up to 16 months)', 'description': 'The percentage of ATA (Also called anti-drug antibodies (ADA))-positive participants after drug administration were determined for participants exposed to atezolizumab. For determining post-baseline incidence, participants were considered to be ADA-positive if they were ADA-negative or had missing data at baseline but developed an ADA response following study drug exposure, or if they were ADA-positive at baseline and the titer of 1 or more post-baseline samples was at least 0.60 titer units (t.u.) greater than the baseline titer result.'}, {'measure': 'Maximum Plasma Concentration (Cmax) of Atezolizumab', 'timeFrame': '30 min post-infusion on Day 1 of Cycle 1 (Cycle length = 21 days)'}, {'measure': 'Minimum Serum Concentration (Cmin) at Steady-State Within a Dosing Interval of Atezolizumab', 'timeFrame': 'Prior to infusion on Day 1 of Cycles 1, 2, 3, 4, 8, 16 (Cycle length = 21 days), at study discontinuation visit (up to 12 months), Day 120 post last dose of atezolizumab (up to 16 months)'}]}, 'conditionsModule': {'conditions': ['Non-Small Cell Lung Cancer']}, 'referencesModule': {'references': [{'pmid': '41416818', 'type': 'DERIVED', 'citation': 'Okada M, Sugawara S, Watanabe Y, Saito H, Chen-Yoshikawa TF, Goto Y, Nishio W, Nakagawa S, Hayashi M, Kenmotsu H. IMpower010: 5-Year Outcomes of Atezolizumab in Japanese Patients With Resected Stage IB-IIIA Non-Small Cell Lung Cancer. Cancer Sci. 2025 Dec 19. doi: 10.1111/cas.70297. Online ahead of print.'}, {'pmid': '40446184', 'type': 'DERIVED', 'citation': 'Felip E, Altorki N, Zhou C, Vallieres E, Csoszi T, Vynnychenko IO, Goloborodko O, Rittmeyer A, Reck M, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Fu C, Ballinger M, Deng Y, Srivastava MK, Bennett E, Gitlitz BJ, Wakelee HA; IMpower010 Study Investigators. Five-Year Survival Outcomes With Atezolizumab After Chemotherapy in Resected Stage IB-IIIA Non-Small Cell Lung Cancer (IMpower010): An Open-Label, Randomized, Phase III Trial. J Clin Oncol. 2025 Jul 20;43(21):2343-2349. doi: 10.1200/JCO-24-01681. Epub 2025 May 30.'}, {'pmid': '37903590', 'type': 'DERIVED', 'citation': 'Zhou C, Srivastava MK, Xu H, Felip E, Wakelee H, Altorki N, Reck M, Liersch R, Kryzhanivska A, Oizumi S, Tanaka H, Hamm J, McCune SL, Bennett E, Gitlitz B, McNally V, Ballinger M, McCleland M, Zou W, Das Thakur M, Novello S. Comparison of SP263 and 22C3 immunohistochemistry PD-L1 assays for clinical efficacy of adjuvant atezolizumab in non-small cell lung cancer: results from the randomized phase III IMpower010 trial. J Immunother Cancer. 2023 Oct;11(10):e007047. doi: 10.1136/jitc-2023-007047.'}, {'pmid': '37467930', 'type': 'DERIVED', 'citation': 'Felip E, Altorki N, Zhou C, Vallieres E, Martinez-Marti A, Rittmeyer A, Chella A, Reck M, Goloborodko O, Huang M, Belleli R, McNally V, Srivastava MK, Bennett E, Gitlitz BJ, Wakelee HA. Overall survival with adjuvant atezolizumab after chemotherapy in resected stage II-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase III trial. Ann Oncol. 2023 Oct;34(10):907-919. doi: 10.1016/j.annonc.2023.07.001. Epub 2023 Jul 17.'}, {'pmid': '35947027', 'type': 'DERIVED', 'citation': 'Mohindra NA, Patel JD. Top advances in lung cancer, 2021. Cancer. 2022 Oct 1;128(19):3434-3437. doi: 10.1002/cncr.34406. Epub 2022 Aug 10.'}, {'pmid': '34555333', 'type': 'DERIVED', 'citation': 'Felip E, Altorki N, Zhou C, Csoszi T, Vynnychenko I, Goloborodko O, Luft A, Akopov A, Martinez-Marti A, Kenmotsu H, Chen YM, Chella A, Sugawara S, Voong D, Wu F, Yi J, Deng Y, McCleland M, Bennett E, Gitlitz B, Wakelee H; IMpower010 Investigators. Adjuvant atezolizumab after adjuvant chemotherapy in resected stage IB-IIIA non-small-cell lung cancer (IMpower010): a randomised, multicentre, open-label, phase 3 trial. Lancet. 2021 Oct 9;398(10308):1344-1357. doi: 10.1016/S0140-6736(21)02098-5. Epub 2021 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase III, global, multicenter, open-label, randomized study to compare the efficacy and safety of 16 cycles (1 cycle duration=21 days) of atezolizumab (MPDL3280A) treatment compared with best supportive care (BSC) in participants with Stage IB-Stage IIIA non-small cell lung cancer (NSCLC) following resection and adjuvant chemotherapy, as measured by disease-free survival (DFS) as assessed by the investigator and overall survival (OS). Participants, after completing up to 4 cycles of adjuvant cisplatin-based chemotherapy, will be randomized in a 1:1 ratio to receive atezolizumab for 16 cycles or BSC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nInclusion Criteria for Enrollment Phase\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Histological or cytological diagnosis of Stage IB (tumors greater than or equal to \\[\\>/=\\] 4 centimeters \\[cm\\])-IIIA (T2-3 N0, T1-3 N1, T1-3 N2, T4 N0-1) NSCLC (per the Union Internationale Contre le Cancer staging system (UICC)/American Joint Committee on Cancer staging system (AJCC) staging system, 7th edition; Detterbeck et al. 2009)\n* Participants must have had complete resection of NSCLC 4-12 weeks (\\>/=28 days and less than or equal to \\[\\</=\\] 84 days) prior to enrollment and must be adequately recovered from surgery\n* If mediastinoscopy was not performed preoperatively, it is required that, at a minimum, mediastinal lymph node systematic sampling will have occurred. Systematic sampling is defined as removal of at least one representative lymph node at specified levels. MLND entails resection of all lymph nodes at those same levels. For a right thoracotomy, sampling or MLND is required at levels 4 and 7 and for a left thoracotomy, levels 5 and/or 6 and 7. Exceptions will be granted if there is clear documentation in the operative report or in a separately submitted addendum by the surgeon of exploration of the required lymph node areas, the participant will be considered eligible if no lymph nodes are found in those areas; if participants have documented N2 disease in one level (per the UICC/AJCC staging system, 7th edition; Detterbeck et al. 2009), not all levels need to be sampled; if the preoperative staging imaging results (contrast computed tomography \\[CT\\] and positron emission tomography \\[PET\\] scans) do not suggest evidence of disease in the mediastinum, the participant will be considered eligible if N2 nodal sampling is not performed per surgeon's decision\n* Eligible to receive a cisplatin-based chemotherapy regimen\n* Adequate hematologic and end-organ function\n* Women who are not postmenopausal (\\>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of cisplatin-based chemotherapy\n\nInclusion Criteria for Randomized Phase - Women who are not postmenopausal (\\>/=12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of atezolizumab or BSC\n\nExclusion Criteria:\n\nExclusion Criteria for Enrollment Phase\n\n* Illness or condition that may interfere with a participant's capacity to understand, follow, and/or comply with study procedures\n* Pregnant and lactating women\n* Treatment with prior systemic chemotherapy: Chemotherapy for early stage of malignancy with curative intent, provided that the last dose received was more than 5 years prior to enrollment and low-dose chemotherapy for non-malignant conditions may be allowed upon approval by the Medical Monitor\n* Hormonal cancer therapy or radiation therapy as prior cancer treatment within 5 years before enrollment\n* Treatment with any other investigational agent with therapeutic intent within 28 days prior to enrollment\n* Participants with hearing impairment\n* Known sensitivity to any component of the chemotherapy regimen the participant will be assigned to, or to mannitol\n* Prior treatment with cluster of differentiation (CD) 137 (CD137) agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti programmed death ligand 1 (PD-L1) therapeutic antibodies\n* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS greater than \\[\\>\\] 90 percent \\[%\\]) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)\n* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins\n* Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation\n* History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n* Positive test for human immunodeficiency virus (HIV)\n* Participants with active hepatitis B (chronic or acute; defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) or hepatitis C\n* Active tuberculosis\n* Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within the previous 3 months, unstable arrhythmias, or unstable angina\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan\n* Prior allogeneic bone marrow transplantation or solid organ transplant\n* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications\n* Known tumor PD-L1 expression status as determined by an immunohistochemistry (IHC) assay from other clinical studies (e.g., participants whose PD-L1 expression status was determined during screening for entry into a study with anti-PD-1 or anti-PD-L1 antibodies but were not eligible are excluded)\n\nSpecific Exclusions for Pemetrexed Treatment\n\n\\- Participants with squamous cell histology\n\nExclusion Criteria for Randomized Phase\n\n* Signs or symptoms of infection within 14 days prior to randomization (severe infection within 28 days prior to randomization), including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia\n* Received therapeutic oral or intravenous (IV) antibiotics within 14 days prior to randomization\n* Major surgical procedure within 28 days prior to randomization or anticipation of need for a major surgical procedure during the course of the study\n* Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live attenuated vaccine will be required during the study\n* Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization: Prior treatment with cancer vaccines is allowed\n* Treatment with systemic corticosteroids or other immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor \\[anti-TNF\\] agents) within 14 days prior to randomization"}, 'identificationModule': {'nctId': 'NCT02486718', 'briefTitle': 'Study to Assess Safety and Efficacy of Atezolizumab (MPDL3280A) Compared to Best Supportive Care Following Chemotherapy in Patients With Lung Cancer [IMpower010]', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Phase III, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Atezolizumab (Anti-PD-L1 Antibody) Compared With Best Supportive Care Following Adjuvant Cisplatin-Based Chemotherapy in Patients With Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': 'GO29527'}, 'secondaryIdInfos': [{'id': '2014-003205-15', 'type': 'EUDRACT_NUMBER'}, {'id': '2023-505981-26-00', 'type': 'REGISTRY', 'domain': 'CTIS (EU)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atezolizumab', 'description': "Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \\[non-squamous cell NSCLC only\\]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: Participants will receive atezolizumab 1200 milligrams (mg) intravenously (IV) every 3 weeks (Q3W) for sixteen 21-day cycles and will undergo periodic chest X-ray and CT scan.", 'interventionNames': ['Drug: Atezolizumab', 'Drug: Cisplatin', 'Drug: Vinorelbine', 'Drug: Docetaxel', 'Drug: Gemcitabine', 'Drug: Pemetrexed']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Best Supportive Care', 'description': "Enrollment Phase: Participants will receive four 21-day cycles of cisplatin-based chemotherapy (cisplatin plus either vinorelbine or docetaxel or gemcitabine or pemetrexed \\[non-squamous cell NSCLC only\\]), unless unacceptable toxicity, disease relapse, or participant's decision to discontinue occur. Randomization Phase: After enrollment phase participants will receive only the best supportive care and will undergo periodic chest X-ray and CT scan.", 'interventionNames': ['Drug: Cisplatin', 'Drug: Vinorelbine', 'Drug: Docetaxel', 'Drug: Gemcitabine', 'Drug: Pemetrexed']}], 'interventions': [{'name': 'Atezolizumab', 'type': 'DRUG', 'otherNames': ['MPDL3280A; TECENTRIQ'], 'description': 'Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).', 'armGroupLabels': ['Atezolizumab']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Participants will receive cisplatin 75 milligrams per square meter (mg/m\\^2) IV on Day 1 of up to four 21-day cycles.', 'armGroupLabels': ['Atezolizumab', 'Best Supportive Care']}, {'name': 'Vinorelbine', 'type': 'DRUG', 'description': 'Participants will receive vinorelbine 30 mg/m\\^2 IV on Days 1 and 8 of each of the four 21-day cycles.', 'armGroupLabels': ['Atezolizumab', 'Best Supportive Care']}, {'name': 'Docetaxel', 'type': 'DRUG', 'description': 'Participants will receive docetaxel 75 mg/m\\^2 IV on Day 1 of each of the four 21-day cycles.', 'armGroupLabels': ['Atezolizumab', 'Best Supportive Care']}, {'name': 'Gemcitabine', 'type': 'DRUG', 'description': 'Participants will receive gemcitabine 1250 mg/m\\^2 IV on Days 1 and 8 of each of the four 21-day cycles.', 'armGroupLabels': ['Atezolizumab', 'Best Supportive Care']}, {'name': 'Pemetrexed', 'type': 'DRUG', 'description': 'Participants will receive pemetrexed 500 mg/m\\^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.', 'armGroupLabels': ['Atezolizumab', 'Best Supportive Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '92024', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'California Cancer Associates for Research & Excellence, Inc.', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92708', 'city': 'Fountain Valley', 'state': 'California', 'country': 'United States', 'facility': 'Compassionate Cancer Care Medical Group, Inc', 'geoPoint': {'lat': 33.70918, 'lon': -117.95367}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of California Los Angeles', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94589', 'city': 'Vallejo', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 38.10409, 'lon': -122.25664}}, {'zip': '94596', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente - 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{'zip': '34376', 'city': 'Immenhausen', 'country': 'Germany', 'facility': 'Fachklinik für Lungenerkrankungen', 'geoPoint': {'lat': 51.42763, 'lon': 9.48017}}, {'zip': '76137', 'city': 'Karlsruhe', 'country': 'Germany', 'facility': 'Vincentius-Diakonissen-Kliniken gAG', 'geoPoint': {'lat': 49.00937, 'lon': 8.40444}}, {'zip': '56073', 'city': 'Koblenz Am Rhein', 'country': 'Germany', 'facility': 'Katholisches Klinikum Marienhof'}, {'zip': '81925', 'city': 'München', 'country': 'Germany', 'facility': 'Klinikum Bogenhausen', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis für Hämatologie und Onkologie', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '26121', 'city': 'Oldenburg', 'country': 'Germany', 'facility': 'Pius-Hospital Oldenburg', 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'zip': '93049', 'city': 'Regensburg', 'country': 'Germany', 'facility': 'Krankenhaus Barmherzige Bruder 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