Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-01-18 @ 7:51 PM
Study NCT ID:
NCT02590003
Status:
TERMINATED
Last Update Posted:
2018-02-28
First Post:
2015-10-12
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Single Agent Versus Combination Chemotherapy to Treat High-risk Elderly With Non-small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D016190', 'term': 'Carboplatin'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rogerio.lilenbaum@yale.edu', 'phone': '(203) 200-5864', 'title': 'Rogerio C. Lilenbaum, MD, Professor of Medicine (Medical Oncology); Chief Medical Officer of Smilow', 'organization': 'Yale University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Single Agent Chemotherapy', 'description': '-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nNab-paclitaxel', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 2, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Platinum-based Doublet Chemotherapy', 'description': '* Carboplatin AUC 5 30 minute infusion IV on day 1\n* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nCarboplatin\n\nNab-paclitaxel', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Blood disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Confusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Creatinine Increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema Limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Eye Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypocalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 7, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Mucositis oral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral sensory neuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'White blood cell decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Edema limbs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Thromboembolic event', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Treatment Failure-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platinum-based Doublet Chemotherapy', 'description': '* Carboplatin AUC 5 30 minute infusion IV on day 1\n* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nCarboplatin\n\nNab-paclitaxel'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': '-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nNab-paclitaxel'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Overall Response Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platinum-based Doublet Chemotherapy', 'description': '* Carboplatin AUC 5 30 minute infusion IV on day 1\n* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nCarboplatin\n\nNab-paclitaxel'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': '-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nNab-paclitaxel'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'start of treatment to disease progression/recurrence, up to 12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.'}, {'type': 'SECONDARY', 'title': 'Progression-free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platinum-based Doublet Chemotherapy', 'description': '* Carboplatin AUC 5 30 minute infusion IV on day 1\n* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nCarboplatin\n\nNab-paclitaxel'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': '-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nNab-paclitaxel'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'start of treatment to disease progression, up to 12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.'}, {'type': 'SECONDARY', 'title': 'Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platinum-based Doublet Chemotherapy', 'description': '* Carboplatin AUC 5 30 minute infusion IV on day 1\n* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nCarboplatin\n\nNab-paclitaxel'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': '-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nNab-paclitaxel'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 12 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment.'}, {'type': 'SECONDARY', 'title': 'Grade 3-5 Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platinum-based Doublet Chemotherapy', 'description': '* Carboplatin AUC 5 30 minute infusion IV on day 1\n* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nCarboplatin\n\nNab-paclitaxel'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': '-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nNab-paclitaxel'}], 'classes': [{'title': 'Overall', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to week 13', 'description': 'Adverse events were characterized using Common Terminology Criteria for Adverse Events (CTCAE)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platinum-based Doublet Chemotherapy', 'description': '* Carboplatin AUC 5 30 minute infusion IV on day 1\n* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nCarboplatin\n\nNab-paclitaxel'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': '-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nNab-paclitaxel'}], 'classes': [{'categories': [{'measurements': [{'value': '89', 'spread': 'NA', 'comment': 'Standard deviation is not calculated.', 'groupId': 'OG000'}, {'value': '44', 'spread': '26.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline', 'description': 'The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platinum-based Doublet Chemotherapy', 'description': '* Carboplatin AUC 5 30 minute infusion IV on day 1\n* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nCarboplatin\n\nNab-paclitaxel'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': '-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nNab-paclitaxel'}], 'classes': [{'categories': [{'measurements': [{'value': '60.5', 'spread': '19.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'week 6', 'description': 'The higher the score, the greater the symptoms. The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained. Symptoms were measured following 2 21-day cycles of chemotherapy.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 2 patients were assessed at this timepoint.'}, {'type': 'SECONDARY', 'title': 'Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platinum-based Doublet Chemotherapy', 'description': '* Carboplatin AUC 5 30 minute infusion IV on day 1\n* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nCarboplatin\n\nNab-paclitaxel'}, {'id': 'OG001', 'title': 'Single Agent Chemotherapy', 'description': '-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nNab-paclitaxel'}], 'timeFrame': 'week 12', 'description': 'The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. Symptoms were measured following 4 21-day cycles of chemotherapy.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated after only 3 patients were randomized and all 3 did not respond to treatment, these data were not collected at week 12'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Platinum-based Doublet Chemotherapy', 'description': '* Carboplatin AUC 5 30 minute infusion IV on day 1\n* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nCarboplatin\n\nNab-paclitaxel'}, {'id': 'FG001', 'title': 'Single Agent Chemotherapy', 'description': '-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nNab-paclitaxel'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Platinum-based Doublet Chemotherapy', 'description': '* Carboplatin AUC 5 30 minute infusion IV on day 1\n* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nCarboplatin\n\nNab-paclitaxel'}, {'id': 'BG001', 'title': 'Single Agent Chemotherapy', 'description': '-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle\n\nNab-paclitaxel'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Trial was stopped after non-response to treatment.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-30', 'studyFirstSubmitDate': '2015-10-12', 'resultsFirstSubmitDate': '2017-11-03', 'studyFirstSubmitQcDate': '2015-10-27', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-30', 'studyFirstPostDateStruct': {'date': '2015-10-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment Failure-free Survival', 'timeFrame': '90 days'}], 'secondaryOutcomes': [{'measure': 'Overall Response Rate', 'timeFrame': 'start of treatment to disease progression/recurrence, up to 12 months'}, {'measure': 'Progression-free Survival', 'timeFrame': 'start of treatment to disease progression, up to 12 months'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 12 months'}, {'measure': 'Grade 3-5 Adverse Events', 'timeFrame': 'Up to week 13', 'description': 'Adverse events were characterized using Common Terminology Criteria for Adverse Events (CTCAE)'}, {'measure': 'Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)', 'timeFrame': 'baseline', 'description': 'The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained.'}, {'measure': 'Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)', 'timeFrame': 'week 6', 'description': 'The higher the score, the greater the symptoms. The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. A maximum score of 136 could be obtained. Symptoms were measured following 2 21-day cycles of chemotherapy.'}, {'measure': 'Symptom Assessment (Measured by FACT-L Symptom Assessment Scale)', 'timeFrame': 'week 12', 'description': 'The FACT-L is measure of symptoms associated with lung cancer. The higher the score, the greater the symptoms. Symptoms were measured following 4 21-day cycles of chemotherapy.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Carcinoma, Non-small Cell Lung']}, 'descriptionModule': {'briefSummary': 'This study will enroll elderly patients with advanced non-small cell lung cancer who are at high risk of developing chemotherapy toxicity (side effects). Patients will receive treatment with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single agent nab-paclitaxel of chemotherapy. Response to treatment and treatment toxicity will be compared in the two treatment groups to determine the best treatment strategy for this group of patients.', 'detailedDescription': 'The primary objective of this trial is to compare the treatment failure-free survival rate in high-risk elderly patients, identified by geriatric assessment, treated with either a platinum-based doublet chemotherapy with carboplatin/nab-paclitaxel or single agent nab-paclitaxel in advanced non-small cell lung cancer. Treatment failure-free survival is the most appropriate primary outcome as it captures excessive toxicity due to chemotherapy in addition to death and disease progression.\n\nThe secondary objectives are to evaluate grade 3-5 toxicities, overall response rate, progression free survival, symptom assessment, and overall survival between the two randomization arms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '71 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient able and willing to comply with study procedures as per protocol, including the geriatric assessment at the time of study enrollment.\n2. Patient able to understand and willing to sign and date the written voluntary informed consent form (ICF) at screening visit prior to any protocol-specific procedures.\n3. Patients must have histological or cytological confirmed primary non-small cell lung cancer (adenocarcinoma, large cell carcinoma, squamous, or unspecified). Disease must be stage IV Non-Small Cell Lung Cancer (NSCLC). Disease may be either newly diagnosed or recurrent after previous surgery and/or irradiation. Primary or metastatic site for biopsy is allowed\n4. Patients may have measurable or non-measurable disease documented by CT or MRI. The CT from a combined PET/CT may be used to document only non-measurable disease. Measurable disease must be assessed within 30 days prior to registration per response evaluation criteria in solid tumors (RECIST) v1.1. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease. Non- measurable disease must be assessed within 30 days prior to registration. All disease must be assessed and documented on the Baseline Tumor Assessment Form.\n5. Prior chemotherapy for curative intent is permitted providing the cytotoxic chemotherapy was completed ≥12 months prior to enrollment. Patients must have a CT or MRI scan of the brain to evaluate for CNS disease within 30 days prior to registration. Patient must not have brain metastases unless: (1) metastases have been treated and have remained controlled for at least two weeks following treatment, AND (2) patient has no residual neurological dysfunction off corticosteroids for at least 1 day. Any radiation therapy completed prior to chemotherapy, except gamma-knife radiosurgery, 1 week prior to chemotherapy.\n6. Age \\>70 years of age at time of signing of the informed consent form.\n7. Life expectancy of greater than 12 weeks.\n8. ECOG performance status 0-2 (See Appendix A)\n9. Patients must have a comprehensive geriatric assessment and chemotherapy toxicity assessment score between 7-17 (See Appendix B, D)\n10. Patients must have normal organ and marrow function as defined below:\n\n * Leukocytes \\>3,000/mcL\n * ANC \\> 1,500 cells/mm3Hemoglobin \\> 9.0g/dL\n * Platelets \\>100,000 cells/mm3\n * Total bilirubin \\< 1.5 mg/dL (unless there is a known history of Gilberts Syndrome).\n * AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal\n * Alkaline phosphatase \\< 2.5 X upper limit of normal in the absence of liver or bone metastasis, or ≤ 5.0 × upper limit of normal range if bone or liver metastases\n * Creatinine clearance \\>25 mL/min or creatinine \\<1.5 mg/dL\n11. HIV-positive patients on combination antiretroviral therapy are eligible if they have been on ARVs for ≥6 months and undetectable viral loads.\n12. Patients must not have documented evidence of acute hepatitis or have an active or uncontrolled infection.\n13. No other priormalignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.\n14. Ability to understand and the willingness to sign a written informed consent document in English or a Spanish consent "short form". If language other than English or Spanish, then interpreter will be used to sign English consent form.\n15. Patients must have \\< Grade 2 pre-existing peripheral neuropathy (per CTCAE)\n\nExclusion Criteria\n\n1. Patients who have had palliative chemotherapy prior to entering the study \\<12 months from enrollment or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.\n2. Patients may not be receiving any other investigational agents or have received immunotherapy.\n3. Known EGFR or ALK mutated disease (molecular testing not required prior to study entry)\n4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, or nab-paclitaxel.\n5. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.\n6. Preexisting peripheral neuropathy of Grade 2, 3, or 4 (per Common Terminology Criteria for Adverse Events v4.0)\n7. Evidence of active brain metastases, including leptomeningeal involvement (prior evidence of brain metastasis are permitted only if treated and stable and off therapy for ≥ 2 weeks prior to signing Informed consent form. Magnetic Resonance Imaging of the brain (or Computed Tomography scan w/contrast) is preferred for diagnosis.'}, 'identificationModule': {'nctId': 'NCT02590003', 'briefTitle': 'Single Agent Versus Combination Chemotherapy to Treat High-risk Elderly With Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'A Randomized Phase II Trial of Combination Versus Single Agent Chemotherapy in High-risk Elderly Patients With Advanced Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '1403013529'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Platinum-based doublet chemotherapy', 'description': '* Carboplatin AUC 5 30 minute infusion IV on day 1\n* Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle', 'interventionNames': ['Drug: Carboplatin', 'Drug: Nab-paclitaxel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single agent chemotherapy', 'description': '-Nab-paclitaxel 100mg/mg2 30 minute infusion IV on days 1, 8 of a 21 day cycle', 'interventionNames': ['Drug: Nab-paclitaxel']}], 'interventions': [{'name': 'Carboplatin', 'type': 'DRUG', 'armGroupLabels': ['Platinum-based doublet chemotherapy']}, {'name': 'Nab-paclitaxel', 'type': 'DRUG', 'armGroupLabels': ['Platinum-based doublet chemotherapy', 'Single agent chemotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale Cancer Center', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Rogerio Lilenbaum, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}