Ignite Creation Date:
2025-12-24 @ 3:27 PM
Ignite Modification Date:
2026-01-30 @ 11:10 PM
Study NCT ID:
NCT01722292
Status:
TERMINATED
Last Update Posted:
2018-12-28
First Post:
2012-11-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of LY2940680 in Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'South Korea']}, 'conditionBrowseModule': {'meshes': [{'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}], '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': 'C581399', 'term': 'LY2940680'}, {'id': 'D016190', 'term': 'Carboplatin'}, {'id': 'D005047', 'term': 'Etoposide'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.'}}, 'adverseEventsModule': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 9, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 14, 'numAffected': 8}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Thrombocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 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'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Abdominal pain upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 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'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Malignant neoplasm progression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nervous system disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Hypovolaemic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Phase 1b: Recommended Phase 2 Dose of LY2940680: Maximum Tolerated Dose (MTD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b', 'description': 'Cohort 1:\n\n100 milligrams (mg) LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.\n\nCohort 2:\n\n200 milligrams (mg) LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.\n\nCohort 3:\n\n400 milligrams (mg) LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '400', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Completion of the Phase 1b (Up To 12 Months)', 'description': 'MTD was defined as the highest tested dose that has \\<33% probability of causing a dose-limiting toxicity(DLT). DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and fulfills any one of the following criterion using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE),version 4.0:Grade 3 non-hematological toxicity except nausea, vomiting, constipation, diarrhea, fatigue, or anorexia that is manageable with appropriate care,transient(i.e., ≤5 days) Grade 3 elevations of alanine aminotransferase(ALT) and/or aspartate aminotransferase(AST), without evidence of other hepatic injury, in the setting of preexisting hepatic metastasis, ≥Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia of any duration,CTCAE Grade 4 hematological toxicity of \\>5 days duration and any febrile neutropenia. any other significant toxicity deemed by the primary investigator and Lilly clinical research personnel to be dose-limiting.', 'unitOfMeasure': 'milligrams (mg)', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and were enrolled in Phase1b of the study.'}, {'type': 'PRIMARY', 'title': 'Phase 2: Progression-Free Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 400 mg LY2940680 + C+ E', 'description': '400 mg LY2940680 administered orally QD cycles 1-6 (21 day cycle).\n\n(AUC) 5 carboplatin (C) administered by IV infusion on day 1 each cycle.\n\n100 mg/m\\^2 etoposide (E) administered by IV infusion on days 1, 2, 3 of each cycle, followed by a single agent of LY2940680.'}, {'id': 'OG001', 'title': 'Phase 2: Placebo + C + E', 'description': 'Placebo administered orally QD for 6 cycles.\n\n(AUC) 5 carboplatin administered by IV infusion on day 1 of each cycle.\n\n100 mg/m\\^2 etoposide administered by IV infusion on days 1, 2, 3 of each cycle.'}], 'timeFrame': 'Randomization to Measured Progressive Disease or Death of Any Cause (Estimated as 18 Months)', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680, LSN3185556 at the Recommended Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: 100 mg LY2940680 + C + E', 'description': '100 mg LY2940680 administered orally once daily (QD) for 6 cycles.\n\n100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}, {'id': 'OG001', 'title': 'Phase 1b: 200 mg LY2940680 + C + E', 'description': '200 mg LY2940680 administered orally once daily (QD) for 6 cycles.\n\n100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}, {'id': 'OG002', 'title': 'Phase 1B: 400 mg LY2940680 + C + E', 'description': '400 mg LY2940680 administered orally once daily (QD) for 6 cycles.\n\n100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}], 'classes': [{'title': 'LY2940680 Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '0.491', 'spread': '64', 'groupId': 'OG000'}, {'value': '1.01', 'spread': '36', 'groupId': 'OG001'}, {'value': '1.56', 'spread': '35', 'groupId': 'OG002'}]}]}, {'title': 'LY2940680 Cycle 2, Day 1', 'categories': [{'measurements': [{'value': '0.578', 'spread': '71', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '66', 'groupId': 'OG001'}, {'value': '3.29', 'spread': '33', 'groupId': 'OG002'}]}]}, {'title': 'LSN3185556 Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '0.444', 'spread': '33', 'groupId': 'OG000'}, {'value': '0.737', 'spread': '138', 'groupId': 'OG001'}, {'value': '1.75', 'spread': '47', 'groupId': 'OG002'}]}]}, {'title': 'LSN3185556 Cycle 2, Day 1', 'categories': [{'measurements': [{'value': '1.6', 'spread': '35', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '90', 'groupId': 'OG001'}, {'value': '6', 'spread': '59', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours', 'unitOfMeasure': 'microgram per milliliter (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and were enrolled in Phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Carboplatin and Etoposide at the Recommended Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: LY2940680 + C + E', 'description': 'LY2940680 administered orally once daily (QD) for 6 cycles.\n\n100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}], 'classes': [{'title': 'Total Carboplatin Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '16.7', 'spread': '33', 'groupId': 'OG000'}]}]}, {'title': 'Total Carboplatin Cycle 2, Day 1', 'categories': [{'measurements': [{'value': '13.1', 'spread': '42', 'groupId': 'OG000'}]}]}, {'title': 'Etoposide Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '20.9', 'spread': '18', 'groupId': 'OG000'}]}]}, {'title': 'Etoposide Cycle 2, Day 1', 'categories': [{'measurements': [{'value': '18.4', 'spread': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours', 'unitOfMeasure': 'microgram per milliliter (µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and were enrolled in Phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.\n\nC and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for LY2940680 and LSN3185556 at the Recommended Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: 100 mg LY2940680 + C+ E', 'description': '100 mg LY2940680 administered orally once daily (QD) for 6 cycles.\n\n100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}, {'id': 'OG001', 'title': 'Phase 1b: 200 mg LY2940680 + C+ E', 'description': '200 mg LY2940680 administered orally once daily (QD) for 6 cycles.\n\n100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}, {'id': 'OG002', 'title': 'Phase 1b: 400 mg LY2940680 + C+ E', 'description': '400 mg LY2940680 administered orally once daily (QD) for 6 cycles.\n\n100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}], 'classes': [{'title': 'LY2940680 Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '6.34', 'spread': '57', 'groupId': 'OG000'}, {'value': '8.96', 'spread': '39', 'groupId': 'OG001'}, {'value': '15.9', 'spread': '27', 'groupId': 'OG002'}]}]}, {'title': 'LY2940680 Cycle 2, Day 1', 'categories': [{'measurements': [{'value': '7.86', 'spread': '67', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '64', 'groupId': 'OG001'}, {'value': '37.6', 'spread': '43', 'groupId': 'OG002'}]}]}, {'title': 'LSN3185556 Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '7.23', 'spread': '49', 'groupId': 'OG000'}, {'value': '16.2', 'spread': '67', 'groupId': 'OG001'}, {'value': '26', 'spread': '37', 'groupId': 'OG002'}]}]}, {'title': 'LSN3185556 Cycle 2, Day 1', 'categories': [{'measurements': [{'value': '22.7', 'spread': '58', 'groupId': 'OG000'}, {'value': '31.1', 'spread': '111', 'groupId': 'OG001'}, {'value': '92.5', 'spread': '72', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours', 'unitOfMeasure': 'Hour*microgram per milliliter (h.µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for Etoposide and as AUC₀-₆ for Carboplatin at the Recommended Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: LY2940680 + C+ E', 'description': 'LY2940680 administered orally once daily (QD) for 6 cycles.\n\n100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}], 'classes': [{'title': 'Total Carboplatin Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '37.2', 'spread': '23', 'groupId': 'OG000'}]}]}, {'title': 'Total Carboplatin Cycle 2, Day 1', 'categories': [{'measurements': [{'value': '32.0', 'spread': '25', 'groupId': 'OG000'}]}]}, {'title': 'Etoposide Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '104', 'spread': '22', 'groupId': 'OG000'}]}]}, {'title': 'Etoposide Cycle 2, Day 1', 'categories': [{'measurements': [{'value': '96.1', 'spread': '20', 'groupId': 'OG000'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours', 'unitOfMeasure': 'Hour*microgram per milliliter (h.µg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.\n\nC and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: 100 mg LY2940680 + C+ E', 'description': '100 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}, {'id': 'OG001', 'title': 'Phase 1b: 200 mg LY2940680 + C+ E', 'description': '200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}, {'id': 'OG002', 'title': 'Phase 1b: 400 mg LY2940680 + C+ E', 'description': '400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000', 'lowerLimit': '16.4', 'upperLimit': '83.6'}, {'value': '50', 'groupId': 'OG001', 'lowerLimit': '16.4', 'upperLimit': '83.6'}, {'value': '57.1', 'groupId': 'OG002', 'lowerLimit': '35.4', 'upperLimit': '78.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Study Completion Up to 39 Months', 'description': 'ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of drug.'}, {'type': 'SECONDARY', 'title': 'Phase 1b: Percentage Inhibition of Expression Levels of Gli1 in Skin Cells', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: 100 mg LY2940680', 'description': '100 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}, {'id': 'OG001', 'title': 'Phase 1b: 200 mg LY2940680', 'description': '200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}, {'id': 'OG002', 'title': 'Phase 1b: 400 mg LY2940680', 'description': '400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.7', 'groupId': 'OG000', 'lowerLimit': '75.9', 'upperLimit': '94.9'}, {'value': '95.1', 'groupId': 'OG001', 'lowerLimit': '94.5', 'upperLimit': '97.2'}, {'value': '94.8', 'groupId': 'OG002', 'lowerLimit': '90.7', 'upperLimit': '97.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Cycle 2 Day 1, Cycle 7 Day 1', 'description': 'The gene expression data (Gli1) was normalized and the level of percentage of Gli1 inhibition post treatment was calculated.', 'unitOfMeasure': 'Percentage of Gli 1 Inhibition', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of drug and had samples available.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Overall Survival', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 400 mg LY2940680 + C+ E', 'description': '400 mg LY2940680 administered orally QD cycles 1-6 (21 day cycle)\n\n(AUC) 5 carboplatin (C) administered by IV infusion on day 1 each cycle.\n\n100 mg/m\\^2 etoposide (E) administered by IV infusion on days 1, 2, 3 of each cycle, followed by a single agent of LY2940680.'}, {'id': 'OG001', 'title': 'Phase 2: Placebo + C + E', 'description': 'Placebo administered orally QD for 6 cycles.\n\n(AUC) 5 carboplatin administered by IV infusion on day 1 of each cycle.\n\n100 mg/m\\^2 etoposide administered by IV infusion on days 1, 2, 3 of each cycle.'}], 'timeFrame': 'Randomization to Study Completion (Estimated as 38 Months)', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Percent Change in Tumor Size (CTS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: 400 mg LY2940680 + C+ E', 'description': '400 mg LY2940680 administered orally QD cycles 1-6 (21 day cycle)\n\n(AUC) 5 carboplatin (C) administered by IV infusion on day 1 each cycle.\n\n100 mg/m\\^2 etoposide (E) administered by IV infusion on days 1, 2, 3 of each cycle, followed by a single agent of LY2940680.'}, {'id': 'OG001', 'title': 'Phase 2: Placebo + C + E', 'description': 'Placebo administered orally QD for 6 cycles.\n\n(AUC) 5 carboplatin administered by IV infusion on day 1 of each cycle.\n\n100 mg/m\\^2 etoposide administered by IV infusion on days 1, 2, 3 of each cycle.'}], 'timeFrame': 'Randomization to End of Cycle 2 (Estimated as 24 Months)', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.'}, {'type': 'SECONDARY', 'title': 'Phase 2: Number of Participants With a Complete or Partial Tumor Response (Overall Response Rate)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 2: Placebo + C + E', 'description': 'Induction: Cycles 1-6 (21 day cycles) Placebo administered orally once daily in combination with etoposide 100 mg/m\\^2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle.\n\nMaintenance: Cycles 7+ (21 day cycles) Placebo administered orally once daily. Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.'}, {'id': 'OG001', 'title': 'Phase 2: LY2940680 + C+ E', 'description': 'Induction: Cycles 1-6 (21 day cycles) LY2940680 (dose to be determined in Phase 1b portion) administered orally once daily in combination with etoposide 100 mg/m\\^2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle.\n\nMaintenance: Cycles 7+ (21 day cycles). LY2940680 (dose to be determined in Phase 1 portion) administered orally once daily.'}], 'timeFrame': 'Randomization to Study Completion (Estimated as 38 Months)', 'reportingStatus': 'POSTED', 'populationDescription': 'Zero participants analyzed. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of LY2940680 andLSN3185556 at the Recommended Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: 100 mg LY2940680 + C+ E', 'description': '100 mg LY2940680 administered orally once daily (QD) for 6 cycles.\n\n100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}, {'id': 'OG001', 'title': 'Phase 1b: 200 mg LY2940680 + C+ E', 'description': '200 mg LY2940680 administered orally once daily (QD) for 6 cycles.\n\n100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}, {'id': 'OG002', 'title': 'Phase 1b: 400 mg LY2940680 + C+ E', 'description': '400 mg LY2940680 administered orally once daily (QD) for 6 cycles.\n\n100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}], 'classes': [{'title': 'LY2940680 Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '2.05', 'groupId': 'OG000', 'lowerLimit': '1', 'upperLimit': '3.98'}, {'value': '2.01', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '2.05'}, {'value': '1.51', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '6'}]}]}, {'title': 'LY2940680 Cycle 2, Day 1', 'categories': [{'measurements': [{'value': '2.96', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '5.83'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1.88', 'upperLimit': '4.08'}, {'value': '1', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '6'}]}]}, {'title': 'LSN3185556 Cycle 1, Day 2', 'categories': [{'measurements': [{'value': '6.14', 'groupId': 'OG000', 'lowerLimit': '2', 'upperLimit': '24.03'}, {'value': '5.87', 'groupId': 'OG001', 'lowerLimit': '2.07', 'upperLimit': '24.97'}, {'value': '6', 'groupId': 'OG002', 'lowerLimit': '2.05', 'upperLimit': '24'}]}]}, {'title': 'LSN3185556 Cycle 2, Day 2', 'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '4'}, {'value': '4.08', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '23.83'}, {'value': '2.21', 'groupId': 'OG002', 'lowerLimit': '0.5', 'upperLimit': '6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours', 'unitOfMeasure': 'Hour (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped.'}, {'type': 'SECONDARY', 'title': 'Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of Carboplatin and Etoposide at the Recommended Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Phase 1b: LY2940680 + C+ E', 'description': 'LY2940680 administered orally once daily (QD) for 6 cycles.\n\n100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 (mg\\*min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.'}], 'classes': [{'title': 'Total Carboplatin Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '1.08'}]}]}, {'title': 'Total Carboplatin Cycle 2, Day 1', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.42', 'upperLimit': '1.05'}]}]}, {'title': 'Etoposide Cycle 1, Day 1', 'categories': [{'measurements': [{'value': '0.96', 'groupId': 'OG000', 'lowerLimit': '0.48', 'upperLimit': '1.5'}]}]}, {'title': 'Etoposide Cycle 2 ,Day 1', 'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.33', 'upperLimit': '1.17'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours', 'unitOfMeasure': 'Hour (h)', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of study drug and were enrolled in phase 1b study. Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. C and E doses did not change for the 3 cohorts of LY (100,200 and 400 mg) so we only need to report one grouping.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Phase 1b: 100 mg LY2940680 + C + E', 'description': '100 milligrams (mg) LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve (AUC) 5 milligrams\\*minute\\*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.\n\nMaintenance:\n\nSingle-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.'}, {'id': 'FG001', 'title': 'Phase 1b: 200 mg LY2940680 + C + E', 'description': '200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve (AUC) 5 milligrams\\*minute\\*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.\n\nMaintenance:\n\nSingle-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.'}, {'id': 'FG002', 'title': 'Phase 1B: 400 mg LY2940680 + C + E', 'description': '400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve (AUC) 5 milligrams\\*minute\\*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.\n\nMaintenance:\n\nSingle-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'Received at Least One Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Due to strategic reasons, the Phase 2 portion was not initiated, and further clinical development was stopped. Phase 1b study completer was defined as completion of the dose-limiting toxicity (DLT) period (1 cycle- 21 days cycle for LY2940680 in combination with carboplatin and etoposide.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Phase 1b: 100 mg LY2940680 + C +E', 'description': '100 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 milligrams\\*minute\\*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.\n\nMaintenance:\n\nSingle-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.'}, {'id': 'BG001', 'title': 'Phase 1b: 200 mg LY2940680 + C + E', 'description': '200 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 milligrams\\*minute\\*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.\n\nMaintenance:\n\nSingle-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.'}, {'id': 'BG002', 'title': 'Phase 1b: 400 mg LY2940680 + C + E', 'description': '400 mg LY2940680 administered orally once daily (QD) for 6 cycles. 100 mg per square meter (mg/m\\^2) etoposide (E) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle.\n\nArea under the Curve \\[AUC\\] 5 milligrams\\*minute\\*milliliters (mg•min/mL) carboplatin (C) administered by IV infusion on day 1 each cycle.\n\nMaintenance:\n\nSingle-agent LY2940680 administered orally QD at the same dose as induction at Cycles 7+ (21 day cycles). Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.3', 'spread': '9.35', 'groupId': 'BG000'}, {'value': '64.8', 'spread': '11.96', 'groupId': 'BG001'}, {'value': '60.2', 'spread': '12.19', 'groupId': 'BG002'}, {'value': '62.2', 'spread': '11.33', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '25', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, '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'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants who received at least one dose of study drug.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'whyStopped': 'Change in clinical strategy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'dispFirstSubmitDate': '2015-05-08', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-06', 'studyFirstSubmitDate': '2012-11-02', 'dispFirstSubmitQcDate': '2015-05-08', 'resultsFirstSubmitDate': '2018-10-16', 'studyFirstSubmitQcDate': '2012-11-02', 'dispFirstPostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-06', 'studyFirstPostDateStruct': {'date': '2012-11-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1b: Recommended Phase 2 Dose of LY2940680: Maximum Tolerated Dose (MTD)', 'timeFrame': 'Baseline to Completion of the Phase 1b (Up To 12 Months)', 'description': 'MTD was defined as the highest tested dose that has \\<33% probability of causing a dose-limiting toxicity(DLT). DLT was defined as an AE during Cycle 1 that is possibly related to the study drug and fulfills any one of the following criterion using the National Cancer Institute(NCI) Common Terminology Criteria for Adverse Events(CTCAE),version 4.0:Grade 3 non-hematological toxicity except nausea, vomiting, constipation, diarrhea, fatigue, or anorexia that is manageable with appropriate care,transient(i.e., ≤5 days) Grade 3 elevations of alanine aminotransferase(ALT) and/or aspartate aminotransferase(AST), without evidence of other hepatic injury, in the setting of preexisting hepatic metastasis, ≥Grade 3 thrombocytopenia with bleeding or Grade 4 thrombocytopenia of any duration,CTCAE Grade 4 hematological toxicity of \\>5 days duration and any febrile neutropenia. any other significant toxicity deemed by the primary investigator and Lilly clinical research personnel to be dose-limiting.'}, {'measure': 'Phase 2: Progression-Free Survival', 'timeFrame': 'Randomization to Measured Progressive Disease or Death of Any Cause (Estimated as 18 Months)'}], 'secondaryOutcomes': [{'measure': 'Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2940680, LSN3185556 at the Recommended Dose', 'timeFrame': 'Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours'}, {'measure': 'Phase 1b and 2: Pharmacokinetics (PK): Maximum Concentration (Cmax) of Carboplatin and Etoposide at the Recommended Dose', 'timeFrame': 'Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours'}, {'measure': 'Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for LY2940680 and LSN3185556 at the Recommended Dose', 'timeFrame': 'Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours'}, {'measure': 'Phase 1b and 2: Pharmacokinetics: Area Under the Curve ( AUC₀-₂₄) for Etoposide and as AUC₀-₆ for Carboplatin at the Recommended Dose', 'timeFrame': 'Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours'}, {'measure': 'Phase 1b: Percentage of Participants With Complete Response (CR) or Partial Response (PR) (Overall Response Rate [ORR])', 'timeFrame': 'Baseline to Study Completion Up to 39 Months', 'description': 'ORR was defined as the percentage of all randomized participants with the best overall response of PR or CR using Response Evaluation Criteria in Solid Tumors (RECIST v1.1). CR is the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \\<10 mm. Tumor marker results must have normalized. PR is at least a 30% decrease in the sum of diameter of target lesions, taking as reference the baseline sum diameters.'}, {'measure': 'Phase 1b: Percentage Inhibition of Expression Levels of Gli1 in Skin Cells', 'timeFrame': 'Baseline, Cycle 2 Day 1, Cycle 7 Day 1', 'description': 'The gene expression data (Gli1) was normalized and the level of percentage of Gli1 inhibition post treatment was calculated.'}, {'measure': 'Phase 2: Overall Survival', 'timeFrame': 'Randomization to Study Completion (Estimated as 38 Months)'}, {'measure': 'Phase 2: Percent Change in Tumor Size (CTS)', 'timeFrame': 'Randomization to End of Cycle 2 (Estimated as 24 Months)'}, {'measure': 'Phase 2: Number of Participants With a Complete or Partial Tumor Response (Overall Response Rate)', 'timeFrame': 'Randomization to Study Completion (Estimated as 38 Months)'}, {'measure': 'Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of LY2940680 andLSN3185556 at the Recommended Dose', 'timeFrame': 'Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours'}, {'measure': 'Phase 1b and 2: Pharmacokinetics: Time to Maximal Concentration (Tmax) of Carboplatin and Etoposide at the Recommended Dose', 'timeFrame': 'Cycle (C)1 Day (D) 1:Predose,0.5 ,1, 2, 4, 6, 8h; C2 D1:Pr,0.5,1,2,4,6,8 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Small Cell Lung Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find a recommended dose of LY2940680 that can be safely given in combination with etoposide and carboplatin followed by LY2940680 alone in participants with extensive-disease small cell lung cancer. The study will also compare progression-free survival in participants who are administered etoposide, carboplatin and LY2940680 followed by LY2940680 alone versus etoposide, carboplatin, and placebo followed by placebo alone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histological or cytological diagnosis of Small Cell Lung Cancer (SCLC), including malignant pleural effusion that is extensive stage per the International Staging System\n* Performance status of 0 to 1 on the Eastern Cooperative Oncology Group (ECOG) performance status schedule\n* No prior systemic chemotherapy, immunotherapy, or biological therapy for SCLC\n* Prior radiation therapy allowed to \\<25% of the bone marrow. Participants who have received prior radiation to the whole pelvis or chest for the treatment of SCLC are not eligible\n* At least 1 unidimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1\n* Adequate organ function including the following:\n\n * Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥1.5 x 10\\^9/ liter (L), platelets ≥100 x 10\\^9/L, and hemoglobin ≥9 grams/deciliter (g/dL)\n * Hepatic: bilirubin ≤1.5 times the upper limit of normal (ULN), alkaline phosphatase (AP), Serum alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤3.0 x ULN (AP, AST, and ALT ≤5 x ULN is acceptable if liver has tumor involvement)\n * Renal: calculated creatinine clearance (CrCl) ≥50 milliliters per minute (mL/min) based on the standard Cockcroft and Gault formula\n* Estimated life expectancy of at least 12 weeks\n* For women: Must be surgically sterile, post-menopausal, or compliant with a medically approved contraceptive regimen during and for 6 months after the treatment period; must have a negative serum pregnancy test within 7 days before study enrollment. For men: Must be surgically sterile or compliant with a contraceptive regimen during and for 6 months after the treatment period\n* Availability of a tumor tissue sample\n* Able to swallow capsules\n\nExclusion Criteria:\n\n* Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study\n* Have previously participated in a study involving LY2940680\n* Have previously received treatment with carboplatin or etoposide\n* Have a mixed histological diagnosis of SCLC and Non-Small Cell Lung Cancer (NSCLC)\n* Have a serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the participant's ability to adhere to the protocol\n* Have an active infection \\[≥38.5 degrees Celsius and/or receiving Intravenous (IV) antibiotic therapy\\]\n* Have a serious cardiac condition\n* Have had a prior malignancy other than SCLC, carcinoma in situ of the cervix, or nonmelanoma skin cancer, unless that prior malignancy was diagnosed and definitively treated at least 5 years previously with no subsequent evidence of recurrence. Participants with a history of non-metastatic prostate cancer, including biochemical relapse only, will be eligible even if diagnosed less than 5 years previously\n* Symptomatic central nervous system (CNS) metastases and asymptomatic CNS metastases requiring concurrent corticosteroid therapy. Treated stable CNS metastases are allowed; the participant must be stable after radiotherapy for ≥2 weeks and off of corticosteroids for ≥1 week\n* Presence of clinically significant third-space fluid collections that cannot be controlled prior to study entry\n* Significant weight loss (that is, ≥10%) over the 6-week period prior to study entry\n* Concurrent administration of any other antitumor therapy. An exception will be made for non-metastatic prostate cancer participants continuing androgen blockade therapy only or breast cancer participants continuing adjuvant antiestrogen therapy only (for example, an aromatase inhibitor)\n* Females who are breastfeeding\n* Have corrected QT interval (QTc) of \\>470 millisecond (msec) on screening electrocardiogram (ECG)\n* Have received medications that are strong inhibitors of Cytochrome P450 3A4 (CYP3A4) within 7 days prior to receiving study drug"}, 'identificationModule': {'nctId': 'NCT01722292', 'briefTitle': 'A Study of LY2940680 in Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 1b/2 Double-Blind Randomized Trial of the Hedgehog/SMO Antagonist LY2940680 in Combination With Carboplatin and Etoposide Followed by LY2940680 Versus Carboplatin and Etoposide Plus Placebo Followed by Placebo in Patients With Extensive-Stage Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '14631'}, 'secondaryIdInfos': [{'id': 'I4J-MC-HHBE', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2012-003174-83', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1b: LY2940680 + C + E', 'description': 'Phase 1b Dose Escalation: Cycles 1-6 (21 day cycles) LY2940680 administered orally, once daily at escalating doses (100 milligrams \\[mg\\] up to 400 mg) in combination with etoposide (E) 100 milligram per square meter (mg/m\\^2) administered by intravenous (IV) infusion on days 1, 2, 3 of each cycle and carboplatin (C) Area Under the Curve \\[AUC\\] 5 (mg•min/mL) administered by IV infusion on day 1 each cycle.\n\nPhase 1b Maintenance: Cycles 7+ (21 day cycles) LY2940680 administered orally, once daily at the same dose as induction. Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.', 'interventionNames': ['Drug: LY2940680', 'Drug: Carboplatin', 'Drug: Etoposide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Phase 2: Placebo + C + E', 'description': 'Induction: Cycles 1-6 (21 day cycles) Placebo administered orally once daily in combination with etoposide 100 mg/m2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle.\n\nMaintenance: Cycles 7+ (21 day cycles) Placebo administered orally once daily. Participants receiving benefit may continue until disease progression, unacceptable toxicity, or discontinuation.', 'interventionNames': ['Drug: Carboplatin', 'Drug: Etoposide', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: LY2940680 + C+ E', 'description': 'Induction: Cycles 1-6 (21 day cycles) LY2940680 (dose to be determined in Phase 1b portion) administered orally once daily in combination with etoposide 100 mg/m\\^2 administered by IV infusion on days 1, 2, 3 of each cycle and carboplatin AUC 5 administered by IV infusion on day 1 each cycle.\n\nMaintenance: Cycles 7+ (21 day cycles). LY2940680 (dose to be determined in Phase 1 portion) administered orally once daily.', 'interventionNames': ['Drug: LY2940680', 'Drug: Carboplatin', 'Drug: Etoposide']}], 'interventions': [{'name': 'LY2940680', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Phase 1b: LY2940680 + C + E', 'Phase 2: LY2940680 + C+ E']}, {'name': 'Carboplatin', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Phase 1b: LY2940680 + C + E', 'Phase 2: LY2940680 + C+ E', 'Phase 2: Placebo + C + E']}, {'name': 'Etoposide', 'type': 'DRUG', 'description': 'Administered IV', 'armGroupLabels': ['Phase 1b: LY2940680 + C + E', 'Phase 2: LY2940680 + C+ E', 'Phase 2: Placebo + C + E']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Administered orally', 'armGroupLabels': ['Phase 2: Placebo + C + E']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72703', 'city': 'Fayetteville', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Highlands Oncology Group', 'geoPoint': {'lat': 36.06258, 'lon': -94.15743}}, {'zip': '30607', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northeast Georgia Cancer Care, LLC', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}, {'zip': '89169', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Comprehensive Cancer Centers of Nevada', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '12206', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'New York Oncology Hematology Associate', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '29605', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Research Unit (ITOR) Greenville Hospital System', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '38119', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Accelerated Comm. Oncology Research Network (ACORN)', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'The West Clinic', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '77380', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'US Oncology', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}, {'zip': '75702', 'city': 'Tyler', 'state': 'Texas', 'country': 'United States', 'facility': 'Tyler Cancer Center', 'geoPoint': {'lat': 32.35126, 'lon': -95.30106}}, {'zip': '98684', 'city': 'Vancouver', 'state': 'Washington', 'country': 'United States', 'facility': 'Northwest Cancer Specialists PC', 'geoPoint': {'lat': 45.63873, 'lon': -122.66149}}, {'zip': '98902', 'city': 'Yakima', 'state': 'Washington', 'country': 'United States', 'facility': 'Yakima Valley Memorial Hospital', 'geoPoint': {'lat': 46.60207, 'lon': -120.5059}}, {'zip': 'SE1 9RT', 'city': 'London', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'M20 4BX', 'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}], 'overallOfficials': [{'name': 'Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eli Lilly and Company'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.\n\nThis access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}