Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2025-12-28 @ 3:39 PM
Study NCT ID:
NCT00034268
Status:
COMPLETED
Last Update Posted:
2006-07-19
First Post:
2002-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer
Sponsor:
Organization:
Raw JSON
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If treatment with LY900003 plus gemcitabine and cisplatin can help you live longer, compared with gemcitabine and cisplatin alone.\n2. The safety of LY900003 plus gemcitabine and cisplatin and any side effects that might be associated with the combination of these three drugs.\n3. Whether LY900003 plus gemcitabine and cisplatin can make your tumor smaller or disappear, and for how long, compared with gemcitabine and cisplatin alone.\n\nIt is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate LY900003 plus gemcitabine and cisplatin for other possible uses or for other medical or scientific purposes other than those currently proposed.\n\nLY900003 may not add any benefit to gemcitabine plus cisplatin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Stage IIIB or IV non-small lung cancer\n2. Able to visit the doctor's office\n3. At least 18 years of age\n4. Adequate kidney, adrenal, and liver function\n\nExclusion Criteria:\n\n1. Prior chemotherapy or biologic therapy for NSCLC\n2. Central nervous system tumors\n3. Pregnant or breastfeeding"}, 'identificationModule': {'nctId': 'NCT00034268', 'briefTitle': 'A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase 3 Trial of LY900003 Plus Gemcitabine and Cisplatin Versus Gemcitabine and Cisplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '6428'}, 'secondaryIdInfos': [{'id': 'H7X-MC-JVAA'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'LY900003', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hot Springs', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 34.5037, 'lon': -93.05518}}, {'city': 'Springdale', 'state': 'Arkansas', 'country': 'United States', 'geoPoint': {'lat': 36.18674, 'lon': -94.12881}}, {'city': 'Los Angeles', 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