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Brief Title: A Study of Carboplatin and Paclitaxel With or Without MEDI-575 in Untreated, Advanced Non-Small Cell Lung Cancer
Official Title: A Phase 1b/2 Randomized Study of MEDI-575 in Combination With Carboplatin Plus Paclitaxel Versus Carboplatin Plus Paclitaxel Alone in Adult Subjects With Previously Untreated, Advanced Non-Small Cell Lung Cancer
Study ID: NCT01268059
Brief Summary: The purpose of this study is to evaluate the dose, antitumor activity, safety and pharmacology of MEDI-575 in combination with carboplatin/paclitaxel in subjects with previously untreated, advanced non-small cell lung cancer (NSCLC).
Detailed Description: This is a Phase 1b/2, multicenter, open-label study of MEDI-575 to evaluate the dose, anti-tumor activity, safety, and pharmacology (pharmacokinetics, immunogenicity, and biomarkers) of MEDI-575 in combination with carboplatin/paclitaxel in subjects with previously untreated, advanced non-small cell lung cancer. This study has two phases: dose determination (Phase 1b) and randomization (Phase 2).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Fountain Valley, California, United States
Research Site, Oxnard, California, United States
Research Site, Chicago, Illinois, United States
Research Site, Lafayette, Indiana, United States
Research Site, Baton Rouge, Louisiana, United States
Research Site, Annapolis, Maryland, United States
Research Site, Baltimore, Maryland, United States
Research Site, Baltimore, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Danvers, Massachusetts, United States
Research Site, Detroit, Michigan, United States
Research Site, Omaha, Nebraska, United States
Research Site, Lake Success, New York, United States
Research Site, Canton, Ohio, United States
Research Site, Hershey, Pennsylvania, United States
Research Site, Hilton Head Island, South Carolina, United States
Research Site, Chattanooga, Tennessee, United States
Research Site, Corpus Christi, Texas, United States
Research Site, Houston, Texas, United States
Research Site, Ottawa, Ontario, Canada
Research Site, Marseille cedex, , France
Research Site, Berlin, , Germany
Research Site, Szombathely, , Hungary
Research Site, Fukuoka-shi, , Japan
Research Site, Sunto-gun, , Japan
Research Site, Gdansk, , Poland
Research Site, Lodz, , Poland
Research Site, Mrozy, , Poland
Research Site, Szczecin, , Poland
Name: MedImmune LLC
Affiliation: MedImmune LLC
Role: STUDY_DIRECTOR