Spots Global Cancer Trial Database for Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene
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Trial Identification
Brief Title: Study of Erlotinib (Tarceva®) in Combination With OSI-906 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene
Official Title: A Randomized, Double-Blind, Phase 2 Study of Erlotinib (Tarceva®) in Combination With OSI-906 or Placebo in Chemonaive Patients With Advanced NSCLC With Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene
Study ID: NCT01221077
Study Description
Brief Summary: A multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Erlotinib (Tarceva®) in combination with OSI-906 in Patients with Advanced non-small cell lung cancer (NSCLC) with Activating Mutations of the Epidermal Growth Factor Receptor (EGFR) Gene who are Chemonaive.
Detailed Description: Based on the recommendation of the Data Monitoring Committee, OSI-906 and matching placebo are no longer being administered as of 01 March 2013. This is a multi-center, randomized (1:1), double-blind, placebo-controlled, phase 2 study. Patients will be stratified according to the following 2 parameters: (1) EGFR activating mutation type (exon 19 deletion versus exon 21 single point mutation); and (2) Eastern Cooperative Oncology Group (ECOG) performance status (0 vs. 1).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of California, San Diego/Moores Cancer Center, La Jolla, California, United States
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
Cleveland Clinic Florida, Weston, Florida, United States
Northwestern Memorial Hospital, Chicago, Illinois, United States
Rush University Medical Center, Chicago, Illinois, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States
Karmanos Cancer Institute, Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Medical University of South Carolina, Charleston, South Carolina, United States
University of Tennessee Cancer Institute, Memphis, Tennessee, United States
Vanderbilt University Medical Center, Nashville, Tennessee, United States
Swedish Cancer Institute, Seattle, Washington, United States
Seattle Cancer Care Alliance University of Washington, Seattle, Washington, United States
Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Jewish General Hospital, Montreal, Quebec, Canada
Pamela Youde Nethersole Eastern Hospital, Chai Wan, , Hong Kong
Chonnam National University Hwasun Hospital, Ilsimri, Hwasun-gun, Korea, Republic of
Asan Medical Center, Songpa-gu, Seoul, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Oncocare Cancer Center, Singapore, , Singapore
Johns Hopkins Singapore International Medical Centre, Singapore, , Singapore
National Cancer Institute, Phayathai, Bangkok, Thailand
Maharaj Nakorn Chiangmai, Chiang Mai, , Thailand
Khon Kaen University, Khon Kaen, , Thailand
Songklanagarind Hospital, Prince of Songkla University, Songkla, , Thailand
Contact Details
Name: Medical Director
Affiliation: Astellas Pharma Global Development
Role: STUDY_DIRECTOR
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