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Brief Title: LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations
Official Title: LUX Lung 2 A Phase II Single-arm Trial of BIBW 2992 in Non-small Cell Lung Cancer Patients With EGFR Activating Mutations
Study ID: NCT00525148
Brief Summary: The primary objective of this open-label, single arm Phase II trial is to explore the efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by RECIST criteria in patients with advanced NSCLC Stage IIIB or IV whose tumors harbor activating mutations within exon 18 to exon 21 of the EGFR receptor. Patients progressing or relapsing after one prior cytotoxic chemotherapy regimen as well as chemotherapy naïve patients (only in stage 2) will be allowed to enter into the trial.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
1200.22.28 Boehringer Ingelheim Investigational Site, Bakersfield, California, United States
1200.22.32 Boehringer Ingelheim Investigational Site, Beverly Hills, California, United States
1200.22.4 Boehringer Ingelheim Investigational Site, Mission Hills, California, United States
1200.22.16 Boehringer Ingelheim Investigational Site, Orange, California, United States
1200.22.19 Boehringer Ingelheim Investigational Site, Fort Lauderdale, Florida, United States
1200.22.29 Boehringer Ingelheim Investigational Site, North Miami Beach, Florida, United States
1200.22.10 Boehringer Ingelheim Investigational Site, Atlanta, Georgia, United States
1200.22.18 Boehringer Ingelheim Investigational Site, Chicago, Illinois, United States
1200.22.3 Boehringer Ingelheim Investigational Site, Bethesda, Maryland, United States
1200.22.14 Boehringer Ingelheim Investigational Site, Boston, Massachusetts, United States
1200.22.24 Boehringer Ingelheim Investigational Site, Flint, Michigan, United States
1200.22.5 Boehringer Ingelheim Investigational Site, Minneapolis, Minnesota, United States
1200.22.15 Boehringer Ingelheim Investigational Site, New York, New York, United States
1200.22.26 Boehringer Ingelheim Investigational Site, New York, New York, United States
1200.22.1 Boehringer Ingelheim Investigational Site, Rochester, New York, United States
1200.22.27 Boehringer Ingelheim Investigational Site, Syracuse, New York, United States
1200.22.25 Boehringer Ingelheim Investigational Site, Valhalla, New York, United States
1200.22.6 Boehringer Ingelheim Investigational Site, Canton, Ohio, United States
1200.22.7 Boehringer Ingelheim Investigational Site, Wynnewood, Pennsylvania, United States
1200.22.22 Boehringer Ingelheim Investigational Site, Mt. Pleasant, South Carolina, United States
1200.22.31 Boehringer Ingelheim Investigational Site, Fairfax, Virginia, United States
1200.22.40 Boehringer Ingelheim Investigational Site, Renton, Washington, United States
1200.22.33 Boehringer Ingelheim Investigational Site, Seattle, Washington, United States
1200.22.88604 Taichung Veterans General Hospital, Taichung, , Taiwan
1200.22.88605 China Medical University Hospital, Taichung, , Taiwan
1200.22.88606 Boehringer Ingelheim Investigational Site, Tainan, , Taiwan
1200.22.88607 Boehringer Ingelheim Investigational Site, Taipei City, , Taiwan
1200.22.88601 National Taiwan University Hospital, Taipei, , Taiwan
1200.22.88602 Veterans General Hospital, Taipei, , Taiwan
1200.22.88603 Chang Gung Memorial Hosp-Linkou, Taoyuan, , Taiwan
Name: Boehringer Ingelheim
Affiliation: Boehringer Ingelheim
Role: STUDY_CHAIR