The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Brief Title: TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR-mutant/Metastatic NSCLC Who Have Not Had Any Previous EGFR Directed Therapy
Official Title: TIGER 1: A Randomized, Open-Label, Phase 2/3 Study of CO-1686 or Erlotinib as First-Line Treatment of Patients With EGFR-Mutant Advanced/Metastatic NSCLC
Study ID: NCT02186301
Brief Summary: The purpose of this study is to compare the safety and anti-tumor effect of rociletinib with erlotinib in patients whose tumors have specific EGFR mutations and who have not previously received any treatment for advanced/metastatic EGFR mutated NSCLC. This study is a 'Randomized' Study. This means that upon entering the study, patients will be randomly assigned to be dosed with either rociletinib twice a day or erlotinib once a day. Patients will continue to take either rociletinib or erlotinib until it is no longer beneficial.
Detailed Description: This is a randomized, Phase 2/3 study of rociletinib versus erlotinib as a first-line treatment for patients with EGFR-mutant advanced/metastatic NSCLC whose tumors have EGFR-activating mutations. The study will consist of Phase 2 and Phase 3 parts which will use the same enrollment criteria and treatment assignment principles. Patients will be randomized 1:1 to erlotinib or rociletinib. The Phase 2 part is an open-label study. In the Phase 3 part, the sponsor will be blinded to the efficacy and safety results. The study will consist of a screening phase to establish study eligibility (including tumor genotype) and document baseline measurements, a treatment phase, in which patients will receive either rociletinib BID (twice a day) or erlotinib QD (once daily) to ascertain safety and efficacy until protocol-defined disease progression, and a follow-up phase, to monitor survival status and subsequent NSCLC cancer therapy. In the Phase 2 part only, patients initially randomized to erlotinib may be eligible to participate in an optional crossover phase to receive rociletinib if they demonstrate the T790M resistance mutation after radiographic progression on erlotinib treatment among other eligibility requirements. Patients eligible for this study must have EGFR-mutated NSCLC who have not been treated with an EGFR-directed therapy.Treatment with rociletinib or erlotinib is continuous. Each 28 day period of treatment will represent one cycle, with dosing initiated on Cycle 1 Day 1 (C1 D1).
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Alabama at Birmingham, Birmingham, Alabama, United States
East Valley Hematology and Oncology Medical Group, Inc., Burbank, California, United States
City of Hope, Duarte, California, United States
Compassionate Cancer Care Medical Group, Inc., Fountain Valley, California, United States
St. Joseph Heritage Healthcare, Fullerton, California, United States
UC San Diego Moores Cancer Center, La Jolla, California, United States
University of Southern California, Norris Comprehensive Cancer Center, Los Angeles, California, United States
Sutter Medical Group, Sacramento, California, United States
University of California San Francisco, San Francisco, California, United States
Sansum Clinic, Santa Barbara, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
UCLA Medical Center, Santa Monica, California, United States
The Oncology Institute of Hope and Innovation, Whittier, California, United States
University of Colorado Cancer Center, Aurora, Colorado, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Cancer Specialists of North Florida, Fleming Island, Florida, United States
Florida Cancer Specialists and Research Institute, Fort Myers, Florida, United States
Advanced Medical Specialties, Miami, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Florida Cancer Specialists, Saint Petersburg, Florida, United States
Cleveland Clinic Florida, Weston, Florida, United States
Northwestern University, Chicago, Illinois, United States
University of Illinois Cancer Center, Chicago, Illinois, United States
Illinois Cancer Specialists, Niles, Illinois, United States
Harry and Jeanette Weinberg Cancer Institute at Franklin Square, Baltimore, Maryland, United States
Walter Reed Army Institute of Research, Bethesda, Maryland, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Oncology Hematology West PC, Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada, Henderson, Nevada, United States
Regional Cancer Care Associates, LLC, East Brunswick, New Jersey, United States
Regional Cancer Care Associates, Morristown, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Duke University Medical Center, Durham, North Carolina, United States
University of Cincinnati Medical Center, Cincinnati, Ohio, United States
University Hospitals Case Medical Center, Cleveland, Ohio, United States
Cleveland Clinic, Cleveland, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, United States
Hollings Cancer Center, Charleston, South Carolina, United States
Tennessee Oncology, PLLC, Chattanooga, Tennessee, United States
Tennessee Oncology, PLLC, Nashville, Tennessee, United States
USC/Norris Comprehensive Cancer Center, Nashville, Tennessee, United States
Texas Oncology, PA, Austin, Texas, United States
Texas Oncology-Beaumont, Beaumont, Texas, United States
Texas Oncology, P.A., Bedford, Texas, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Houston Methodist Cancer Center, Houston, Texas, United States
The University of Texas - MD Anderson Cancer Center, Houston, Texas, United States
Texas Oncology-Plano East, Plano, Texas, United States
Virginia Cancer Specialists, PC, Fairfax, Virginia, United States
University of Washington, Seattle, Washington, United States
Northwest Cancer Specialists, P.C., Vancouver, Washington, United States
Yakima Valley Memorial Hospital, North Star Lodge, Yakima, Washington, United States
Asklepios Fachkliniken München-Gauting, Gauting, Bayern, Germany
Pius Hospital Oldenburg, Oldenburg, Niedersachsen, Germany
Universitätsklinikum Köln, Köln, Nordrhein-Westfalen, Germany
Katholisches Klinikum Mainz, Sankt Hildegardis-Krankenhaus, Mainz, Rheinland-Pfalz, Germany
Evangelische Lungenklinik Berlin, Berlin, , Germany
Prince of Wales Hospital, Hong Kong, New Territories, Hong Kong
Queen Mary Hospital, Hong Kong, , Hong Kong
Ospedale Civile di Livorno, Livorno, , Italy
Dong-A University Hospital, Busan, , Korea, Republic of
Inha University Hospital, Incheon, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Severance Hospital, Yonsei University Health System, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea Saint Vincent's Hospital, Suwon, , Korea, Republic of
Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Taichung Veterans General Hospital, Taichung, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital Linkou, Taoyuan, , Taiwan