Spots Global Cancer Trial Database for TIGER-3: Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy
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Trial Identification
Brief Title: TIGER-3: Open Label, Multicenter Study of Rociletinib (CO-1686) Mono Therapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR NSCLC Who Have Failed at Least One Previous EGFR-Directed TKI and Platinum-doublet Chemotherapy
Official Title: TIGER-3: A Phase 3, Open-label, Multicenter, Randomized Study of Oral Rociletinib (CO-1686) Monotherapy Versus Single-agent Cytotoxic Chemotherapy in Patients With Mutant EGFR Non-small Cell Lung Cancer (NSCLC) After Failure of at Least 1 Previous EGFR-directed Tyrosine Kinase Inhibitor (TKI) and Platinum-doublet Chemotherapy
Study ID: NCT02322281
Conditions
Study Description
Brief Summary: The purpose of this study is to compare the anti-tumor efficacy of oral single-agent rociletinib, as measured by investigator assessment of the PFS, with that of single-agent cytotoxic chemotherapy in patients with EGFR-mutated, advanced/metastatic NSCLC after failure of at least 1 previous EGFR-directed TKI and at least 1 line of platinum-containing doublet chemotherapy.
Detailed Description: This is a Phase 3, randomized, open-label, multicenter study evaluating the safety and efficacy of oral rociletinib at 500 mg BID and 625 mg BID compared with that of single-agent cytotoxic chemotherapy, in patients with previously treated mutant EGFR NSCLC. Eligible patients are those with mutant EGFR NSCLC previously treated with at least 1 EGFR inhibitor and at least 1 line of platinum-containing chemotherapy doublet for advanced/metastatic NSCLC. After providing informed consent to participate and screening to confirm eligibility, patients will be randomized 1:1:1 to receive either oral rociletinib 500 mg BID, oral rociletinib 625 mg BID, or single-agent cytotoxic chemotherapy (investigator choice of pemetrexed, gemcitabine, docetaxel, or paclitaxel; choice of chemotherapy agent must be specified before randomization).
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Comprehensive Blood and Cancer Center, Bakersfield, California, United States
City of Hope Cancer Center, Duarte, California, United States
Saint Joseph Heritage Healthcare, Fullerton, California, United States
University of California San Diego Moores Cancer Center, La Jolla, California, United States
Cancer Care Associates Medical Group, Inc., Redondo Beach, California, United States
Sutter Cancer Center, Sacramento, California, United States
University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, California, United States
Central Coast Medical Oncology Corporation, Santa Maria, California, United States
University of California at Los Angeles, Santa Monica, California, United States
Stanford University School of Medicine, Stanford, California, United States
The Oncology Institute of Hope and Innovation, Whittier, California, United States
Sylvester Comprehensive Cancer Center (UMHC), Deerfield Beach, Florida, United States
University of Florida Health Science Center, Gainesville, Florida, United States
Memorial Healthcare System, Pembroke Pines, Florida, United States
Northside Hospital, Atlanta, Georgia, United States
North Shore University Health System, Evanston, Illinois, United States
Walter Reed National Military Medical Center, Bethesda, Maryland, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
Barbara Ann Karmanos Cancer Institute, Detroit, Michigan, United States
Virginia Piper Cancer Institute, Minneapolis, Minnesota, United States
Regional Cancer Care Associates, LLC, East Brunswick, New Jersey, United States
Regional Cancer Care Associates, Morristown, New Jersey, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
The Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
Providence Health and Services, Portland, Oregon, United States
Oregon Health & Science University (OHSU) - Knight Cancer Institute, Portland, Oregon, United States
University of Pittsburgh Cancer Institute (UPMC), Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Huntsman Cancer Institute, Salt Lake City, Utah, United States
University of Virginia, Charlottesville, Virginia, United States
Virginia Cancer Institute, Richmond, Virginia, United States
Royal North Shore Hospital, Saint Leonards, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Flinders Medical Centre, Bedford Park, South Australia, Australia
Hopital Hautepierre (CHU) de Strasbourg, Strasbourg, Alsace, France
Centre François Baclesse, Caen, Basse-Normandie, France
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou, Rennes, Bretagne, France
Centre Hospitalier Intercommunal Créteil, Créteil, Ile-de-France, France
Hôpital Bichat-Claude Bernard, Paris, Ile-de-France, France
CHRU de Limoges - Hôpital Dupuytren, Limoges, Limousin, France
CHRU de Lille - Hôpital Calmette, Lille, Nord Pas-de-Calais, France
L'Assistance Publique - Hopitaux de Marseille, Marseille, Provence Alpes Cote D'Azur, France
Centre Léon Bérard, Lyon, , France
Asklepios Fachkliniken München-Gauting, Gauting, Baden-Wuerttemberg, Germany
Thoraxklinik Heidelberg gGmbH, Heidelberg, Baden-Wuerttemberg, Germany
LMU - Klinikum der Universität München, München, Bayern, Germany
Pius Hospital Oldenburg, Oldenburg, Niedersachen, Germany
Johannes-Wesling-Klinikum Minden, Minden, Nordrhein-westfalen, Germany
LungenClinic Großhansdorf GmbH, Großhansdorf, Schleswig-Holstein, Germany
A.O.U. San Luigi Gonzaga di Orbassano, Orbassano, Torino, Italy
Azienda Ospedaliero-Universitaria Careggi, Firenze, , Italy
IRCCS Azienda Ospedaliera Universitaria San Martino - IST, Genova, , Italy
Ospedale Civile di Livorno, Livorno, , Italy
Istituto Europeo di Oncologia, Milano, , Italy
Azienda Ospedaliera di Perugia, Perugia, , Italy
Chungbuk National University Hospital, Cheongju-si, Cheungcheongbuk-do, Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea Saint Vincent's Hospital, Suwon, Gyeonggi, Korea, Republic of
Chonnam National University Hwasun Hospital, Hwasun-gun, Jeollanam-do, Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Academisch Ziekenhuis Maastricht, Maastricht, Limburg, Netherlands
Antoni van Leeuwenhoek Hospital, Amsterdam, Noord-Holland, Netherlands
Universitair Medisch Centrum Groningen, Groningen, , Netherlands
Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain
Hospital de Mataró, Mataró, Barcelona, Spain
Institut Universitari Dexeus, Barcelona, , Spain
Hospital Universitari Vall D'Hebron, Barcelona, , Spain
Fundacion Jimenez Diaz (Clinica de la Concepcion) (UAM -FJD), Madrid, , Spain
Hospital Regional Universitario Carlos Haya, Málaga, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Cheng-Kung University Hospital, Tainan, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
University College London Hospitals, London, England, United Kingdom
Guy's and Saint Thomas NHS Foundation Trust, London, England, United Kingdom
Royal Marsden NHS Trust, London, England, United Kingdom
The Christie NHS Foundation Trust, Manchester, England, United Kingdom
Contact Details
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