Spots Global Cancer Trial Database for A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
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Trial Identification
Brief Title: A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
Official Title: A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination With Ramucirumab or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer
Study ID: NCT02411448
Conditions
Study Description
Brief Summary: The main purpose of this study is to evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Exon 19-Del and Exon 21 L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in Part A before proceeding to Part B. The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
UCLA Hematology/Oncology - Santa Monica, Los Angeles, California, United States
TRIO-US (Translational Research in Oncology-US), Los Angeles, California, United States
St. Charles Health System, Denver, Colorado, United States
The Gastroenterology Group, P.C., Honolulu, Hawaii, United States
Cancer Center of Kansas, Wichita, Kansas, United States
Queens Medical Associates, Fresh Meadows, New York, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
AHN Allegheny General Hospital, Pittsburgh, Pennsylvania, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
Hôpital Arnaud de Villeneuve - CHU Montpellier, Montpellier, Hérault, France
Chu Grenoble Alpes, La Tronche, Isère, France
Hopital Claude Huriez - CHU de Lille, Lille, Nord, France
Centre Hospitalier Universitaire de Poitiers, Poitiers, Vienne, France
Hôpital Européen Georges Pompidou, Paris, , France
Robert-Bosch-Krankenhaus, Gerlingen, Baden-Württemberg, Germany
Thoraxklinik Heidelberg gGmbH, Heidelberg, Baden-Württemberg, Germany
Klinikum Köln-Merheim, Köln, Nordrhein-Westfalen, Germany
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH, Halle (Saale), Sachsen-Anhalt, Germany
Klinikum Chemnitz GmbH, Chemnitz, Sachsen, Germany
LungenClinic Grosshansdorf, Großhansdorf, Schleswig-Holstein, Germany
Helios Klinikum Emil von Behring Berlin-Zehlendorf, Berlin, , Germany
Sotiria Thoracic Diseases Hospital of Athens, Athens, Attikí, Greece
Queen Mary Hospital, Hong Kong, , Hong Kong
Queen Elizabeth Hospital, Yau Ma Tei, , Hong Kong
Cro-Irccs, Aviano, Friuli-Venezia Giulia, Italy
Instituto Tumori Giovanni Paolo II, Bari, Puglia, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga, Orbassano, Torino, Italy
IRCCS - AOU di Bologna, Bologna, , Italy
Ospedale San Raffaele, Milano, , Italy
Istituto Oncologico Veneto IRCCS, Padova, , Italy
Aichi Cancer Center Hospital, Nagoya, Aichi, Japan
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Ehime University Hospital, Toon, Ehime, Japan
Kurume University Hospital, Kurume, Fukuoka, Japan
National Hospital Organization Asahikawa Medical Center, Asahikawa, Hokkaido, Japan
Hyogo Cancer Center, Akashi, Hyogo, Japan
Hyogo Prefectual Amagasaki General Medical Center, Amagashiki, Hyogo, Japan
Himeji Medical Center, Himeji, Hyogo, Japan
Foundation for Biomedical Research and innovation, Kobe, Hyogo, Japan
Kobe City Medical Center General Hospital, Kobe, Hyogo, Japan
Kanazawa University Hospital, Kanazawa, Ishikawa, Japan
Kanagawa Cardiovascular and Respiratory Center, Yokohama, Kanagawa, Japan
Kanagawa Cancer Center, Yokohama, Kanagawa, Japan
Sendai Kousei Hospital, Sendai, Miyagi, Japan
Niigata Cancer Center Hospital, Niigata-shi, Niigata, Japan
Osaka Habikino Medical Center, Habikino, Osaka, Japan
Kansai Medical University Hospital, Hirakata, Osaka, Japan
Kishiwada City Hospital, Kishiwada, Osaka, Japan
Kindai University Hospital, Osaka-Sayama, Osaka, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Osaka, Japan
Saitama Prefectural Cancer Center, Ina-machi, Saitama, Japan
Tominaga Hospital, Nagaizumi, Shizuoka, Japan
Tokyo Met Cancer & Infectious Diseases Center Komagome Hp, Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital, Chuo-Ku, Tokyo, Japan
Japanese Foundation for Cancer Research, Koto, Tokyo, Japan
National Hospital Organization Yamaguchi Ube Medical Center, Ube, Yamaguchi, Japan
Chiba University Hospital, Chiba, , Japan
National Hospital Organization Kyushu Medical Center, Fukuoka, , Japan
National Hospital Organization Kyushu Cancer Center, Fukuoka, , Japan
Kyushu University Hospital, Fukuoka, , Japan
Kyoto University Hospital, Kyoto, , Japan
Nagasaki University Hospital, Nagasaki, , Japan
Niigata University Medical & Dental Hospital, Niigata, , Japan
Okayama University Hospital, Okayama, , Japan
Osaka City General Hospital, Osaka, , Japan
Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka, , Japan
Osaka City University Hospital, Osaka, , Japan
St. Lukes International Hospital, Tokyo, , Japan
Juntendo University Hospital, Tokyo, , Japan
Nippon Medical School Hospital, Tokyo, , Japan
Wakayama MedicaL University Hospital, Wakayama, , Japan
Chungbuk National University Hospital, Cheongju-si, Chungcheongbuk-do [Chungbuk], Korea, Republic of
Seoul National University Bundang Hospital, Seongnam, Kyǒnggi-do, Korea, Republic of
The Catholic University Of Korea St. Vincent's Hospital, Suwon-si, Kyǒnggi-do, Korea, Republic of
Ajou University Hospital, Suwon-si, Kyǒnggi-do, Korea, Republic of
Gyeongsang National University Hospital, Jin-ju-si, Kyǒngsangnam-do, Korea, Republic of
Asan Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Korea University Guro Hospital, Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Ulsan University Hospital, Ulsan, Ulsan-Kwangyǒkshi, Korea, Republic of
Institutul Oncologic, Bucuresti, București, Romania
S.C. MedisProf SRL, Cluj-Napoca, Cluj, Romania
Hospital Universitari Vall d'Hebron, Barcelona, Barcelona [Barcelona], Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals, Hospitalet, Barcelona [Barcelona], Spain
Hospital Son Llatzer, Palma, Illes Balears [Islas Baleares], Spain
Hospital Universitario 12 de Octubre, Madrid, Madrid, Comunidad De, Spain
Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcon, Madrid, Spain
Clinica Universitaria De Navarra, Pamplona, Navarra, Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Universitario Nuestra Señora de Valme, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Chang Gung Memorial Hospital at Kaohsiung, Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
E-DA Hospital, Kaohsiung, , Taiwan
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
MacKay Memorial Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Ege Universitesi Hastanesi, Bornova, İzmir, Turkey
Baskent University Dr. Turgut Noyan Research and Training Center, Adana, , Turkey
Trakya University, Edirne, , Turkey
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi, Malatya, , Turkey
Royal Marsden Hospital (Chelsea), London, Kensington And Chelsea, United Kingdom
Charing Cross Hospital, Chelsea, London, United Kingdom
City Hospital, Nottingham University Hospitals, Nottingham, Nottinghamshire, United Kingdom
Contact Details
Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Affiliation: Eli Lilly and Company
Role: STUDY_DIRECTOR
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