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A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
Sponsor: Eli Lilly and Company
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
545
Start Date
2015-05-06
Completion Date
2026-12
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
Ramucirumab
Administered IV.
Placebo
Administered IV.
Erlotinib
Administered orally.
Gefitinib
Administered orally.
Osimertinib
Administered orally.
Locations (106)
UCLA Hematology/Oncology - Santa Monica
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-Wurttemberg, Germany
Thoraxklinik Heidelberg gGmbH
Heidelberg, Baden-Wurttemberg, Germany
Klinikum Köln-Merheim
Cologne, North Rhine-Westphalia, Germany
Klinikum Chemnitz GmbH
Chemnitz, Saxony, Germany
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
Halle, Saxony-Anhalt, 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
Instituto Tumori Giovanni Paolo II
Bari, Apulia, Italy
Cro-Irccs
Aviano, Friuli Venezia Giulia, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano, Torino, Italy
IRCCS - AOU di Bologna
Bologna, Italy
Ospedale San Raffaele
Milan, Italy
Istituto Oncologico Veneto IRCCS
Padova, Italy
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Ehime University Hospital
Tōon, Ehime, Japan
Kurume University Hospital
Kurume, Fukuoka, Japan
National Hospital Organization Asahikawa Medical Center
Asahikawa, Hokkaido, Japan
Hyogo Cancer Center
Akashi, Hyōgo, Japan
Hyogo Prefectual Amagasaki General Medical Center
Amagashiki, Hyōgo, Japan
Himeji Medical Center
Himeji, Hyōgo, Japan
Foundation for Biomedical Research and innovation
Kobe, Hyōgo, Japan
Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 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, 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- Osakasayama Campus
Ōsaka-sayama, Osaka, Japan
National Hospital Organization Kinki-Chuo Chest Medical Center
Sakai, Osaka, Japan
Saitama Prefectural Cancer Center
Ina-machi, Saitama, Japan
Shizuoka Cancer Center
Nakatogari, 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
Institutul Oncologic
Bucharest, București, Romania
S.C. MedisProf SRL
Cluj-Napoca, Cluj, Romania
Chungbuk National University Hospital
Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea
Seoul National University Bundang Hospital
Seongnam, Kyǒnggi-do, South Korea
The Catholic University Of Korea St. Vincent's Hospital
Suwon, Kyǒnggi-do, South Korea
Ajou University Hospital
Suwon, Kyǒnggi-do, South Korea
Gyeongsang National University Hospital
Jinju, Kyǒngsangnam-do, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Korea University Guro Hospital
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Ulsan University Hospital
Ulsan, Ulsan-Kwangyǒkshi, South Korea
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 Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid, Comunidad de, Spain
Clinica Universitaria De Navarra
Pamplona, Navarre, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Hospital Universitario Virgen de Valme
Seville, 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 City, 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 (Türkiye)
Baskent University Dr. Turgut Noyan Research and Training Center
Adana, Turkey (Türkiye)
Trakya University
Edirne, Turkey (Türkiye)
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
Malatya, Turkey (Türkiye)
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