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ACTIVE NOT RECRUITING
NCT02411448
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Ramucirumab

Administered IV.

DRUG

Placebo

Administered IV.

DRUG

Erlotinib

Administered orally.

DRUG

Gefitinib

Administered orally.

DRUG

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