NCT02411448Active, not recruitingPhase 3
A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
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
Source: ClinicalTrials.gov · Last updated 6 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 545 (actual)
- First submitted
- 3 Apr 2015
- Start date
- 6 May 2015
- Primary completion date
- 23 Jan 2019
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Lung cancer
- NCT number
- NCT02411448
- EU CT number
- 2024-514269-20-00
- EudraCT number
- 2014-004824-22
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 545
- From 6 May 2015 to the primary completion date, 23 Jan 2019
- 101 sites in 14 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Ongoing treatment with CYP3A4 inducers or strong inhibitors.
- Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
- History of any arterial thrombotic event within 6 months prior to enrollment.
Other illness
- Serious illness or medical condition.
- History of gross hemoptysis.
- Significant bleeding disorders.
- Radiologically documented evidence of major blood vessel invasion or encasement by cancer.
- History of gastrointestinal perforation within last 6 months.
- History of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.
Lab values
- Known T790M EGFR mutation (not applicable for Part C Period 2).
Other
- Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases.
- Radiographic evidence of intratumor cavitation.
- The participant has any known significant ophthalmologic abnormalities of the surface of the eye.
Who the study is looking for
- Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 7th edition 2009).
- Eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating EGFR mutation \[exon 19 deletion or exon 21 (L858R) substitution mutation\].
- Mandatory provision of adequate archived stage IV NSCLC tissue samples or tissue samples other than stage IV NSCLC may be acceptable (optional for part C).
- At least one measurable lesion.
- Life expectancy of at least 3 months.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (101)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cross Cancer Institute Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Helios Klinikum Emil von Behring Berlin-Zehlendorf Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Klinikum Chemnitz GmbH Coordinator of this site? Confirm its status | Chemnitz | Germany | Unknown status |
| Klinikum Köln-Merheim Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| Robert-Bosch-Krankenhaus Coordinator of this site? Confirm its status | Gerlingen | Germany | Unknown status |
| LungenClinic Grosshansdorf Coordinator of this site? Confirm its status | Großhansdorf | Germany | Unknown status |
| Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH Coordinator of this site? Confirm its status | Halle | Germany | Unknown status |
| Thoraxklinik Heidelberg gGmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Unknown status |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Completed |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Completed |
| University Hospital Virgen Del Rocio S.L. Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Chu Grenoble Alpes Coordinator of this site? Confirm its status | La Tronche | France | Unknown status |
| Hopital Claude Huriez - CHU de Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Hôpital Arnaud de Villeneuve - CHU Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| Hôpital Européen Georges Pompidou Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| Centre Hospitalier Universitaire de Poitiers Coordinator of this site? Confirm its status | Poitiers | France | Unknown status |
| Charing Cross Hospital Coordinator of this site? Confirm its status | Chelsea | United Kingdom | Unknown status |
| Royal Marsden Hospital (Chelsea) Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| City Hospital, Nottingham University Hospitals Coordinator of this site? Confirm its status | Nottingham | United Kingdom | Unknown status |
| Sotiria Thoracic Diseases Hospital of Athens Coordinator of this site? Confirm its status | Athens | Greece | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Yau Ma Tei | Hong Kong SAR China | Unknown status |
| Cro-Irccs Coordinator of this site? Confirm its status | Aviano | Italy | Unknown status |
| Instituto Tumori Giovanni Paolo II Coordinator of this site? Confirm its status | Bari | Italy | Unknown status |
| IRCCS - AOU di Bologna Coordinator of this site? Confirm its status | Bologna | Italy | Unknown status |
| Ospedale San Raffaele Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Azienda Sanitaria Ospedaliera S Luigi Gonzaga Coordinator of this site? Confirm its status | Orbassano | Italy | Unknown status |
| Istituto Oncologico Veneto - IRCCS Coordinator of this site? Confirm its status | Padova | Italy | Unknown status |
| Hyogo Cancer Center Coordinator of this site? Confirm its status | Akashi | Japan | Unknown status |
| Hyogo Prefectual Amagasaki General Medical Center Coordinator of this site? Confirm its status | Amagashiki | Japan | Unknown status |
| National Hospital Organization Asahikawa Medical Center Coordinator of this site? Confirm its status | Asahikawa | Japan | Unknown status |
| Tokyo Met Cancer & Infectious Diseases Center Komagome Hp Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| Chiba University Hospital Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Unknown status |
| National Hospital Organization Kyushu Cancer Center Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Kyushu University Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| National Hospital Organization Kyushu Medical Center Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Osaka Habikino Medical Center Coordinator of this site? Confirm its status | Habikino | Japan | Unknown status |
| Himeji Medical Center Coordinator of this site? Confirm its status | Himeji | Japan | Unknown status |
| Kansai Medical University Hospital Coordinator of this site? Confirm its status | Hirakata | Japan | Unknown status |
| Saitama Prefectural Cancer Center Coordinator of this site? Confirm its status | Ina-machi | Japan | Unknown status |
| Kanazawa University Hospital Coordinator of this site? Confirm its status | Kanazawa | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa | Japan | Unknown status |
| Kishiwada City Hospital Coordinator of this site? Confirm its status | Kishiwada | Japan | Unknown status |
| Kobe City Medical Center General Hospital Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Foundation for Biomedical Research and innovation Coordinator of this site? Confirm its status | Kobe | Japan | Unknown status |
| Japanese Foundation for Cancer Research Coordinator of this site? Confirm its status | Koto | Japan | Unknown status |
| Kurume University Hospital Coordinator of this site? Confirm its status | Kurume | Japan | Unknown status |
| Kyoto University Hospital Coordinator of this site? Confirm its status | Kyoto | Japan | Unknown status |
| Nagasaki University Hospital Coordinator of this site? Confirm its status | Nagasaki | Japan | Unknown status |
| Aichi Cancer Center Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Unknown status |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Nakatogari | Japan | Unknown status |
| Niigata Cancer Center Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Niigata University Medical & Dental Hospital Coordinator of this site? Confirm its status | Niigata | Japan | Unknown status |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Unknown status |
| Osaka City University Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Osaka Medical Center for Cancer and Cardiovascular Diseases Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Osaka City General Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Kindai University Hospital- Osakasayama Campus Coordinator of this site? Confirm its status | Ōsaka-sayama | Japan | Unknown status |
| National Hospital Organization Kinki-Chuo Chest Medical Center Coordinator of this site? Confirm its status | Sakai | Japan | Unknown status |
| Sendai Kousei Hospital Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Juntendo University Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| St. Lukes International Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Nippon Medical School Hospital Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Ehime University Hospital Coordinator of this site? Confirm its status | Tōon | Japan | Unknown status |
| National Hospital Organization Yamaguchi Ube Medical Center Coordinator of this site? Confirm its status | Ube | Japan | Unknown status |
| Wakayama Medical University Hospital Coordinator of this site? Confirm its status | Wakayama | Japan | Unknown status |
| Kanagawa Cardiovascular and Respiratory Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Gyeongsang National University Hospital Coordinator of this site? Confirm its status | Jinju | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam | South Korea | Unknown status |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic Univ. of Korea Seoul St. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Institutul Oncologic Coordinator of this site? Confirm its status | Bucharest | Romania | Unknown status |
| S.C. MedisProf SRL Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Unknown status |
| E-DA Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Chang Gung Memorial Hospital at Kaohsiung Coordinator of this site? Confirm its status | Kaohsiung Niao Sung Dist | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| MacKay Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| St. Charles Health System Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Queens Medical Associates Coordinator of this site? Confirm its status | Fresh Meadows | United States | Unknown status |
| The Gastroenterology Group, P.C. Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| UCLA Hematology/Oncology - Santa Monica Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| AHN Allegheny General Hospital Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| Cancer Center of Kansas Coordinator of this site? Confirm its status | Wichita | United States | Unknown status |
| Baskent University Dr. Turgut Noyan Research and Training Center Coordinator of this site? Confirm its status | Adana | Turkey (Türkiye) | Unknown status |
| Ege Universitesi Hastanesi Coordinator of this site? Confirm its status | Bornova | Turkey (Türkiye) | Unknown status |
| Trakya University Coordinator of this site? Confirm its status | Edirne | Turkey (Türkiye) | Unknown status |
| İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi Coordinator of this site? Confirm its status | Malatya | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.