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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

Full criteria on ClinicalTrials.gov

Sites (101)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cross Cancer Institute
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EdmontonCanadaUnknown status
Helios Klinikum Emil von Behring Berlin-Zehlendorf
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BerlinGermanyUnknown status
Klinikum Chemnitz GmbH
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ChemnitzGermanyUnknown status
Klinikum Köln-Merheim
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CologneGermanyUnknown status
Robert-Bosch-Krankenhaus
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GerlingenGermanyUnknown status
LungenClinic Grosshansdorf
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GroßhansdorfGermanyUnknown status
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
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HalleGermanyUnknown status
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyUnknown status
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Chu Grenoble Alpes
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La TroncheFranceUnknown status
Hopital Claude Huriez - CHU de Lille
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LilleFranceUnknown status
Hôpital Arnaud de Villeneuve - CHU Montpellier
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MontpellierFranceUnknown status
Hôpital Européen Georges Pompidou
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ParisFranceUnknown status
Centre Hospitalier Universitaire de Poitiers
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PoitiersFranceUnknown status
Charing Cross Hospital
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ChelseaUnited KingdomUnknown status
Royal Marsden Hospital (Chelsea)
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LondonUnited KingdomUnknown status
City Hospital, Nottingham University Hospitals
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NottinghamUnited KingdomUnknown status
Sotiria Thoracic Diseases Hospital of Athens
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AthensGreeceUnknown status
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Queen Elizabeth Hospital
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Yau Ma TeiHong Kong SAR ChinaUnknown status
Cro-Irccs
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AvianoItalyUnknown status
Instituto Tumori Giovanni Paolo II
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BariItalyUnknown status
IRCCS - AOU di Bologna
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BolognaItalyUnknown status
Ospedale San Raffaele
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MilanItalyUnknown status
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
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OrbassanoItalyUnknown status
Istituto Oncologico Veneto - IRCCS
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PadovaItalyUnknown status
Hyogo Cancer Center
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AkashiJapanUnknown status
Hyogo Prefectual Amagasaki General Medical Center
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AmagashikiJapanUnknown status
National Hospital Organization Asahikawa Medical Center
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AsahikawaJapanUnknown status
Tokyo Met Cancer & Infectious Diseases Center Komagome Hp
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Bunkyo-kuJapanUnknown status
Chiba University Hospital
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ChibaJapanUnknown status
National Cancer Center Hospital
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Chuo KuJapanUnknown status
National Hospital Organization Kyushu Cancer Center
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FukuokaJapanUnknown status
Kyushu University Hospital
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FukuokaJapanUnknown status
National Hospital Organization Kyushu Medical Center
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FukuokaJapanUnknown status
Osaka Habikino Medical Center
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HabikinoJapanUnknown status
Himeji Medical Center
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HimejiJapanUnknown status
Kansai Medical University Hospital
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HirakataJapanUnknown status
Saitama Prefectural Cancer Center
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Ina-machiJapanUnknown status
Kanazawa University Hospital
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KanazawaJapanUnknown status
National Cancer Center Hospital East
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KashiwaJapanUnknown status
Kishiwada City Hospital
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KishiwadaJapanUnknown status
Kobe City Medical Center General Hospital
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KobeJapanUnknown status
Foundation for Biomedical Research and innovation
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KobeJapanUnknown status
Japanese Foundation for Cancer Research
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KotoJapanUnknown status
Kurume University Hospital
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KurumeJapanUnknown status
Kyoto University Hospital
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KyotoJapanUnknown status
Nagasaki University Hospital
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NagasakiJapanUnknown status
Aichi Cancer Center Hospital
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NagoyaJapanUnknown status
Shizuoka Cancer Center
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NakatogariJapanUnknown status
Niigata Cancer Center Hospital
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NiigataJapanUnknown status
Niigata University Medical & Dental Hospital
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NiigataJapanUnknown status
Okayama University Hospital
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OkayamaJapanUnknown status
Osaka City University Hospital
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OsakaJapanUnknown status
Osaka Medical Center for Cancer and Cardiovascular Diseases
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OsakaJapanUnknown status
Osaka City General Hospital
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OsakaJapanUnknown status
Kindai University Hospital- Osakasayama Campus
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Ōsaka-sayamaJapanUnknown status
National Hospital Organization Kinki-Chuo Chest Medical Center
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SakaiJapanUnknown status
Sendai Kousei Hospital
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SendaiJapanUnknown status
Juntendo University Hospital
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TokyoJapanUnknown status
St. Lukes International Hospital
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TokyoJapanUnknown status
Nippon Medical School Hospital
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TokyoJapanUnknown status
Ehime University Hospital
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TōonJapanUnknown status
National Hospital Organization Yamaguchi Ube Medical Center
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UbeJapanUnknown status
Wakayama Medical University Hospital
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WakayamaJapanUnknown status
Kanagawa Cardiovascular and Respiratory Center
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YokohamaJapanUnknown status
Kanagawa Cancer Center
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YokohamaJapanUnknown status
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
Gyeongsang National University Hospital
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JinjuSouth KoreaUnknown status
Seoul National University Bundang Hospital
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SeongnamSouth KoreaUnknown status
Korea University Guro Hospital
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SeoulSouth KoreaUnknown status
The Catholic Univ. of Korea Seoul St. Mary's Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
The Catholic University of Korea St. Vincent's Hospital
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SuwonSouth KoreaUnknown status
Ajou University Hospital
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SuwonSouth KoreaUnknown status
Ulsan University Hospital
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UlsanSouth KoreaUnknown status
Institutul Oncologic
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BucharestRomaniaUnknown status
S.C. MedisProf SRL
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Cluj-NapocaRomaniaUnknown status
E-DA Hospital
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Kaohsiung CityTaiwanUnknown status
Chang Gung Memorial Hospital at Kaohsiung
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Kaohsiung Niao Sung DistTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
MacKay Memorial Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Levine Cancer Institute
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CharlotteUnited StatesUnknown status
St. Charles Health System
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DenverUnited StatesUnknown status
Queens Medical Associates
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Fresh MeadowsUnited StatesUnknown status
The Gastroenterology Group, P.C.
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HonoluluUnited StatesUnknown status
UCLA Hematology/Oncology - Santa Monica
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Los AngelesUnited StatesUnknown status
AHN Allegheny General Hospital
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PittsburghUnited StatesUnknown status
Cancer Center of Kansas
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WichitaUnited StatesUnknown status
Baskent University Dr. Turgut Noyan Research and Training Center
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AdanaTurkey (Türkiye)Unknown status
Ege Universitesi Hastanesi
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BornovaTurkey (Türkiye)Unknown status
Trakya University
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EdirneTurkey (Türkiye)Unknown status
İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
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MalatyaTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.