A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Metastatic Non-Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT02411448
- Run by
- Eli Lilly and Company
- People needed
- 545
- Starts
- 2015-05-06
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Known T790M EGFR mutation (not applicable for Part C Period 2).
- Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases.
- Serious illness or medical condition.
- Ongoing treatment with CYP3A4 inducers or strong inhibitors.
- Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.
- History of gross hemoptysis.
- Significant bleeding disorders.
- Radiologically documented evidence of major blood vessel invasion or encasement by cancer.
- Radiographic evidence of intratumor cavitation.
- History of gastrointestinal perforation within last 6 months.
- History of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.
- History of any arterial thrombotic event within 6 months prior to enrollment.
- The participant has any known significant ophthalmologic abnormalities of the surface of the eye.
Where it is running
- 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
- UCLA Hematology/Oncology - Santa Monica — Los Angeles, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.