Completed Enrollment

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)

I4T-MC-JVCY -

The main purpose of this study is to evaluate the safety and efficacy of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in participants with stage IV non small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (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 participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.

Trial Summary

Age Range
≥18 years
Conditions the trial is for
Non-Small Cell Lung Cancer
What the trial is testing?
Ramucirumab, Erlotinib
Could I receive a Placebo?
Yes
Enrollment Goal
545
Trial Dates
May 6, 2015 - Dec 2024
How long will I be in the trial?
You can participate in this study for as long as your study doctor determines is appropriate.
Trial Phase
III

Key Requirements

Clinical trials have inclusion and exclusion requirements to determine which individuals qualify for participation. Listed below are key requirements for this clinical trial, but there may be additional requirements to qualify.

Participants Must:

  • Participant must have diagnosis of stage IV NSCLC

  • Participant must have documented evidence of a tumor with an activating EGFR mutation and be eligible for first-line treatment with erlotinib

  • Participant must be able to provide adequate archived stage IV NSCLC tissue sample or tissue samples other than stage IV NSCLC may be acceptable (optional for part C)

  • Participant must have ECOG performance status of 0 or 1 where 0 = Fully active, able to carry on all pre-disease performance without restriction and 1 = Restricted in physically strenuous activity but able to walk and carry out light work, e.g., light house work, office work

  • Participant must have one measurable lesion

Participants Must Not:

  • Participant must not have a known T790M mutation

  • Participant must not have brain metastases

  • Participant must not have a history of significant bleeding disorders or blood clots in the arteries

  • Participant must not have any known significant abnormalities of the surface of the eye

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