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NCT02411448 · ClinicalTrials.gov registry record · Phase 3
A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
A Phase 3 study of Metastatic Non Small Cell Lung Cancer, sponsored by Eli Lilly and Company.
- Active
- Registry status
- Phase 3
- Development phase
- 545
- Enrollment target
- 20
- Study locations
NCT02411448 is a Phase 3 study of Metastatic Non Small Cell Lung Cancer that is active but no longer recruiting, run by Eli Lilly and Company. The registered enrollment target is 545 participants, above the 376-participant average among 30 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (45% higher). The trial reports 20 study locations across 18 states.
The verdict
NCT02411448, a Phase 3 study of Metastatic Non Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Eli Lilly and Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 545 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Osimertinib
- DRUG Ramucirumab
- DRUG Gefitinib
- DRUG Erlotinib
Study Locations (20)
Other
- Hôpital Européen Georges Pompidou - Paris
- Helios Klinikum Emil von Behring Berlin-Zehlendorf - Berlin
Baden-Wurttemberg
- Robert-Bosch-Krankenhaus - Gerlingen
- Thoraxklinik Heidelberg gGmbH - Heidelberg
California
- UCLA Hematology/Oncology - Santa Monica - Los Angeles
Colorado
- St. Charles Health System - Denver
Hawaii
- The Gastroenterology Group, P.C. - Honolulu
Kansas
- Cancer Center of Kansas - Wichita
New York
- Queens Medical Associates - Fresh Meadows
North Carolina
- Levine Cancer Institute - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 545 participants |
| Start Date | 2015-05-06 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02411448
The ClinicalTrials.gov registry entry for NCT02411448 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 545 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 376-participant average among 30 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (45% higher). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Metastatic Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT02411448 reports 20 study locations spanning 18 distinct geographic areas - top geographies include Other, Baden-Wurttemberg, California.
Frequently Asked Questions
What is clinical trial NCT02411448 about?
NCT02411448 is a clinical study titled "A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)". 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 facto...
What is the current status of trial NCT02411448?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 545 participants. The study started on 2015-05-06. Estimated completion is 2026-12.
What conditions does trial NCT02411448 study?
This clinical trial studies the following conditions: Metastatic Non Small Cell Lung Cancer.
What interventions are being tested in trial NCT02411448?
The interventions under investigation include: Placebo (DRUG), Osimertinib (DRUG), Ramucirumab (DRUG), Gefitinib (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT02411448?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02411448 being conducted?
This trial has 20 study locations across California, Colorado, Hawaii, Kansas, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.