Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Metastatic Non Small Cell Lung Cancer, sponsored by Eli Lilly and Company.
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 365-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (49% higher). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS is defined as the time from the date of randomization to the date of radiographically documented progressive disease (PD) based on investigator assessment, or the date of death due to any cause, whichever is first assessed via Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum mu
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 |
What the registry record for NCT02411448 still lists
NCT02411448 is an interventional study that assigns participants to a tested intervention. The registered 545 participants enrollment target is mid-sized for trials with a published cap, above the 365-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (49% higher).
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 names 20 study sites across 18 states, led by 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.
Learn More About Clinical Trials
Similar trials for Metastatic Non Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02411448's enrollment target sits among peer trials
545 9th of 31 higher than 23 of 31 other Metastatic Non Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Non Small Cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
RECRUITING · Phase 3
-
Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
RECRUITING · Phase 3
-
Study to Evaluate Efficacy and Safety of Firmonertinib Compared With Investigator's Choice of EGFR Inhibitor as First-Line Treatment in Participants Who Have Locally Advanced or Metastatic NSCLC With EGFR P-Loop and Alpha C-Helix Compressing (PACC) Uncommon Mutations
RECRUITING · Phase 3
-
A Study to Investigate the Efficacy and Safety of Dato-DXd With or Without Osimertinib Compared With Platinum Based Doublet Chemotherapy in Participants With EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
RECRUITING · Phase 3
-
LUNAR-2: TTFields With Pembrolizumab + Platinum-based Chemotherapy for Metastatic NSCLC
RECRUITING · Phase 3
-
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04553523 · 545 participants · NA
Hydrus® Microstent New Enrollment Post-Approval Study
- NCT03572374 · 546 participants · NA
Talking to Employers and Medical Staff About Breast Cancer Treatment and Your Job
- NCT05937685 · 546 participants · NA
Reducing Blood Pressure in Patients With High Cardiovascular Risk
- NCT06416150 · 546 participants · NA
Reducing Urban Cervical Cancer Disparities
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI