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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Eli Lilly and Company
Study ID
NCT02411448
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Metastatic Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ramucirumab — DRUG
    Administered IV.
  • Placebo — DRUG
    Administered IV.
  • Erlotinib — DRUG
    Administered orally.
  • Gefitinib — DRUG
    Administered orally.
  • Osimertinib — DRUG
    Administered orally.

Study Details

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 Dates

Start date
May 6, 2015
Status verified
Dec 2025
Primary completion
Jan 23, 2019
Completion
Dec 31, 2026

Study Design

Enrollment
545 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ramucirumab + Erlotinib
    Part A: 10 milligrams per kilogram (mg/kg) ramucirumab administered every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. Part B: 10 mg/kg ramucirumab administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
  • Placebo Comparator: Placebo + Erlotinib
    Part B: Placebo administered every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met.
  • Experimental: Ramucirumab + Gefitinib or Osimertinib
    Part C: 10 mg/kg ramucirumab administered every 2 weeks intravenously (IV) + 250 mg Gefitinib or 80 mg Osimertinib daily orally. * Ramucirumab and gefitinib administered during period 1. * Ramucirumab and osimertinib administered during period 2.

Primary Outcome Measure

Part B: Progression Free Survival (PFS) [ Time Frame: Randomization to Measured Progressive Disease or Death from Any Cause (Up To 37 Months) ]

Locations (7)

FacilityCityStateZIPSite coordinators
UCLA Hematology/Oncology - Santa MonicaLos AngelesCalifornia90404-
St. Charles Health SystemDenverColorado80203-
The Gastroenterology Group, P.C.HonoluluHawaii96813-
Cancer Center of KansasWichitaKansas67214-
Queens Medical AssociatesFresh MeadowsNew York11366-
Levine Cancer InstituteCharlotteNorth Carolina28204-
AHN Allegheny General HospitalPittsburghPennsylvania15212-

Find similar trials in Los Angeles, CA

By research site
UCLA Hematology/Oncology - Santa Monica· Los Angeles, CASt. Charles Health System· Denver, COThe Gastroenterology Group, P.C.· Honolulu, HICancer Center of Kansas· Wichita, KSQueens Medical Associates· Fresh Meadows, NYLevine Cancer Institute· Charlotte, NC

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