RELAY; NCT02411448


VEGF Receptor-2 Antagonist

A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination With Ramucirumab or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Metastatic Non-small Cell Lung Cancer*

show modal icon NCT02411448
Key Inclusion Criteria
  • Stage IV non-small cell lung cancer (NSCLC)
  • Eligible for first-line treatment with erlotinib
  • Documented evidence of a tumor harboring an activating epidermal growth factor receptor (EGFR) mutation (defined as exon 19 deletion or exon 21 [L858R] substitution)
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • At least one measurable lesion
  • Life expectancy of ≥3 months
Key Exclusion Criteria
  • 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 cytochrome P450 3A4 (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 the 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
  • Known significant ophthalmologic abnormalities of the surface of the eye
This clinical trial is being conducted globally.
The phase 1b portion of this study is complete.
Ramucirumab 10 mg/kg or placebo equivalent is administered intravenously Q2W.
Erlotinib 150 mg is administered PO QD.
Gefitinib is administered PO.
Osimertinib is administered PO.
Contact the Lilly Oncology Clinical Trial Navigation Service

Visit for more information on this trial.

Need additional information or have a question:

The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.