VEGF Receptor-2 Antagonist
Not Enrolling
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*

NCT02411448 show modal icon
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.
For information on trial enrollment, locations, and more, call 1-800-545-5979.