VEGF Receptor-2 Antagonist
Ramucirumab
Phase
3
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*
Related Resources:
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.
