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

Inclusion Criteria

• Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 7th edition 2009).
• Eligible for first-line treatment with erlotinib based on documented evidence of tumor harboring an activating EGFR mutation [exon 19 deletion or exon 21 (L858R) substitution mutation].
• Mandatory provision of adequate archived stage IV NSCLC tissue samples or tissue samples other than stage IV NSCLC may be acceptable (optional for part C).
• At least one measurable lesion.
• Life expectancy of at least 3 months.

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 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 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.
• The participant has any known significant ophthalmologic abnormalities of the surface of the eye.