- 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
- Eligible for first-line treatment with erlotinib based on documented evidence of
tumor harboring an activating EGFR mutation (Example 19 del and L858R).
- Mandatory provision of adequate archived stage IV NSCLC tissue sample.
- At least one measurable lesion.
- Life expectancy of at least 3 months.
- Known T790M EGFR mutation.
- Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression,
or brain metastases.
- Serious illness or medical condition.
- Ongoing treatment with CYP3A4 inducers or strong/moderate 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
- Radiographic evidence of intratumor cavitation.
- History of gastrointestinal perforation within last 6 months.
- History of bowel obstruction, inflammatory enteropathy or extensive intestinal
- 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.
Minimum Eligible Age: 18 Years
Maximum Eligible Age: N/A
Eligible Gender: Both
Overall Survival (OS)
Objective Response Rate (ORR)
Disease Control Rate (DCR)
Duration of Response (DoR)
Pharmacokinetics (PK): Minimum Concentration (CMIN) of Ramucirumab
Number of Participants with Anti-Ramucirumab Antibodies
Change from Baseline on the Lung Cancer Symptom Scale (LCSS)
Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L)