A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
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Keep this study
Lead
Eli Lilly and Company
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Previously Untreated Participants With EGFR Mutation-Positive Metastatic NSCLC (RELAY)
