Last updated on February 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Metastatic Non-Small Cell Lung Cancer | Metastatic Non Small Cell Lung Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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