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

Study ID
STU 112016-046

Study Sites

  • Parkland Health & Hospital System

Contact
Jessica Saltarski
214/648-1688
jessica.Saltarski@utsouthwestern.edu

Principal Investigator
Saad Khan, M.D.

Official Title

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

Brief Overview

The main purpose of this study is to evaluate the safety and efficacy of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in participants with stage IV non small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B).

Eligibility

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 (Example 19 del and L858R).
- Mandatory provision of adequate archived stage IV NSCLC tissue samples or tissue samples other than stage IV NSCLC may be acceptable.
- At least one measurable lesion.
- Life expectancy of at least 3 months.
Exclusion Criteria:
- 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 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.