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). The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.
Name: Ramucirumab
Description: Administered IV.Type: DrugRamucirumab + Erlotinib (Part C) Ramucirumab + Gefitinib or Osimertinib
Name: Placebo
Description: Administered IV.Type: DrugPlacebo + Erlotinib
Name: Erlotinib
Description: Administered orally.Type: DrugRamucirumab + Erlotinib Placebo + Erlotinib
Name: Gefitinib
Description: Administered orally.Type: Drug(Part C) Ramucirumab + Gefitinib or Osimertinib
Name: Osimertinib
Description: Administered orally.Type: Drug(Part C) Ramucirumab + Gefitinib or Osimertinib
Allocation: Randomized
Parallel Assignment
There are 2 SNPs
A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC 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). --- L858R ---
- 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]. --- L858R ---
The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC. --- T790M ---
Exclusion Criteria: - Known T790M EGFR mutation (not applicable for Part C Period 2). --- T790M ---