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
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
The main purpose of this study is to evaluate the efficacy and safety of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in previously untreated participants with stage IV non-small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Exon 19-Del and Exon 21 L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in Part A before proceeding to 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.
Inclusion Criteria:
Exclusion Criteria:
Amagashiki, Hyōgo 660-8550, Japan
Ina-machi, Saitama 362-0806, Japan
Bunkyo-ku, Tokyo 113-8677, Japan
Chuo-Ku, Tokyo 104-0045, Japan
Koto, Tokyo 135-8550, Japan
Seoul, Seoul-teukbyeolsi [Seoul] 06591, South Korea
Hospitalet, Barcelona [Barcelona] 08908, Spain
Kaohsiung Niao Sung Dist, Kaohsiung 83301, Taiwan
Malatya, 44280, Turkey (Türkiye)