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Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): A randomised, double-blind, placebo-controlled, phase 3 trial

The Lancet Oncology Oct 14, 2019

Nakagawa K, Garon EB, Seto T, et al. - Among patients with untreated EGFR-mutated metastatic non-small-cell lung cancer (NSCLC) enrolled in this worldwide, double-blind, phase 3 trial (RELAY), researchers evaluated the therapeutic efficacy of erlotinib (an EGFR tyrosine kinase inhibitor standard of care) plus ramucirumab (a human IgG1 VEGFR2 antagonist) or placebo. This investigation was conducted in 100 hospitals, clinics, and medical centres in 13 countries. Random allocation 1:1 of eligible patients was done to receive oral erlotinib (150 mg/day) plus either intravenous ramucirumab (10 mg/kg) or matching placebo once every 2 weeks. In the intention-to-treat population, investigator-evaluated progression-free survival was considered as the primary endpoint. Findings revealed superior progression-free survival in relation to treatment with ramucirumab plus erlotinib vs placebo plus erlotinib in patients with untreated EGFR-mutated metastatic NSCLC. The observed safety was consistent with the safety profiles of the individual compounds in advanced lung cancer. In the ramucirumab plus erlotinib group vs the placebo plus erlotinib group, 159 (72%) of 221 patients vs 121 (54%) of 225, respectively, suffered grade 3–4 treatment-emergent adverse events. For the initial treatment of EGFR-mutated metastatic NSCLC, the RELAY regimen affords a viable novel treatment option.
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