Journal of Clinical OncologyPhase II Randomized Study of Ramucirumab and Pembrolizumab Versus Standard of Care in Advanced Non–Small-Cell Lung Cancer Previously Treated With Immunotherapy—Lung-MAP S1800A

Immune checkpoint inhibitor (ICI)-refractory cancers are arguably one of the greatest unmet needs in oncology. In this randomized phase II substudy, patients ineligible for a biomarker-matched previously treated with ICI and platinum-based chemotherapy and progressive disease at least 84 days after initiation of ICI were randomly assigned to receive ramucirumab plus pembrolizumab (RP) or investigator’s choice standard of care (SOC: docetaxel/ramucirumab, docetaxel, gemcitabine, and pemetrexed). The study’s primary objective was to compare overall survival (OS). The median OS was 14.5 months for RP and 11.6 months for SOC. Docetaxel and ramucirumab were the most common SOC, received by 2/3 of patients. This randomized phase II trial demonstrated significantly improved OS with RP compared with SOC in patients with advanced NSCLC previously treated with ICI and chemotherapy.