Besse B, Barlesi F, Demedts I, et al. - In this 2-part, single-arm, multicenter, phase 1b trial including patients with advanced non-small cell lung cancer (NSCLC) who had taken ≤ 2 lines of chemotherapy, including a platinum-based one, researchers assessed the safety and effectiveness of necitumumab (an anti-EGFR antibody) plus abemaciclib (a CDK4/6 inhibitor). Researchers conducted a dose-escalation phase (Part A) for abemaciclib (100, 150, 200 mg, Q12 H) in combination with necitumumab 800 mg D1D8 Q3W to define the recommended dose for the expansion cohort Part B. Progression-free survival rate at 3 months was assessed as the primary endpoint. The study sample included 66 patients, with 71% male, 41% squamous histology, 15% never-smokers. The maximum tolerated dose of abemaciclib determined in Part A was 150 mg Q12H in combination with necitumumab 800 mg. In patients with stage IV NSCLC, findings revealed no additive effect of abemaciclib 150 mg Q12H with necitumumab 800 mg vs activity seen with a single agent. A safety profile consistent with the individual study drugs was seen.