Besse B, Barlesi F, Demedts I, et al. - In patients with advanced non-small cell lung cancer (NSCLC) already managed with ≤ 2 lines of chemotherapy, including a platinum-based one, whether necitumumab plus abemaciclib would be safe and effective was investigated in this 2-part, single-arm, multicenter, phase 1b trial. The study enrolled 66 patients, including 71% male, 41% squamous histology, 15% never-smokers. The maximum tolerated dose of abemaciclib, in Part A (n = 15), was 150 mg Q12H in combination with necitumumab 800 mg. The 3-month progression-free survival (PFS) rate and median PFS were 32.3% and 2.14 months, respectively, in 57 patients treated at this dose level. The overall response rate and the median OS were estimated to be 5.3% and 6.93 months, respectively. Fatigue (14%), dyspnea (9%), diarrhea (7%), vomiting (7%), and hypokalemia (7%) were documented as the most commonly experienced grade 3 treatment-emergent adverse events. Findings revealed no additive effect of abemaciclib 150 mg Q12H with necitumumab 800 mg over single-agent activity in patients with stage IV NSCLC. The observed safety profile was compatible with individual study drugs.