Study LUN17-139 looked at the side effects and effectiveness of Atezolizumab (A) plus Carboplatin (C) plus Pemetrexed (Pem) plus Bevacizumab (B) (ACBPem) in patients with stage IV non-squamous non-small cell lung cancer (Ns-NSCLC) who had never had any prior treatment for their disease. In this multicenter, single-arm stage II preliminary, all patients got A (1200-mg, D1) + C (AUC 5, D1) + Pem (500-mg/m2, D1) + B (15-mg/kg D1) q3 week x4. If there is no PD (progressive disease), patients get ABPem until PD or unfortunate aftereffects. The essential endpoint was progression-free survival (PFS). The positive PFS result was considered PFS greater than 6m (verifiable control).
Optional endpoints included the objective reaction rate (ORR), infectious disease control rate (DCR) characterized by complete response (CR) + partial response (PR) + stable disease (SD) lasting more than equal to 2 months, overall survival (OS), and wellbeing. About 30 patients were enrolled from November 2018 to October 2020. Unfortunately, the review was shut right on time because of 3 patient passings, perhaps connected with treatment. Middle age 64 (range 38-83); Men/Ladies 20/10; PD-L1 TPS < 1%/1-49%/≥ half (8/15/7). The middle follow-up was 20.3 months (1-28.1). ORR 42.9% (95% CI, 24.5-62.8%), DCR 96.4% (95% CI, 81.7-99.9%). The middle PFS and OS were 11.3m (5.5-14.9, P>.05) and 22.4m (22.4-NR), respectively.
About 4 patients had G4 harmfulness (iron deficiency, febrile-neutropenia, extreme neutropenia, sepsis), and 3 patients had G5 poisonousness (thromboembolism, sepsis, colonic perforation).s, ABCPem was related to longer PFS compared to historical controls, but the difference did not reach statistical significance. Thromboembolic events involving 5 patients and 3 deaths while receiving treatment caused the early termination of care.