Efficacy and safety of nanoparticle albumin-bound paclitaxel monotherapy after immune checkpoint inhibitor administration for advanced non-small cell lung cancer: A multicenter Phase 2 clinical trial

This Phase 2 study evaluated the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) in advanced non-small cell lung cancer (NSCLC) patients after programmed cell death 1 or programmed death ligand 1 (PD-(L)1) inhibitor failure. Twenty-nine patients received nab-paclitaxel (100 mg/m²). The objective response rate (ORR) was 55.2% (95% CI: 28.1%-79.6%), and the disease control rate (DCR) was 86.2% (95% CI: 65.9%-97.0%). Median progression-free survival (PFS) was 5.6 months (95% CI: 4.4-6.7 months), and median overall survival (OS) was 11.9 months (95% CI: 0.8-23.0 months). Grade 3 or higher toxicities were observed, primarily hematologic. Good performance status and response to prior PD-(L)1 inhibitor therapy predicted longer PFS.

Tomoaki Sonoda, Yukihiro Umeda, Yoshiki Demura, Toshihiko Tada, Koki Nakashima, Masaki Anzai, Makiko Yamaguchi, Akikazu Shimada, Masahiro Ohi, Chisato Honjo, Yuko Waseda, Masaya Akai, Tamotsu Ishizuka