Efficacy and safety of finotonlimab plus docetaxel <i>vs.</i> docetaxel in previously treated advanced squamous cell non-small-cell lung cancer: a randomized, double-blinded, phase III trial.

ABSTRACT:

Background

Lung cancer is the most common cancer in the world, and non-small cell lung cancer (NSCLC) constitutes about 80-85%. In this phase III trial, we evaluate the efficacy and safety of anti-programmed cell death-1 (PD-1) monoclonal antibody (SCT-I10A) plus docetaxel compared to docetaxel in patients with previously treated advanced squamous cell NSCLC (sqNSCLC).

Methods

Patients were randomized 2:1 to finotonlimab plus docetaxel group (finotonlimab plus docetaxel) and docetaxel group (placebo plus docetaxel) for up to 6 cycles, followed by maintenance monotherapy with finotonlimab/placebo. The primary endpoint was overall survival (OS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), duration of response (DoR), progression-free

SUBMITTER: Han B 

PROVIDER: S-EPMC12082229 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature