3D MEDICINES (01244) announced that the Phase III clinical trial for ENVISTAR® (generic name: Envafolimab Injection, R&D code: KN035), co-developed with Alphamab Oncology (stock code: 9966.HK), has completed patient enrollment ahead of schedule. This randomized, controlled, double-blind, multicenter Phase III study (trial number: KN035-CN-017) is evaluating ENVISTAR® for the neoadjuvant/adjuvant treatment of patients with resectable non-small cell lung cancer (NSCLC).

The trial, led by Principal Investigator Professor Changli Wang from Tianjin Medical University Cancer Institute and Hospital, was conducted across approximately 60 clinical research centers nationwide. It planned to enroll about 390 patients with resectable Stage III NSCLC. The actual enrollment has met the requirements of the study protocol and was completed ahead of the original schedule.

The primary objective of this study is to evaluate the efficacy and safety of ENVISTAR® combined with platinum-based doublet chemotherapy compared to a placebo combined with the same chemotherapy regimen for the neoadjuvant/adjuvant treatment of patients with resectable Stage III NSCLC. Key study endpoints include event-free survival (EFS), major pathological response (MPR) rate, and complete pathological response (pCR) rate.