drugset / Trial / NCT06123754

Phase III Study of Envafolimab Versus Placebo Plus Chemotherapy in Resectable Stage III NSCLC

NCT06123754

Phase 3 Recruiting 390 enrolled 3D Medicines (Sichuan) Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a randomized, controlled, double-blind, multicenter Phase 3 clinical study to assess the efficacy and safety of envafolimab plus platinum-based doublet chemotherapy versus placebo plus platinum-based doublet chemotherapy as neoadjuvant/adjuvant therapy in subjects with resectable stage IIIA and IIIB (N2) NSCLC. Primary study endpoints are MPR rate assessed by BIPR and EFS assessed by BIRC.

Timeline

Start
2023-11-17
Primary completion
2027-12-30
Completion
2027-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Envafolimab Monoclonal antibody 600 mg Subcutaneous