drugset / Trial / NCT04316364

A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC

NCT04316364

Phase 3 Recruiting 537 enrolled Jiangsu HengRui Medicine Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This trial is designed to evaluate the efficacy, safety and immunogenicity of neoadjuvant treatment with monoclonal antibody SHR-1316 or placebo in combination with platinum doublet chemotherapy in participants with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer (NSCLC) followed by adjuvant SHR-1316 or placebo and monitoring.

Timeline

Start
2020-07-14
Primary completion
2023-04-15
Completion
2026-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Adebrelimab Monoclonal antibody Intravenous
Background Carboplatin Small molecule Intravenous
Background Paclitaxel Small molecule Intravenous