Clinical Trial

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

Recruiting Phase 3
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Record status
This record was last updated November 4, 2021 (before its estimated April 15, 2023 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2020-03-19; most recent amendment 2021-10-27.
Status change: Not Yet Recruiting → Recruiting 2021-03-23
Trial Details
NCT Number NCT04316364
Lead Sponsor Jiangsu HengRui Medicine Co., Ltd.
Conditions Non-Small-Cell Lung Cancer
Enrollment 537 participants
Start Date 2020-07-14
Primary Completion 2023-04-15 (estimated)
Study Completion 2026-12-15 (estimated)
Updated on ClinicalTrials.gov 2021-11-04