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

Recruiting Phase 3 Interventional Study
Non-Small-Cell Lung Cancer
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 70
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
537 (estimated)
Sponsor
Jiangsu HengRui Medicine Co., Ltd. · Industry
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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Have previously untreated, pathologically confirmed resectable Stage II, IIIA, or Selected IIIB NSCLC. Staging should be based on the 8th edition of the AJCC/UICC staging system * Evaluation by an attending …
Contacts

Vivian Shi, MD

+86 010-67166319

wei.shi@hengrui.com

CONTACT