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RECRUITING
NCT04316364
PHASE3

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

Sponsor: Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Randomized, Double-Blind, Multicenter, Phase Ib/III Clinical Study on PD-L1 Monoclonal Antibody SHR-1316 or Placebo in Combination With Chemotherapy as Perioperative Treatment of Resectable Stage II or III Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

537

Start Date

2020-07-14

Completion Date

2026-12-15

Last Updated

2021-11-04

Healthy Volunteers

No

Interventions

DRUG

SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin

Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Paclitaxel (Albumin Bound) will be administered intravenously on Day 1,8,15 of each 21-day cycle Drug: Carboplatin will be administered intravenously on Day 1 of each 21-day cycle

DRUG

SHR-1316、Chemotherapeutic

Drug: SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert

DRUG

Placebo、Chemotherapeutic

Drug: Placebo, will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle Drug: Chemotherapeutic drugs will be administered on Day 1 of each 21day cycle, if applicable, they will also be administered on Day 8 and/or Day 15 according to the drug package insert

Locations (7)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Henan Cancer Hospital

Zhengzhou, Henan, China

JiangSu Cancer Hospital

Nanjing, Jiangsu, China

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

West China Hospital,Sichuan University

Chengdu, Sichuan, China

ZheJiang Cancer Hospital

Hangzhou, Zhejiang, China