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ACTIVE NOT RECRUITING
NCT04379635
PHASE3

Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)

Sponsor: BeiGene

View on ClinicalTrials.gov

Summary

The primary objective of this study is to evaluate and compare major pathological response(MPR) rate and event-free survival (EFS) in participants receiving tislelizumab plus platinum-based doublet chemotherapy as the new additional treatment followed by tislelizumab as adjuvant treatment versus participants receiving placebo plus platinum-based doublet chemotherapy as neoadjuvant treatment followed by placebo as adjuvant treatment.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Compare the Efficacy and Safety of Neoadjuvant Treatment With Tislelizumab (BGB-A317, Anti-PD-1 Antibody) or Placebo Plus Platinum-Based Doublet Chemotherapy Followed By Adjuvant Tislelizumab or Placebo in Resectable Stage II or IIIA Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

453

Start Date

2020-05-29

Completion Date

2027-03-31

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

Tislelizumab

administered via Intravenous (IV) injection

DRUG

Cisplatin injection

administered via IV infusion

DRUG

Paclitaxel injection

administered via IV infusion

DRUG

Pemetrexed Disodium

administered via IV infusion

DRUG

Placebos

Placebo to match tislelizumab IV infusion

DRUG

Carboplatin

administered via IV infusion

Locations (44)

Anhui Provincial Hospital

Hefei, Anhui, China

Peking University Peoples Hospital

Beijing, Beijing Municipality, China

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Beijing Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Quanzhou First Affliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, China

Sun Yat Sen University Cancer Center

Guangzhou, Guangdong, China

Jiangmen Central Hospital

Jiangmen, Guangdong, China

Cancer Hospital of Shantou University Medical College

Shantou, Guangdong, China

The Tumor Hospital Affiliated to Guangxi Medical University

Nanning, Guangxi, China

Hainan Cancer Hospital

Haikou, Hainan, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Luoyang Central Hospital

Luoyang, Henan, China

Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Drum Tower Hospital,the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanchang University Branch Donghu

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University Branch Xianghu

Nanchang, Jiangxi, China

Jilin Cancer Hospital

Changchun, Jilin, China

The First Hospital of Jilin University

Changchun, Jilin, China

Liaoning Cancer Hospital and Institute

Shenyang, Liaoning, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Sichuan Cancer Hospital and Institute

Chengdu, Sichuan, China

West China Hospital, Sichuan University

Chengdu, Sichuan, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No2 Hospital)

Ningbo, Zhejiang, China