Fact CheckerSign in

NCT04379635Active, not recruitingPhase 3

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

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

Source: ClinicalTrials.gov · Last updated 18 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
453 (actual)
First submitted
4 May 2020
Start date
29 May 2020
Primary completion date
21 Aug 2023
Lead sponsor
BeiGene
Diseases
Lung cancer
NCT number
NCT04379635

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 453
  • From 29 May 2020 to the primary completion date, 21 Aug 2023
  • 44 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Any prior therapy for current lung cancer, including chemotherapy, or radiotherapy
  • Any condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before randomization

Other illness

  • Active autoimmune diseases or history of autoimmune diseases that may relapse
  • History of interstitial lung disease, non-infectious pneumonitis or uncontrolled diseases including pulmonary fibrosis, acute lung diseases, etc.
    • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Lab values

  • Known Epidermal growth factor receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) gene translocation

Who the study is looking for

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically confirmed Stage II or IIIA NSCLC
  • Measurable disease as assessed per RECIST v1.1
  • Confirm eligibility for an R0 resection with curative intent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (44)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Beijing Friendship Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Peking Union Medical College Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Beijing Cancer Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Xuanwu Hospital, Capital Medical University
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Peking University Peoples Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Jilin Cancer Hospital
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
The First Hospital of Jilin University
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
Hunan Cancer Hospital
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status
West China Hospital,Sichuan University
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Sichuan Cancer Hospital and Institute
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Fujian Cancer Hospital
Coordinator of this site? Confirm its status
FuzhouChinaUnknown status
Fujian Medical University Union Hospital
Coordinator of this site? Confirm its status
FuzhouChinaUnknown status
Sun Yat-sen University Cancer Center
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Cancer Center of Guangzhou Medical University
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Hainan Cancer Hospital
Coordinator of this site? Confirm its status
HaikouChinaUnknown status
Zhejiang Cancer Hospital
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
The Second Affiliated Hospital of Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
Coordinator of this site? Confirm its status
HarbinChinaUnknown status
Anhui Provincial Hospital
Coordinator of this site? Confirm its status
HefeiChinaUnknown status
Jiangmen Central Hospital
Coordinator of this site? Confirm its status
JiangmenChinaUnknown status
Yunnan Cancer Hospital
Coordinator of this site? Confirm its status
KunmingChinaUnknown status
Luoyang Central Hospital
Coordinator of this site? Confirm its status
LuoyangChinaUnknown status
The First Affiliated Hospital of Nanchang University Branch Donghu
Coordinator of this site? Confirm its status
NanchangChinaUnknown status
The First Affiliated Hospital of Nanchang University Branch Xianghu
Coordinator of this site? Confirm its status
NanchangChinaUnknown status
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Coordinator of this site? Confirm its status
NanjingChinaUnknown status
The Tumor Hospital Affiliated to Guangxi Medical University
Coordinator of this site? Confirm its status
NanningChinaUnknown status
Hwa Mei Hospital, University of Chinese Academy of Sciences (Ningbo No2 Hospital)
Coordinator of this site? Confirm its status
NingboChinaUnknown status
Quanzhou First Affliated Hospital of Fujian Medical University
Coordinator of this site? Confirm its status
QuanzhouChinaUnknown status
Shanghai Pulmonary Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Shanghai Chest Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Fudan University Shanghai Cancer Center
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Affiliated Zhongshan Hospital of Fudan University
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Cancer Hospital of Shantou University Medical College
Coordinator of this site? Confirm its status
ShantouChinaUnknown status
Liaoning Cancer Hospital and Institute
Coordinator of this site? Confirm its status
ShenyangChinaUnknown status
First Hospital of Shanxi Medical University
Coordinator of this site? Confirm its status
TaiyuanChinaUnknown status
Tianjin Medical University Cancer Institute and Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
Tianjin Medical University General Hospital
Coordinator of this site? Confirm its status
TianjinChinaUnknown status
Union Hospital of Tongji Medical College Huazhong University of Science and Technology
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
Hubei Cancer Hospital
Coordinator of this site? Confirm its status
WuhanChinaUnknown status
The First Affiliated hospital of Xiamen University
Coordinator of this site? Confirm its status
XiamenChinaUnknown status
The First Affiliated Hospital of Xian Jiaotong University
Coordinator of this site? Confirm its status
Xi'anChinaUnknown status
General Hospital of Ningxia Medical University
Coordinator of this site? Confirm its status
YinchuanChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.