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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Non Small Cell Lung Cancer
• Intervention / Treatment: Drug: Tislelizumab; Drug: Cisplatin injection; Drug: Paclitaxel injection; Drug: Pemetrexed Disodium; Drug: Carboplatin; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 453
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangzhou, China, 510060
    • Sun Yat-sen University - Cancer Center (SYSUCC)
  • Shanghai, China
    • Shanghai Chest Hospital
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
    • Hefei, Anhui, China, 230022
      • The First Affiliated Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China, 100142
      • Beijing Cancer Hospital
    • Beijing, Beijing, China, 100730
      • Beijing Hospital
    • Beijing, Beijing, China
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital - Oncology
    • Beijing, Beijing, China
      • Capital Medical University Xuanwu Hospital
    • Beijing, Beijing, China
      • Peking University Pepole's Hospital
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Fujian Medical University Union Hospital
    • Fuzhou, Fujian, China, 350014
      • Fujian Provincial Cancer hospital
    • Quanzhou, Fujian, China, 362002
      • Quanzhou First Hospital of Fujian Province
    • Xiamen, Fujian, China, 361003
      • First Affiliated Hospital of Xiamen University
  • Guangdong
    • Guangzhou, Guangdong, China, 510059
      • Cancer Center of Guangzhou Medical University
    • Jiangmen, Guangdong, China
      • Jiangmen Central Hospital
    • Shantou, Guangdong, China, 515031
      • Cancer Hospital of Shantou University Medical College - Oncology
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Guangxi Medical University Affiliated Tumor Hospital& Oncology Medical College
  • Hainan
    • Haikou, Hainan, China
      • Hainan Cancer Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Harbin Medical University Cancer Hospital
  • Henan
    • Luoyang, Henan, China
      • Luoyang Central Hospital
    • Zhengzhou, Henan, China
      • The Second Affiliated Hospital of Zhengzhou University
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China
      • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Hunan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 21008
      • Nanjing Drum Tower Hospital
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
  • Jiangxi
    • Nanchang, Jiangxi, China
      • The First Affiliated Hospital of Nanchang University
  • Jilin
    • Changchun, Jilin, China
      • Jilin Province People's Hospital
    • Changchun, Jilin, China, 132000
      • Jilin Cancer Hospital
    • Changchun, Jilin, China
      • The First Affilliated Hospital of Jilin University
  • Liaoning
    • Dalian, Liaoning, China, 116044
      • The Second Hospital of Dalian Medical University
    • Shenyang, Liaoning, China, 110042
      • Liaoning Cancer Hospital
  • Ningxia
    • Yinchuan, Ningxia, China
      • General Hospital of Ningxia Medical University
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Fudan University Shanghai Cancer Center
    • Shanghai, Shanghai, China, 200433
      • Shanghai Pulmonary Hospital
    • Shanghai, Shanghai, China
      • Fudan University Affiliated Zhongshan Hospital
  • Shanxi
    • Taiyuan, Shanxi, China
      • The First Hospital of Shanxi Medical University
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital ,Sichuan University
    • Chengdu, Sichuan, China, 610042
      • Sichuan Cancer Hospital
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University Cancer Institute and Hospital
    • Tianjin, Tianjin, China, 300070
      • General Hospital of Tianjin Medical University
  • Yunnan
    • Kunming, Yunnan, China
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310022
      • Zhejiang Cancer Hospital
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital of College of Medicine, Zhejiang University
    • Ningbo, Zhejiang, China
      • Ningbo No.2 Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

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

Key Exclusion Criteria:

1. Any prior therapy for current lung cancer, including chemotherapy, or radiotherapy
2. Known Epidermal growth factor receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) gene translocation
3. Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before randomization
4. Active autoimmune diseases or history of autoimmune diseases that may relapse
5. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab; Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium	Drug: Tislelizumab; administered via Intravenous (IV) injection; Other Names: BGB-A317; Drug: Cisplatin injection; administered via IV infusion; Drug: Paclitaxel injection; administered via IV infusion; Drug: Pemetrexed Disodium; administered via IV infusion; Drug: Carboplatin; administered via IV infusion
Placebo Comparator: Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo; Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium	Drug: Cisplatin injection; administered via IV infusion; Drug: Paclitaxel injection; administered via IV infusion; Drug: Pemetrexed Disodium; administered via IV infusion; Drug: Carboplatin; administered via IV infusion; Drug: Placebos; Placebo to match tislelizumab IV infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set	Up to 3 months following completion of neoadjuvant treatment
Event-free survival (EFS) in ITT analysis set as Assessed by the Blinded Independent Central Review (BICR)	Up to 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival (OS) in the ITT set	Up to 5 years
Pathological complete response (pCR) rate	Up to 5 years
Objective Response Rate (ORR)	Up to 5 years
Disease-Free Survival (DFS) in ITT analysis set	Up to 5 years
Event-free survival (EFS) Assessed by the Investigator	Up to 5 years
Number of participants experiencing treatment-emergent adverse events (TEAEs)	Up to 5 years
Efficacy and Safety as Assessed by Health-related quality of life (HRQoL) Questionnaire	Up to 5 years

Collaborators and Investigators

• Sponsor: BeiGene
• Investigators: Principal Investigator: Changli Wang, MD, Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2020
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 5, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Antineoplastic Agents, Immunological; Folic Acid Antagonists; Carboplatin; Paclitaxel; Pemetrexed; Tislelizumab
• Other Study ID Numbers: BGB-A317-315; CTR20200821 (Registry Identifier: ChiCTR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No