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

Primary Purpose

Non Small Cell Lung Cancer

Status
Active
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tislelizumab
Cisplatin injection
Paclitaxel injection
Pemetrexed Disodium
Placebos
Carboplatin
Sponsored by
BeiGene
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anhui Provincial Hospital
  • The First Affiliated Hospital Of Anhui Medical University
  • Beijing Cancer Hospital
  • Beijing Hospital
  • Peking Union Medical College Hospital - Oncology
  • Beijing Friendship Hospital, Capital Medical University
  • Capital Medical University Xuanwu Hospital
  • Peking University Pepole's Hospital
  • Fujian Medical university union hospital
  • Fujian Provincial Cancer Hospital
  • Quanzhou First Hospital of Fujian Province
  • First Affiliated Hospital of Xiamen University
  • Cancer Center of Guangzhou Medical University
  • Jiangmen Central Hospital
  • Cancer Hospital of Shantou University Medical College - Oncology
  • Guangxi Medical University Affiliated Tumor Hospital& Oncology Medical College
  • Hainan Cancer Hospital
  • Harbin Medical University Cancer Hospital
  • Luoyang Central Hospital
  • The second affiliated hospital of Zhengzhou University
  • Hubei Cancer Hospital
  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
  • Hunan Cancer Hospital
  • Nanjing Drum Tower Hospital
  • The First Affiliated Hospital of Soochow University
  • The First affiliated hospital of Nanchang University
  • Jilin Cancer Hospital
  • Jilin Province People's Hospital
  • The First Affilliated Hospital of Jilin University
  • The Second Hospital of Dalian Medical University
  • Liaoning Cancer Hospital
  • General Hospital of Ningxia Medical University
  • Jinan Central Hospital
  • Shanghai Pulmonary Hospital
  • Fudan University Affiliated Zhongshan Hospital
  • Fudan University Shanghai Cancer Center
  • The First Hospital of Shanxi Medical University
  • West China Hospital ,Sichuan University
  • Sichuan Cancer Hospital
  • General Hospital of Tianjin Medical University
  • Tianjin Medical University Cancer Institute and Hospital
  • Yunnan Cancer Hospital
  • The Second Affiliated Hospital of Zhejiang University School of Medicine
  • Zhejiang Cancer Hospital
  • The First Affiliated Hospital of College of Medicine, Zhejiang University
  • Ningbo No.2 Hospital
  • Sun Yat-sen University - Cancer Center (SYSUCC)
  • Shanghai Chest Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab

Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo

Arm Description

Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium

Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium

Outcomes

Primary Outcome Measures

Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set
Event-free survival (EFS) in ITT analysis set as Assessed by the Blinded Independent Central Review (BICR)

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2020
Last Updated
March 1, 2023
Sponsor
BeiGene
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1. Study Identification

Unique Protocol Identification Number
NCT04379635
Brief Title
Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 29, 2020 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
November 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
453 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab
Arm Type
Experimental
Arm Description
Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Arm Title
Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Other Intervention Name(s)
BGB-A317
Intervention Description
administered via Intravenous (IV) injection
Intervention Type
Drug
Intervention Name(s)
Cisplatin injection
Intervention Description
administered via IV infusion
Intervention Type
Drug
Intervention Name(s)
Paclitaxel injection
Intervention Description
administered via IV infusion
Intervention Type
Drug
Intervention Name(s)
Pemetrexed Disodium
Intervention Description
administered via IV infusion
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Placebo to match tislelizumab IV infusion
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
administered via IV infusion
Primary Outcome Measure Information:
Title
Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set
Time Frame
Up to 3 months following completion of neoadjuvant treatment
Title
Event-free survival (EFS) in ITT analysis set as Assessed by the Blinded Independent Central Review (BICR)
Time Frame
Up to 5 years
Secondary Outcome Measure Information:
Title
Overall survival (OS) in the ITT set
Time Frame
Up to 5 years
Title
Pathological complete response (pCR) rate
Time Frame
Up to 5 years
Title
Objective Response Rate (ORR)
Time Frame
Up to 5 years
Title
Disease-Free Survival (DFS) in ITT analysis set
Time Frame
Up to 5 years
Title
Event-free survival (EFS) Assessed by the Investigator
Time Frame
Up to 5 years
Title
Number of participants experiencing treatment-emergent adverse events (TEAEs)
Time Frame
Up to 5 years
Title
Efficacy and Safety as Assessed by Health-related quality of life (HRQoL) Questionnaire
Time Frame
Up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 Key Exclusion Criteria: Any prior therapy for current lung cancer, including chemotherapy, or radiotherapy Known Epidermal growth factor receptor (EGFR) mutation or Anaplastic Lymphoma Kinase (ALK) gene translocation Any condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days before randomization 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Changli Wang, MD
Organizational Affiliation
Tianjin Medical University Cancer Institute and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anhui Provincial Hospital
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230001
Country
China
Facility Name
The First Affiliated Hospital Of Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230022
Country
China
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Facility Name
Beijing Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Peking Union Medical College Hospital - Oncology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Capital Medical University Xuanwu Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University Pepole's Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Fujian Medical university union hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Facility Name
Fujian Provincial Cancer Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350014
Country
China
Facility Name
Quanzhou First Hospital of Fujian Province
City
Quanzhou
State/Province
Fujian
ZIP/Postal Code
362002
Country
China
Facility Name
First Affiliated Hospital of Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361003
Country
China
Facility Name
Cancer Center of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510059
Country
China
Facility Name
Jiangmen Central Hospital
City
Jiangmen
State/Province
Guangdong
Country
China
Facility Name
Cancer Hospital of Shantou University Medical College - Oncology
City
Shantou
State/Province
Guangdong
ZIP/Postal Code
515031
Country
China
Facility Name
Guangxi Medical University Affiliated Tumor Hospital& Oncology Medical College
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Facility Name
Hainan Cancer Hospital
City
Haikou
State/Province
Hainan
Country
China
Facility Name
Harbin Medical University Cancer Hospital
City
Harbin
State/Province
Heilongjiang
ZIP/Postal Code
150081
Country
China
Facility Name
Luoyang Central Hospital
City
Luoyang
State/Province
Henan
Country
China
Facility Name
The second affiliated hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Hubei Cancer Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430079
Country
China
Facility Name
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Hunan Cancer Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
21008
Country
China
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
State/Province
Jiangsu
ZIP/Postal Code
215006
Country
China
Facility Name
The First affiliated hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
Jilin Cancer Hospital
City
Changchun
State/Province
Jilin
ZIP/Postal Code
132000
Country
China
Facility Name
Jilin Province People's Hospital
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The First Affilliated Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The Second Hospital of Dalian Medical University
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116044
Country
China
Facility Name
Liaoning Cancer Hospital
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
Country
China
Facility Name
Jinan Central Hospital
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250013
Country
China
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Fudan University Affiliated Zhongshan Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
Country
China
Facility Name
West China Hospital ,Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Sichuan Cancer Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610042
Country
China
Facility Name
General Hospital of Tianjin Medical University
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300070
Country
China
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
Country
China
Facility Name
The Second Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310022
Country
China
Facility Name
The First Affiliated Hospital of College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Ningbo No.2 Hospital
City
Ningbo
State/Province
Zhejiang
Country
China
Facility Name
Sun Yat-sen University - Cancer Center (SYSUCC)
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
Shanghai Chest Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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