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

Non Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04379635
• Other study ID #: BGB-A317-315
• Secondary ID: CTR20200821
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 29, 2020
• Est. completion date: November 2025

Study information

• Verified date: May 2024
• Source: BeiGene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 453
• Est. completion date: November 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non Small Cell Lung Cancer

Intervention

Drug:
• Tislelizumab
administered via Intravenous (IV) injection
• Cisplatin injection
administered via IV infusion
• Paclitaxel injection
administered via IV infusion
• Pemetrexed Disodium
administered via IV infusion
• Placebos
Placebo to match tislelizumab IV infusion
• Carboplatin
administered via IV infusion

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Capital Medical University Xuanwu Hospital	Beijing	Beijing
China	Peking Union Medical College Hospital - Oncology	Beijing	Beijing
China	Peking University Pepole's Hospital	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	Jilin Province People's Hospital	Changchun	Jilin
China	The First Affilliated Hospital of Jilin University	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	West China Hospital ,Sichuan University	Chengdu	Sichuan
China	The Second Hospital of Dalian Medical University	Dalian	Liaoning
China	Fujian Medical university union hospital	Fuzhou	Fujian
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	Cancer Center of Guangzhou Medical University	Guangzhou	Guangdong
China	Sun Yat-sen University - Cancer Center (SYSUCC)	Guangzhou
China	Hainan Cancer Hospital	Haikou	Hainan
China	The First Affiliated Hospital of College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	The First Affiliated Hospital Of Anhui Medical University	Hefei	Anhui
China	Jiangmen Central Hospital	Jiangmen	Guangdong
China	Jinan Central Hospital	Jinan	Shandong
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	Luoyang Central Hospital	Luoyang	Henan
China	The First affiliated hospital of Nanchang University	Nanchang	Jiangxi
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hospital& Oncology Medical College	Nanning	Guangxi
China	Ningbo No.2 Hospital	Ningbo	Zhejiang
China	Quanzhou First Hospital of Fujian Province	Quanzhou	Fujian
China	Fudan University Affiliated Zhongshan Hospital	Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	Cancer Hospital of Shantou University Medical College - Oncology	Shantou	Guangdong
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	General Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Union Hospital of Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei
China	First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia
China	The second affiliated hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set		Up to 3 months following completion of neoadjuvant treatment
Primary	Event-free survival (EFS) in ITT analysis set as Assessed by the Blinded Independent Central Review (BICR)		Up to 5 years
Secondary	Overall survival (OS) in the ITT set		Up to 5 years
Secondary	Pathological complete response (pCR) rate		Up to 5 years
Secondary	Objective Response Rate (ORR)		Up to 5 years
Secondary	Disease-Free Survival (DFS) in ITT analysis set		Up to 5 years
Secondary	Event-free survival (EFS) Assessed by the Investigator		Up to 5 years
Secondary	Number of participants experiencing treatment-emergent adverse events (TEAEs)		Up to 5 years
Secondary	Efficacy and Safety as Assessed by Health-related quality of life (HRQoL) Questionnaire		Up to 5 years