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

Sponsor
BeiGene (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04379635
Collaborator
(none)
450
Enrollment
48
Locations
2
Arms
65.1
Anticipated Duration (Months)
9.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
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
Actual Study Start Date :
May 29, 2020
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
Nov 1, 2025

Arms and Interventions

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: Placebos
    Placebo to match tislelizumab IV infusion

    Drug: Carboplatin
    administered via IV infusion

    Outcome Measures

    Primary Outcome Measures

    1. Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set [Up to 3 months following completion of neoadjuvant treatment]

    2. Event-free survival (EFS) in ITT analysis set as Assessed by the Blinded Independent Central Review (BICR) [Up to 5 years]

    Secondary Outcome Measures

    1. Overall survival (OS) in the ITT set [Up to 5 years]

    2. Pathological complete response (pCR) rate [Up to 5 years]

    3. Objective Response Rate (ORR) [Up to 5 years]

    4. Disease-Free Survival (DFS) in ITT analysis set [Up to 5 years]

    5. Event-free survival (EFS) Assessed by the Investigator [Up to 5 years]

    6. Number of participants experiencing treatment-emergent adverse events (TEAEs) [Up to 5 years]

    7. Efficacy and Safety as Assessed by Health-related quality of life (HRQoL) Questionnaire [Up to 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Anhui Provincial Hospital Hefei Anhui China 230001
    2 The First Affiliated Hospital Of Anhui Medical University Hefei Anhui China 230022
    3 Beijing Cancer Hospital Beijing Beijing China 100142
    4 Beijing Hospital Beijing Beijing China 100730
    5 Peking Union Medical College Hospital - Oncology Beijing Beijing China 100730
    6 Beijing Friendship Hospital, Capital Medical University Beijing Beijing China
    7 Capital Medical University Xuanwu Hospital Beijing Beijing China
    8 Peking University Pepole's Hospital Beijing Beijing China
    9 Fujian Medical university union hospital Fuzhou Fujian China 350001
    10 Fujian Provincial Cancer Hospital Fuzhou Fujian China 350014
    11 Quanzhou First Hospital of Fujian Province Quanzhou Fujian China 362002
    12 First Affiliated Hospital of Xiamen University Xiamen Fujian China 361003
    13 Cancer Center of Guangzhou Medical University Guangzhou Guangdong China 510059
    14 Jiangmen Central Hospital Jiangmen Guangdong China
    15 Cancer Hospital of Shantou University Medical College - Oncology Shantou Guangdong China 515031
    16 Guangxi Medical University Affiliated Tumor Hospital& Oncology Medical College Nanning Guangxi China 530021
    17 Hainan Cancer Hospital Haikou Hainan China
    18 Harbin Medical University Cancer Hospital Harbin Heilongjiang China 150081
    19 Luoyang Central Hospital Luoyang Henan China
    20 The second affiliated hospital of Zhengzhou University Zhengzhou Henan China
    21 Hubei Cancer Hospital Wuhan Hubei China 430079
    22 Union Hospital of Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei China
    23 Hunan Cancer Hospital Changsha Hunan China
    24 Nanjing Drum Tower Hospital Nanjing Jiangsu China 21008
    25 The First Affiliated Hospital of Soochow University Suzhou Jiangsu China 215006
    26 The First affiliated hospital of Nanchang University Nanchang Jiangxi China
    27 Jilin Cancer Hospital Changchun Jilin China 132000
    28 Jilin Province People's Hospital Changchun Jilin China
    29 The First Affilliated Hospital of Jilin University Changchun Jilin China
    30 The Second Hospital of Dalian Medical University Dalian Liaoning China 116044
    31 Liaoning Cancer Hospital Shenyang Liaoning China 110042
    32 General Hospital of Ningxia Medical University Yinchuan Ningxia China
    33 Jinan Central Hospital Jinan Shandong China 250013
    34 Shanghai Pulmonary Hospital Shanghai Shanghai China 200433
    35 Fudan University Affiliated Zhongshan Hospital Shanghai Shanghai China
    36 Fudan University Shanghai Cancer Center Shanghai Shanghai China
    37 The First Hospital of Shanxi Medical University Taiyuan Shanxi China
    38 West China Hospital ,Sichuan University Chengdu Sichuan China 610041
    39 Sichuan Cancer Hospital Chengdu Sichuan China 610042
    40 General Hospital of Tianjin Medical University Tianjin Tianjin China 300070
    41 Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin China
    42 Yunnan Cancer Hospital Kunming Yunnan China
    43 The Second Affiliated Hospital of Zhejiang University School of Medicine Hangzhou Zhejiang China 310009
    44 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310022
    45 The First Affiliated Hospital of College of Medicine, Zhejiang University Hangzhou Zhejiang China
    46 Ningbo No.2 Hospital Ningbo Zhejiang China
    47 Sun Yat-sen University - Cancer Center (SYSUCC) Guangzhou China 510060
    48 Shanghai Chest Hospital Shanghai China

    Sponsors and Collaborators

    • BeiGene

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    BeiGene
    ClinicalTrials.gov Identifier:
    NCT04379635
    Other Study ID Numbers:
    • BGB-A317-315
    • CTR20200821
    First Posted:
    May 7, 2020
    Last Update Posted:
    Feb 7, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Paclitaxel
    Carboplatin
    Pemetrexed

    Study Results

    No Results Posted as of Feb 7, 2022