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NCT Number: NCT04379635

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anhui Provincial Hospital, Hefei, Anhui, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tislelizumab

Drug

administered via Intravenous (IV) injection

Other names: BGB-A317

Cisplatin injection

Drug

administered via IV infusion

Paclitaxel Injection

Drug

administered via IV infusion

pemetrexed disodium

Drug

administered via IV infusion

Placebos

Drug

Placebo to match tislelizumab IV infusion

carboplatin

Drug

administered via IV infusion

Primary outcomes

  1. Major pathological response (MPR) in Intent-to-Treat (ITT) analysis set

    Time frame: 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)

    Time frame: Up to 5 years

Secondary outcomes

  1. Overall survival (OS) in the ITT set

    Time frame: Up to 5 years

  2. Pathological complete response (pCR) rate

    Time frame: Up to 5 years

  3. Objective Response Rate (ORR)

    Time frame: Up to 5 years

  4. Disease-Free Survival (DFS) in ITT analysis set

    Time frame: Up to 5 years

  5. Event-free survival (EFS) Assessed by the Investigator

    Time frame: Up to 5 years

  6. Number of participants experiencing treatment-emergent adverse events (TEAEs)

    Time frame: Up to 5 years

  7. Efficacy and Safety as Assessed by Health-related quality of life (HRQoL) Questionnaire

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

BeiGene

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2023
Study completion
2027
First posted
May 7, 2020
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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