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Comparing the Efficacy and Sa...

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

Last Updated: 2025-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

453 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-29

Study Completion Date

2027-03-31

Brief Summary

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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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Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Tislelizumab

Tislelizumab + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

administered via Intravenous (IV) injection

Cisplatin injection

Intervention Type DRUG

administered via IV infusion

Paclitaxel injection

Intervention Type DRUG

administered via IV infusion

Pemetrexed Disodium

Intervention Type DRUG

administered via IV infusion

Carboplatin

Intervention Type DRUG

administered via IV infusion

Neoadjuvant chemotherapy + Neoadjuvant/Adjuvant Placebo

Placebo + cisplatin/carboplatin + paclitaxel or Pemetrexed Disodium

Group Type PLACEBO_COMPARATOR

Cisplatin injection

Intervention Type DRUG

administered via IV infusion

Paclitaxel injection

Intervention Type DRUG

administered via IV infusion

Pemetrexed Disodium

Intervention Type DRUG

administered via IV infusion

Placebos

Intervention Type DRUG

Placebo to match tislelizumab IV infusion

Carboplatin

Intervention Type DRUG

administered via IV infusion

Interventions

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Tislelizumab

administered via Intravenous (IV) injection

Intervention Type DRUG

Cisplatin injection

administered via IV infusion

Intervention Type DRUG

Paclitaxel injection

administered via IV infusion

Intervention Type DRUG

Pemetrexed Disodium

administered via IV infusion

Intervention Type DRUG

Placebos

Placebo to match tislelizumab IV infusion

Intervention Type DRUG

Carboplatin

administered via IV infusion

Intervention Type DRUG

Other Intervention Names

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BGB-A317

Eligibility Criteria

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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

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Changli Wang, MD

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University Cancer Institute and Hospital

Locations

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