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

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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

ClinicalTrials.gov ID

NCT04379635

Acronym / sponsor ID

BGB-A317-315

Conditions

Non Small Cell Lung Cancer

Phase

Phase 3

Study type

Interventional

Recruitment status

Active, not recruiting

Enrolment

453 participants (actual)

Lead sponsor

BeiGeneIndustry (pharma, biotech, devices)

Study start

29 May 2020 (actual)

Primary completion

21 Aug 2023 (actual)

Study completion

31 Mar 2027 (estimated)

First posted

7 May 2020 (actual)

Results

Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Randomised

Intervention model

Parallel groups

Masking

Triple blind (participant, care provider, investigator)

Number of arms

2

Who may qualify

Ages

18 years and older

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
• Derived from this study: PubMed 41344593Wang C, Wang W, Liu H, Chen Q, Chen C, Liu L, Zhang P, Zhao G, Yang F, Han G, Yu B, Yang Y, Chen H, Jiang J, Tan L, Xu S, Mao N, Hu J, Zhang L, Zhang Z, Yao B, Wang S, Leaw S, Naicker K, Zheng W, Yu C, Yue D; RATIONALE-315 investigators. Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer: final analysis of the randomized RATIONALE-315 trial. Ann Oncol. 2026 Apr;37(4):544-554. doi: 10.1016/j.annonc.2025.11.017. Epub 2025 Dec 2.
• Derived from this study: PubMed 39581197Yue D, Wang W, Liu H, Chen Q, Chen C, Liu L, Zhang P, Zhao G, Yang F, Han G, Cheng Y, Yu B, Yang Y, Chen H, Jiang J, Tan L, Xu S, Mao N, Hu J, Zhang L, Yao B, Wang S, Wang RH, Zheng W, Wang C; RATIONALE-315 investigators. Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomised clinical trial. Lancet Respir Med. 2025 Feb;13(2):119-129. doi: 10.1016/S2213-2600(24)00269-8. Epub 2024 Nov 21.
• Individual participant dataSharing planned: Yes. BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

44 sites in 1 country: see every site and its status.