NCT04379635 is a Phase 3 clinical trial of Tislelizumab in Non Small Cell Lung Cancer, sponsored by BeiGene.

Who is sponsoring NCT04379635?

NCT04379635 is sponsored by BeiGene.

What drugs are being tested in NCT04379635?

Interventions in NCT04379635: Tislelizumab, Cisplatin injection, Paclitaxel injection, Pemetrexed Disodium, Placebos, Carboplatin.

What condition does NCT04379635 study?

NCT04379635 studies Non Small Cell Lung Cancer.

Is NCT04379635 still recruiting?

NCT04379635 is currently active, enrolled. Last updated 18 March 2026.

Last reviewed 2026-03-18 · How we verify

NCT04379635

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled Phase 3 Last updated 18 March 2026

What this trial tests

Phase 3 trial testing Tislelizumab in Non Small Cell Lung Cancer in 453 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

29 May 2020

Primary endpoint
21 August 2023

31 March 2027

Quick facts

Lead sponsor	BeiGene
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	453
Start date	29 May 2020
Primary completion	21 August 2023
Estimated completion	31 March 2027
Sites	44 locations across China

Drugs / interventions tested

Tislelizumab (TISLELIZUMAB) — full drug profile →
Cisplatin injection — full drug profile →
Paclitaxel injection
Pemetrexed Disodium — full drug profile →
Placebos — full drug profile →
Carboplatin (Carboplatin) — full drug profile →

Conditions studied

Non Small Cell Lung Cancer — all drugs for Non Small Cell Lung Cancer →

Sponsor

BeiGene — full company profile →

Who can join

18 and older, any sex, with Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Neoadjuvant Chemoimmunotherapy for NSCLC: A Systematic Review and Meta-Analysis.
Sorin M, Prosty C, Ghaleb L, Nie K, et al · · 2024 · cited 150× · PMID 38512301 · DOI 10.1001/jamaoncol.2024.0057
Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer (RATIONALE-315): an interim analysis of a randomised clinical trial.
Yue D, Wang W, Liu H, Chen Q, et al · · 2025 · cited 74× · PMID 39581197 · DOI 10.1016/s2213-2600(24)00269-8
Emerging evidence and treatment paradigm of non-small cell lung cancer.
Liu SM, Zheng MM, Pan Y, Liu SY, et al · · 2023 · cited 70× · PMID 37069698 · DOI 10.1186/s13045-023-01436-2
Advances in molecular pathology and therapy of non-small cell lung cancer.
Huang Q, Li Y, Huang Y, Wu J, et al · · 2025 · cited 43× · PMID 40517166 · DOI 10.1038/s41392-025-02243-6
Developments in targeted therapy & immunotherapy-how non-small cell lung cancer management will change in the next decade: a narrative review.
Li MSC, Mok KKS, Mok TSK. · · 2023 · cited 37× · PMID 37675321 · DOI 10.21037/atm-22-4444
Emerging precision neoadjuvant systemic therapy for patients with resectable non-small cell lung cancer: current status and perspectives.
Godoy LA, Chen J, Ma W, Lally J, et al · · 2023 · cited 34× · PMID 36650586 · DOI 10.1186/s40364-022-00444-7
New systemic treatment paradigms in resectable non-small cell lung cancer and variations in patient access across Europe.
Houda I, Dickhoff C, Uyl-de Groot CA, Reguart N, et al · · 2024 · cited 22× · PMID 38476748 · DOI 10.1016/j.lanepe.2024.100840
Neoadjuvant immunotherapy in resectable non-small-cell lung cancer.
Chen LN, Wei AZ, Shu CA. · · 2023 · cited 17× · PMID 37007633 · DOI 10.1177/17588359231163798

Verify or expand the search:

Other trials of Tislelizumab

Trials testing the same drug.

NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer · Phase 2 · not yet recruiting
NCT07475026 — A Study of Neoadjuvant Tislelizumab Plus Lenvatinib in Resectable HCC at High Risk of Recurrence · Phase 3 · not yet recruiting
NCT07528274 — Microwave Ablation Plus Tislelizumab and Docetaxel in Advanced NSCLC After First-Line Immunotherapy Failure · Phase 2 · recruiting
NCT07290985 — AACR Adaptive Biomarker-Driven Organ Preservation Trial in Gastroesophageal Adenocarcinomas · Phase 2 · not yet recruiting
NCT07518706 — Neoadjuvant Tislelizumab-Lenvatinib vs Surgery Alone in Stage Ia HCC With Narrow Margin · Phase 2 · not yet recruiting

Other recruiting trials for Non Small Cell Lung Cancer

Currently open trials in the same condition.

NCT06951646 — ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immuno · Phase 2 · recruiting
NCT07503808 — A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types · Phase 1 · recruiting
NCT07269782 — A Phase II Study to Evaluate the Efficacy and Safety of HLX43 + Serplulimab as Neoadjuvant Therapy in Subjects With NSCL · Phase 2 · recruiting
NCT07306624 — Nelmastobart in Combination With Docetaxel in Non Small Cell Lung Cancer · Phase 2 · recruiting
NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting

Other BeiGene trials

Trials by the same sponsor.

NCT07169331 — A Study to Evaluate the Efficacy and Safety of Zanubrutinib in Chinese Adults With Treatment-Naive Waldenström Macroglob · Phase 4 · recruiting
NCT07100938 — A Study Investigating the Efficacy and Safety of BGB-45035 Versus Placebo in Adults With Moderate to Severe Active Rheum · Phase 2 · active not recruiting
NCT07005713 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Doses of BGB- · Phase 1 · active not recruiting
NCT06906809 — Effect of Phenytoin or Itraconazole on How BGB-16673 is Absorbed and Removed From the Body in Healthy Participants · Phase 1 · completed
NCT06803680 — A Study of BGB-B455 in Adults With Advanced or Metastatic Solid Tumors · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04379635 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by BeiGene
Last refreshed: 18 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04379635.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing