NCT06091943 is a Phase 1 clinical trial of Tislelizumab IV in Non-small Cell Lung Cancer, sponsored by BeiGene.

Who is sponsoring NCT06091943?

NCT06091943 is sponsored by BeiGene.

What drugs are being tested in NCT06091943?

Interventions in NCT06091943: Tislelizumab IV, Tislelizumab SC, Histology-Based Chemotherapy Doublet.

What condition does NCT06091943 study?

NCT06091943 studies Non-small Cell Lung Cancer.

Is NCT06091943 still recruiting?

NCT06091943 is currently active, enrolled. Last updated 12 August 2025.

Last reviewed 2025-08-12 · How we verify

NCT06091943

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

Study to Evaluate the Bioavailability of Tislelizumab Via Subcutaneous Injection in First-Line Treatment of Participants With Advanced or Metastatic Non-Small Cell Lung Cancer

Active, enrolled Phase 1 Last updated 12 August 2025

What this trial tests

Phase 1 trial testing Tislelizumab IV in Non-small Cell Lung Cancer in 62 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

16 November 2023

Primary endpoint
31 July 2025

31 July 2026

Quick facts

Lead sponsor	BeiGene
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	16 November 2023
Primary completion	31 July 2025
Estimated completion	31 July 2026
Sites	15 locations across China, Georgia, Moldova

Drugs / interventions tested

Tislelizumab IV — full drug profile →
Tislelizumab SC — full drug profile →
Histology-Based Chemotherapy Doublet — 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

This is an open-label, multicenter, Phase 1 clinical study to evaluate the bioavailability of tislelizumab subcutaneous (SC) injection in the first-line treatment of participants with advanced or metastatic non-small cell lung cancer (NSCLC). This clinical study will be divided into 2 parts: dose/injection site exploration (Part 1) and dose expansion (Part 2).

Publications & conference data

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

Immune evasion in cancer: mechanisms and cutting-edge therapeutic approaches.
Tufail M, Jiang CH, Li N. · · 2025 · cited 82× · PMID 40739089 · DOI 10.1038/s41392-025-02280-1
Subcutaneously Administered Tislelizumab in Locally Advanced or Metastatic Non-Small Cell Lung Cancer: Pharmacokinetics and Safety Results from the BGB-A317-103 Phase I Study.
Chen M, Bulat I, Maglakelidze M, Li N, et al · · 2026 · PMID 41671081 · DOI 10.1158/1078-0432.ccr-25-2173

Verify or expand the search:

Other recruiting trials for Non-small Cell Lung Cancer

Currently open trials in the same condition.

NCT07431827 — MK-3475A±Calderasib (MK-1084) in Completely Resected Stage IIA-IIIB (N2) KRAS G12Cm NSCLC (MK-1084-013) · Phase 3 · recruiting
NCT05987956 — Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms · Phase 2, PHASE3 · active not recruiting
NCT07195695 — Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer Wit · Phase 3 · recruiting
NCT06686771 — Radiotherapy to Block Oligoprogression In Metastatic Non-Small-Cell Lung Cancer · Phase 3 · recruiting
NCT06477055 — The Recurrence Gene Profiles of Adjuvant Osimertinib Therapy in Resected Non-Small-Cell Lung Cancer · 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 NCT06091943 (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: 12 August 2025

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/NCT06091943.

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