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Clinical Trials in the USA / NCT05635708
Active, not recruiting Phase 2

A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer

NCT05635708 · tracked via the Priya Life Science USA tracker
Sponsor
BeiGene
Phase
Phase 2
Started
2023-03-07
Last updated
2026-04-15

Condition(s) studied

Non-small Cell Lung CancerMetastatic Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

TislelizumabBGB-A445LBL-007CarboplatinCisplatinpemetrexedPaclitaxelNab paclitaxelBGB-15025

Tislelizumab: Administered by intravenous infusion

BGB-A445: Administered by intravenous infusion

LBL-007: Administered by intravenous infusion

Carboplatin: Investigator's choice; administered by intravenous infusion

Cisplatin: Investigator's choice; administered by intravenous infusion

pemetrexed: Investigator's choice; administered by intravenous infusion

Paclitaxel: Investigator's choice; administered by intravenous infusion

Nab paclitaxel: Investigator's choice; administered by intravenous infusion

BGB-15025: Administered Orally

Study summary

The purpose of this study is to assess the antitumor activity, safety, and tolerability of tislelizumab plus investigational agent(s) with or without chemotherapy. This study is structured as a master protocol with separate sub- studies. Sub-study 1 includes participants with non-small cell lung cancer (NSCLC) with high programmed cell death protein ligand-1 (PD-L1) expression (≥ 50%), and Sub-study 2 includes participants with NSCLC with low or negative (PD-L1) expression (\< 50%).

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: 1. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), including nonsquamous or squamous subtypes, that is either locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC. 2. No prior systemic therapy administered as the primary treatment for metastatic NSCLC. Prior adjuvant or neoadjuvant chemotherapy, definitive chemoradiation, or adjuvant radiotherapy for locally advanced disease is permitted, provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months prior to randomization/enrollment. 3. Tumor programmed death-ligand 1 (PD-L1) expression must be evaluable, as determined by a local or central laboratory using archival tumor tissue or a fresh biopsy. Participants with unknown PD-L1 expression are not eligible. 4. At least one measurable lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Key Exclusion Criteria: 1. Diagnosis of mixed small cell lung cancer. 2. Known genomic alterations for which effective targeted therapies are available according to local standard of care, including but not limited to: * Epidermal growth factor receptor (EGFR) mutations * Anaplastic lymphoma kinase (ALK) rearrangements * B-Raf proto-oncogene (BRAF) mutations * Rearranged during transfection (RET) fusions * c-ros oncogene 1 (ROS1) rearrangements 3. Participants with nonsquamous NSCLC and unknown EGFR mutation status must undergo local testing. Those found to have EGFR-sensitizing mutations will be excluded. 4. Prior treatment with immune-based therapies that target immune checkpoint pathways, including: * PD-1 (programmed cell death protein 1) inhibitors * PD-L1 (programmed death-ligand 1) inhibitors * PD-L2 (programmed death-ligand 2) inhibitors * TIGIT (T cell immunoreceptor with Ig and ITIM domains) inhibitors * LAG-3 (lymphocyte activation gene 3) inhibitors 5. Participants previously treated with these agents in a neoadjuvant, adjuvant, or consolidation setting may be eligible if a treatment-free interval of at least 6 months has elapsed since the last dose and radiologic evidence of recurrence is present. 6. Use of Chinese herbal medicines or Chinese patent medicines intended for cancer control within 14 days prior to randomization/enrollment. 7. Presence of active leptomeningeal disease, untreated or uncontrolled brain metastases, or active autoimmune disease. Note: Additional protocol-defined and sub-study-specific criteria may apply.

Primary outcome measure(s)

Trial sites (61)

FacilityCityRegionStatus
Valkyrie Clinical Trials Los Angeles California
Massachusetts General Hospital Boston Massachusetts
Memorial Sloan Kettering Cancer Center Mskcc New York New York
Providence Portland Medical Center Portland Oregon
The University of Texas Md Anderson Cancer Center Houston Texas
Blacktown Cancer and Haematology Centre Blacktown New South Wales
Chris Obrien Lifehouse Camperdown New South Wales
Northern Beaches Hospital Frenchs Forest New South Wales
Port Macquarie Base Hospital Port Macquarie New South Wales
One Clinical Research Nedlands Western Australia
St John of God Health Care Subiaco Western Australia
Hospital de Amor Barretos Barretos Brazil
Hospital Do Cancer de Londrina Londrina Brazil
Centro Gaucho Integrado de Oncologia Hospital Mae de Deus Porto Alegre Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto São José do Rio Preto Brazil
Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira São Paulo Brazil
Cross Cancer Institute Edmonton Alberta
The Second Hospital of Anhui Medical University Hefei Anhui
The Fifth Medical Center of Chinese Pla General Hospital Beijing Beijing Municipality
Fujian Cancer Hospital Fuzhou Fujian
Affiliated Hospital of Hebei University Baoding Hebei
Harbin Medical University Cancer Hospital Harbin Heilongjiang
Henan Cancer Hospital Zhengzhou Henan
Hubei Cancer Hospital Wuhan Hubei
Nantong Tumor Hospital Branch North Nantong Jiangsu
The First Affiliated Hospital of Soochow University Suzhou Jiangsu
The First Affiliated Hospital of Nanchang University Branch Xianghu Nanchang Jiangxi
Jining No1 Peoples Hospital East Branch Jining Shandong
Linyi Peoples Hospital Linyi Shandong
Affiliated Zhongshan Hospital of Fudan University Shanghai Shanghai Municipality
Shanghai East Hospital Branch Hospital Shanghai Shanghai Municipality
Shanghai Pulmonary Hospital Shanghai Shanghai Municipality
Shanxi Provincial Cancer Hospital Taiyuan Shanxi
Tianjin Medical University Cancer Institute and Hospital Tianjin Tianjin Municipality
Taizhou Hospital of Zhejiang Taizhou Zhejiang
Institut Curie Paris France
Chu Nantes Hopital Nord Laennec SaintHerblain France
Arensia Exploratory Medicine Llc Tbilisi Georgia
Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs Roma Italy
Centro Ricerche Cliniche Di Verona Verona Italy

+ 21 more sites — see the full list on the official registry below.

More BeiGene trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05635708 on ClinicalTrials.gov ↗ ← All trials in the USA