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

NCT ID: NCT05635708

Last Updated: 2026-02-05

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

PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-07

Study Completion Date

2026-10-31

Brief Summary

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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%).

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sub-study 1: Arm 1A

Tislelizumab + BGB-A445

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered by intravenous infusion

BGB-A445

Intervention Type DRUG

Administered by intravenous infusion

Sub-study 1: Arm 2A

Tislelizumab + LBL-007

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered by intravenous infusion

LBL-007

Intervention Type DRUG

Administered by intravenous infusion

Sub-study 1: Arm 3A

Tislelizumab + BGB-15025

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered by intravenous infusion

BGB-15025

Intervention Type DRUG

Administered Orally

Sub-study 1: Reference Arm Tislelizumab alone

Tislelizumab alone

Group Type ACTIVE_COMPARATOR

Tislelizumab

Intervention Type DRUG

Administered by intravenous infusion

Sub-study 2: Arm 1B

Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered by intravenous infusion

BGB-A445

Intervention Type DRUG

Administered by intravenous infusion

Carboplatin

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Cisplatin

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

pemetrexed

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Paclitaxel

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Nab paclitaxel

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Sub-study 2: Arm 2B

Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered by intravenous infusion

LBL-007

Intervention Type DRUG

Administered by intravenous infusion

Carboplatin

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Cisplatin

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

pemetrexed

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Paclitaxel

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Nab paclitaxel

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Sub-study 2: Arm 3B

Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025

Group Type EXPERIMENTAL

Tislelizumab

Intervention Type DRUG

Administered by intravenous infusion

Carboplatin

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Cisplatin

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

pemetrexed

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Paclitaxel

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Nab paclitaxel

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

BGB-15025

Intervention Type DRUG

Administered Orally

Sub-study 2: Reference Arm

Tislelizumab + investigator's choice of histology-appropriate chemotherapy

Group Type ACTIVE_COMPARATOR

Tislelizumab

Intervention Type DRUG

Administered by intravenous infusion

Carboplatin

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Cisplatin

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

pemetrexed

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Paclitaxel

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Nab paclitaxel

Intervention Type DRUG

Investigator's choice; administered by intravenous infusion

Interventions

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Tislelizumab

Administered by intravenous infusion

Intervention Type DRUG

BGB-A445

Administered by intravenous infusion

Intervention Type DRUG

LBL-007

Administered by intravenous infusion

Intervention Type DRUG

Carboplatin

Investigator's choice; administered by intravenous infusion

Intervention Type DRUG

Cisplatin

Investigator's choice; administered by intravenous infusion

Intervention Type DRUG

pemetrexed

Investigator's choice; administered by intravenous infusion

Intervention Type DRUG

Paclitaxel

Investigator's choice; administered by intravenous infusion

Intervention Type DRUG

Nab paclitaxel

Investigator's choice; administered by intravenous infusion

Intervention Type DRUG

BGB-15025

Administered Orally

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BeiGene

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

BeiGene

Locations

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Valkyrie Clinical Trials

Los Angeles, California, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Site Status

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Site Status

Chris Obrien Lifehouse

Camperdown, New South Wales, Australia

Site Status

Northern Beaches Hospital

Frenchs Forest, New South Wales, Australia

Site Status

Port Macquarie Base Hospital

Port Macquarie, New South Wales, Australia

Site Status

One Clinical Research

Nedlands, Western Australia, Australia

Site Status

St John of God Health Care

Subiaco, Western Australia, Australia

Site Status

Hospital de Amor Barretos

Barretos, , Brazil

Site Status

Hospital Do Cancer de Londrina

Londrina, , Brazil

Site Status

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, , Brazil

Site Status

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, , Brazil

Site Status

Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira

São Paulo, , Brazil

Site Status

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Site Status

The Fifth Medical Center of Chinese Pla General Hospital

Beijing, Beijing Municipality, China

Site Status

Fujian Cancer Hospital

Fuzhou, Fujian, China

Site Status

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Site Status

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

Hubei Cancer Hospital

Wuhan, Hubei, China

Site Status

Nantong Tumor Hospital Branch North

Nantong, Jiangsu, China

Site Status

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Site Status

The First Affiliated Hospital of Nanchang University Branch Xianghu

Nanchang, Jiangxi, China

Site Status

Jining No Peoples Hospital East Branch

Jining, Shandong, China

Site Status

Linyi Peoples Hospital

Linyi, Shandong, China

Site Status

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Shanghai East Hospital Branch Hospital

Shanghai, Shanghai Municipality, China

Site Status

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Site Status

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Site Status

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Site Status

Taizhou Hospital of Zhejiang

Taizhou, Zhejiang, China

Site Status

Institut Curie

Paris, , France

Site Status

Chu Nantes Hopital Nord Laennec

SaintHerblain, , France

Site Status

Arensia Exploratory Medicine Llc

Tbilisi, , Georgia

Site Status

Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs

Roma, , Italy

Site Status

Centro Ricerche Cliniche Di Verona

Verona, , Italy

Site Status

Pulau Pinang Hospital

George Town, , Malaysia

Site Status

Tengku Ampuan Afzan Hospital

Kuantan, , Malaysia

Site Status

Sarawak General Hospital

Kuching, , Malaysia

Site Status

The Institute of Oncology, Arensia Exploratory Medicine

Chisinau, , Moldova

Site Status

Institute of Oncology Bucharest Prof Dr Alexandru Trestioreanu

Bucureti, , Romania

Site Status

Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricu

ClujNapoca, , Romania

Site Status

National Cancer Centre Singapore

Singapore, , Singapore

Site Status

Chungbuk National University Hospital

Cheongju-si, Chungcheongbukdo, South Korea

Site Status

Seoul National University Bundang Hospital

BundangGu SeongnamSi, Gyeonggi-do, South Korea

Site Status

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do, South Korea

Site Status

The Catholic University of Korea, St Vincents Hospital

PaldalGu SuwonSi, Gyeonggi-do, South Korea

Site Status

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

Site Status

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Site Status

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

Site Status

Hospital Universitario Vall Dhebron

Barcelona, , Spain

Site Status

Hospital Universitario de Octubre

Madrid, , Spain

Site Status

Hospital Universitario Virgen Del Rocio

Seville, , Spain

Site Status

Songklanagarind Hospital (Prince of Songkhla University)

Hat Yai, , Thailand

Site Status

Srinagarind Hospital (Khon Kaen University)

Muang, , Thailand

Site Status

Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)

Muang, , Thailand

Site Status

Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)

Ongkharak, , Thailand

Site Status

Countries

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United States Australia Brazil Canada China France Georgia Italy Malaysia Moldova Romania Singapore South Korea Spain Thailand

Other Identifiers

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CTR20230892

Identifier Type: OTHER

Identifier Source: secondary_id

2022-502738-18-00

Identifier Type: CTIS

Identifier Source: secondary_id

BGB-LC-201

Identifier Type: -

Identifier Source: org_study_id

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