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ACTIVE NOT RECRUITING

NCT05635708

PHASE2

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

Sponsor: BeiGene

View on ClinicalTrials.gov

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%).

Official title: Master Protocol: A Phase 2, Open-label, Multi-arm Study of Tislelizumab in Combination With Investigational Agents With or Without Chemotherapy in Patients With Previously Untreated, Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2023-03-07

Completion Date

2026-10

Last Updated

2026-03-18

Healthy Volunteers

No

Conditions

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

Interventions

DRUG

Tislelizumab

Administered by intravenous infusion

DRUG

BGB-A445

Administered by intravenous infusion

DRUG

LBL-007

Administered by intravenous infusion

DRUG

Carboplatin

Investigator's choice; administered by intravenous infusion

DRUG

Cisplatin

Investigator's choice; administered by intravenous infusion

DRUG

pemetrexed

Investigator's choice; administered by intravenous infusion

DRUG

Paclitaxel

Investigator's choice; administered by intravenous infusion

DRUG

Nab paclitaxel

Investigator's choice; administered by intravenous infusion

DRUG

BGB-15025

Administered Orally

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.

Locations (61)

Valkyrie Clinical Trials

Los Angeles, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, United States

Providence Portland Medical Center

Portland, Oregon, United States

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, Australia

Chris Obrien Lifehouse

Camperdown, New South Wales, Australia

Northern Beaches Hospital

Frenchs Forest, New South Wales, Australia

Port Macquarie Base Hospital

Port Macquarie, New South Wales, Australia

One Clinical Research

Nedlands, Western Australia, Australia

St John of God Health Care

Subiaco, Western Australia, 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, Canada

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

The Fifth Medical Center of Chinese Pla General Hospital

Beijing, Beijing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Affiliated Hospital of Hebei University

Baoding, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Nantong Tumor Hospital Branch North

Nantong, Jiangsu, China

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Nanchang University Branch Xianghu

Nanchang, Jiangxi, China

Jining No1 Peoples Hospital East Branch

Jining, Shandong, China

Linyi Peoples Hospital

Linyi, Shandong, China

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Shanghai East Hospital Branch Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

Taizhou Hospital of Zhejiang

Taizhou, Zhejiang, China

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

Pulau Pinang Hospital

George Town, Malaysia

Tengku Ampuan Afzan Hospital

Kuantan, Malaysia

Sarawak General Hospital

Kuching, Malaysia

The Institute of Oncology, Arensia Exploratory Medicine

Chisinau, Moldova

Institute of Oncology Bucharest Prof Dr Alexandru Trestioreanu

Bucureti, Romania

Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricu

ClujNapoca, Romania

National Cancer Centre Singapore

Singapore, Singapore

Chungbuk National University Hospital

Cheongju-si, Chungcheongbukdo, South Korea

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do, South Korea

The Catholic University of Korea, St Vincents Hospital

PaldalGu SuwonSi, Gyeonggi-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, South Korea

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, South Korea

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, South Korea

Hospital Universitario Vall Dhebron

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitario Virgen Del Rocio

Seville, Spain

Songklanagarind Hospital (Prince of Songkhla University)

Hat Yai, Thailand

Srinagarind Hospital (Khon Kaen University)

Muang, Thailand

Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)

Muang, Thailand

Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)

Ongkharak, Thailand