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

Last updated: June 20, 2025
Sponsor: BeiGene
Overall Status: Active - Not Recruiting

Phase

2

Condition

Non-small Cell Lung Cancer

Treatment

Tislelizumab

LBL-007

Nab paclitaxel

Clinical Study ID

NCT05635708
BGB-LC-201
2022-502738-18-00
CTR20230892
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Key Inclusion Criteria:

  1. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC),including nonsquamous or squamous subtypes, that is either locally advanced orrecurrent and not eligible for curative surgery and/or definitive chemoradiotherapy,or metastatic NSCLC.

  2. No prior systemic therapy administered as the primary treatment for metastaticNSCLC. Prior adjuvant or neoadjuvant chemotherapy, definitive chemoradiation, oradjuvant radiotherapy for locally advanced disease is permitted, provided the lastdose of chemotherapy and/or radiotherapy occurred at least 6 months prior torandomization/enrollment.

  3. Tumor programmed death-ligand 1 (PD-L1) expression must be evaluable, as determinedby 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 SolidTumors (RECIST) version 1.1.

  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

Exclusion

Key Exclusion Criteria:

  1. Diagnosis of mixed small cell lung cancer.

  2. Known genomic alterations for which effective targeted therapies are availableaccording 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

  1. Participants with nonsquamous NSCLC and unknown EGFR mutation status must undergolocal testing. Those found to have EGFR-sensitizing mutations will be excluded.

  2. 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

  1. Participants previously treated with these agents in a neoadjuvant, adjuvant, orconsolidation setting may be eligible if a treatment-free interval of at least 6months has elapsed since the last dose and radiologic evidence of recurrence ispresent.

  2. Use of Chinese herbal medicines or Chinese patent medicines intended for cancercontrol within 14 days prior to randomization/enrollment.

  3. Presence of active leptomeningeal disease, untreated or uncontrolled brainmetastases, or active autoimmune disease.

Note: Additional protocol-defined and sub-study-specific criteria may apply.

Study Design

Total Participants: 400
Treatment Group(s): 9
Primary Treatment: Tislelizumab
Phase: 2
Study Start date:
March 07, 2023
Estimated Completion Date:
October 31, 2025

Connect with a study center

  • Blacktown Cancer and Haematology Centre

    Blacktown, New South Wales 2148
    Australia

    Site Not Available

  • Chris Obrien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Northern Beaches Hospital

    Frenchs Forest, New South Wales 2086
    Australia

    Site Not Available

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales 2444
    Australia

    Site Not Available

  • Port Macquarie Base Hospital

    Port Macquarie,, New South Wales 2444
    Australia

    Site Not Available

  • One Clinical Research

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • St John of God Health Care

    Subiaco, Western Australia 6008
    Australia

    Site Not Available

  • Hospital de Amor Barretos

    Barretos, 14784-400
    Brazil

    Site Not Available

  • Hospital Do Cancer de Londrina

    Londrina, 86015-520
    Brazil

    Site Not Available

  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    Porto Alegre, 90110-270
    Brazil

    Site Not Available

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

    Sao Jose Do Rio Preto, 15090-000
    Brazil

    Site Not Available

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

    Sao Paulo, 01246-000
    Brazil

    Site Not Available

  • Cross Cancer Institute

    Edmonton, Alberta T6G 1Z2
    Canada

    Site Not Available

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui 230601
    China

    Site Not Available

  • Chinese Pla General Hospital

    Beijing, Beijing 100853
    China

    Active - Recruiting

  • The Fifth Medical Center of Chinese Pla General Hospital

    Beijing, Beijing 100071
    China

    Site Not Available

  • Fujian Cancer Hospital

    Fuzhou, Fujian 350014
    China

    Site Not Available

  • Affiliated Hospital of Hebei University

    Baoding, Hebei 071000
    China

    Site Not Available

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang 150000
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • Hubei Cancer Hospital

    Wuhan, Hubei 430079
    China

    Site Not Available

  • Nantong Tumor Hospital Branch North

    Nantong, Jiangsu 226000
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University Branch Xianghu

    Nanchang, Jiangxi 332000
    China

    Site Not Available

  • Jining No Peoples Hospital

    Jining, Shandong 272000
    China

    Active - Recruiting

  • Jining No Peoples Hospital East Branch

    Jining, Shandong 272002
    China

    Site Not Available

  • Linyi Peoples Hospital

    Linyi, Shandong 276000
    China

    Site Not Available

  • Affiliated Zhongshan Hospital of Fudan University

    Shanghai, Shanghai 200032
    China

    Site Not Available

  • Shanghai East Hospital Branch Hospital

    Shanghai, Shanghai 200123
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai 200433
    China

    Site Not Available

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi 030013
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin 300060
    China

    Site Not Available

  • Taizhou Hospital of Zhejiang

    Taizhou, Zhejiang 317000
    China

    Site Not Available

  • Institut Curie

    Paris, 75005
    France

    Site Not Available

  • Chu Nantes Hopital Nord Laennec

    SaintHerblain, 44805
    France

    Site Not Available

  • Arensia Exploratory Medicine Llc

    Tbilisi, 0112
    Georgia

    Site Not Available

  • Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs

    Roma, 00144
    Italy

    Site Not Available

  • Centro Ricerche Cliniche Di Verona

    Verona, 37126
    Italy

    Site Not Available

  • Chungbuk National University Hospital

    Cheongjusi, Chungcheongbukdo 28644
    Korea, Republic of

    Site Not Available

  • Chungbuk National University Hospital

    SeowonGu CheongjuSi, Chungcheongbukdo 28644
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    BundangGu SeongnamSi, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyangsi, Gyeonggi-do 10408
    Korea, Republic of

    Active - Recruiting

  • National Cancer Center (Korea)

    Goyangsi, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • National Cancer Center (Korea)

    IlsandongGu GoyangSi, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, St Vincents Hospital

    PaldalGu SuwonSi, Gyeonggi-do 16247
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnamsi, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, St Vincents Hospital

    Suwonsi, Gyeonggi-do 16247
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    SeodaemunGu, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul Teugbyeolsi 03722
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    SongpaGu, Seoul Teugbyeolsi 05505
    Korea, Republic of

    Site Not Available

  • Pulau Pinang Hospital

    Georgetown, 10450
    Malaysia

    Site Not Available

  • Sultan Ismail Hospital

    Johor Bahru, 81100
    Malaysia

    Site Not Available

  • Tengku Ampuan Afzan Hospital

    Kuantan, 25100
    Malaysia

    Site Not Available

  • Sarawak General Hospital

    Kuching, 93586
    Malaysia

    Site Not Available

  • Beacon Hospital

    Petaling Jaya, 46050
    Malaysia

    Site Not Available

  • The Institute of Oncology, Arensia Exploratory Medicine

    Chisinau, 2025
    Moldova, Republic of

    Site Not Available

  • Institute of Oncology Bucharest Prof Dr Alexandru Trestioreanu

    Bucharest, RO-022328
    Romania

    Site Not Available

  • Institute of Oncology Bucharest Prof Dr Alexandru Trestioreanu

    Bucureti, 022328
    Romania

    Site Not Available

  • Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricu

    ClujNapoca, 400015
    Romania

    Site Not Available

  • Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricuta

    ClujNapoca, 400015
    Romania

    Site Not Available

  • National Cancer Centre Singapore

    Singapore, 168583
    Singapore

    Site Not Available

  • Hospital Universitario Vall Dhebron

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Universitario de Octubre

    Madrid, 28041
    Spain

    Site Not Available

  • Hospital Universitario Virgen Del Rocio

    Sevilla, 41013
    Spain

    Site Not Available

  • Songklanagarind Hospital (Prince of Songkhla University)

    Hat Yai, 90110
    Thailand

    Site Not Available

  • Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)

    Muang, 50200
    Thailand

    Site Not Available

  • Srinagarind Hospital (Khon Kaen University)

    Muang, 40002
    Thailand

    Site Not Available

  • Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)

    Ongkharak, 26120
    Thailand

    Site Not Available

  • California Cancer Associates For Research and Excellence, Ccare Encinitas

    Encinitas, California 92024
    United States

    Site Not Available

  • Valkyrie Clinical Trials

    Los Angeles, California 90067-2011
    United States

    Site Not Available

  • Hoag Memorial Presbyterian

    Newport, California 92663
    United States

    Site Not Available

  • Hoag Memorial Presbyterian

    Newport Beach, California 92663-4162
    United States

    Site Not Available

  • California Cancer Associates For Research and Excellence, Inc

    San Marcos, California 92069
    United States

    Site Not Available

  • Dana Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center Basking Ridge

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Msk Basking Ridge

    Basking Ridge, New Jersey 07920
    United States

    Site Not Available

  • Msk Monmouth

    Middletown, New Jersey 07748
    United States

    Site Not Available

  • Msk Bergen

    Montvale, New Jersey 07645
    United States

    Site Not Available

  • Msk Commack

    Commack, New York 11725
    United States

    Site Not Available

  • Msk Westchester

    Harrison, New York 10604
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center Mskcc

    New York, New York 10065-6800
    United States

    Site Not Available

  • Msk Nassau

    Uniondale, New York 11553
    United States

    Site Not Available

  • Oncology and Hematology Care Clinic Westside

    Portland, Oregon 97225-9722
    United States

    Site Not Available

  • Providence Oncology and Hematology Care - Westside

    Portland, Oregon 97225-9722
    United States

    Active - Recruiting

  • Providence Portland Medical Center

    Portland, Oregon 97213-2933
    United States

    Site Not Available

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas 77030-4009
    United States

    Site Not Available

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