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

NCT05635708 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: BGB-LC-201CTR202308922022-502738-18-00
• Study Type: interventional
• Target: 400
• Locations: 15 countries
• Sites: 61

Brief 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%).

Conditions

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

Keywords

Non-small Cell Lung Cancer; NSCLC; programmed cell death protein-1; PD-L1 Low Tumors; PD-L1 Negative Tumors; Metastatic Non-Small Cell Lung Cancer; PD-L1 High Tumors

Outcome Measures

Primary Outcomes (1)

• Confirmed overall response rate (ORR)

  ORR is defined as the percentage of participants with partial or complete response, as assessed by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1

  Up to 6 months

Secondary Outcomes (5)

• Progression-free survival (PFS)

  Up to 1 year

• Duration of Response (DOR)

  Up to 1 year

• Clinical Benefit Rate (CBR)

  Up to 6 months

• Disease Control Rate (DCR)

  Up to 6 months

• Number of participants with adverse events (AEs)

  From the first dose of study drug(s) to 90 days after initiation of new anticancer therapy, death, withdrawal of consent, or loss to follow-up, whichever occurs first, up to approximately 2 years

Study Arms (8)

Sub-study 1: Arm 1A

EXPERIMENTAL

Tislelizumab + BGB-A445

Drug: Tislelizumab; Drug: BGB-A445

Sub-study 1: Arm 2A

EXPERIMENTAL

Tislelizumab + LBL-007

Drug: Tislelizumab; Drug: LBL-007

Sub-study 1: Arm 3A

EXPERIMENTAL

Tislelizumab + BGB-15025

Drug: Tislelizumab; Drug: BGB-15025

Sub-study 1: Reference Arm Tislelizumab alone

ACTIVE COMPARATOR

Tislelizumab alone

Drug: Tislelizumab

Sub-study 2: Arm 1B

EXPERIMENTAL

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

Drug: Tislelizumab; Drug: BGB-A445; Drug: Carboplatin; Drug: Cisplatin; Drug: pemetrexed; Drug: Paclitaxel; Drug: Nab paclitaxel

Sub-study 2: Arm 2B

EXPERIMENTAL

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

Drug: Tislelizumab; Drug: LBL-007; Drug: Carboplatin; Drug: Cisplatin; Drug: pemetrexed; Drug: Paclitaxel; Drug: Nab paclitaxel

Sub-study 2: Arm 3B

EXPERIMENTAL

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

Drug: Tislelizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: pemetrexed; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: BGB-15025

Sub-study 2: Reference Arm

ACTIVE COMPARATOR

Tislelizumab + investigator's choice of histology-appropriate chemotherapy

Drug: Tislelizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: pemetrexed; Drug: Paclitaxel; Drug: Nab paclitaxel

Interventions

Tislelizumab DRUG

Administered by intravenous infusion

Sub-study 1: Arm 1A; Sub-study 1: Arm 2A; Sub-study 1: Arm 3A; Sub-study 1: Reference Arm Tislelizumab alone; Sub-study 2: Arm 1B; Sub-study 2: Arm 2B; Sub-study 2: Arm 3B; Sub-study 2: Reference Arm

BGB-A445 DRUG

Administered by intravenous infusion

Sub-study 1: Arm 1A; Sub-study 2: Arm 1B

LBL-007 DRUG

Administered by intravenous infusion

Sub-study 1: Arm 2A; Sub-study 2: Arm 2B

Carboplatin DRUG

Investigator's choice; administered by intravenous infusion

Sub-study 2: Arm 1B; Sub-study 2: Arm 2B; Sub-study 2: Arm 3B; Sub-study 2: Reference Arm

Cisplatin DRUG

Investigator's choice; administered by intravenous infusion

Sub-study 2: Arm 1B; Sub-study 2: Arm 2B; Sub-study 2: Arm 3B; Sub-study 2: Reference Arm

pemetrexed DRUG

Investigator's choice; administered by intravenous infusion

Sub-study 2: Arm 1B; Sub-study 2: Arm 2B; Sub-study 2: Arm 3B; Sub-study 2: Reference Arm

Paclitaxel DRUG

Investigator's choice; administered by intravenous infusion

Sub-study 2: Arm 1B; Sub-study 2: Arm 2B; Sub-study 2: Arm 3B; Sub-study 2: Reference Arm

Nab paclitaxel DRUG

Investigator's choice; administered by intravenous infusion

Sub-study 2: Arm 1B; Sub-study 2: Arm 2B; Sub-study 2: Arm 3B; Sub-study 2: Reference Arm

BGB-15025 DRUG

Administered Orally

Sub-study 1: Arm 3A; Sub-study 2: Arm 3B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• 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.
• At least one measurable lesion, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.

You may not qualify if:

• Diagnosis of mixed small cell lung cancer.
• 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
• Participants with nonsquamous NSCLC and unknown EGFR mutation status must undergo local testing. Those found to have EGFR-sensitizing mutations will be excluded.
• 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
• 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.

Sponsors & Collaborators

• BeiGene: lead

Study Sites (61)

Valkyrie Clinical Trials

Los Angeles, California, 90067-2011, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Memorial Sloan Kettering Cancer Center Mskcc

New York, New York, 10065-6800, United States

Location

Providence Portland Medical Center

Portland, Oregon, 97213-2933, United States

Location

The University of Texas Md Anderson Cancer Center

Houston, Texas, 77030-4009, United States

Location

Blacktown Cancer and Haematology Centre

Blacktown, New South Wales, NSW 2148, Australia

Location

Chris Obrien Lifehouse

Camperdown, New South Wales, NSW 2050, Australia

Location

Northern Beaches Hospital

Frenchs Forest, New South Wales, NSW 2086, Australia

Location

Port Macquarie Base Hospital

Port Macquarie, New South Wales, NSW 2444, Australia

Location

One Clinical Research

Nedlands, Western Australia, WA 6009, Australia

Location

St John of God Health Care

Subiaco, Western Australia, WA 6008, Australia

Location

Hospital de Amor Barretos

Barretos, 14784-400, Brazil

Location

Hospital Do Cancer de Londrina

Londrina, 86015-520, Brazil

Location

Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

Porto Alegre, 90110-270, Brazil

Location

Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto

São José do Rio Preto, 15090-000, Brazil

Location

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

São Paulo, 01246-000, Brazil

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

The Second Hospital of Anhui Medical University

Hefei, Anhui, 230601, China

Location

The Fifth Medical Center of Chinese Pla General Hospital

Beijing, Beijing Municipality, 100071, China

Location

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Affiliated Hospital of Hebei University

Baoding, Hebei, 071000, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

Location

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

Location

Nantong Tumor Hospital Branch North

Nantong, Jiangsu, 226000, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

The First Affiliated Hospital of Nanchang University Branch Xianghu

Nanchang, Jiangxi, 332000, China

Location

Jining No1 Peoples Hospital East Branch

Jining, Shandong, 272002, China

Location

Linyi Peoples Hospital

Linyi, Shandong, 276000, China

Location

Affiliated Zhongshan Hospital of Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai East Hospital Branch Hospital

Shanghai, Shanghai Municipality, 200123, China

Location

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 030013, China

Location

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Taizhou Hospital of Zhejiang

Taizhou, Zhejiang, 317000, China

Location

Institut Curie

Paris, 75005, France

Location

Chu Nantes Hopital Nord Laennec

SaintHerblain, 44805, France

Location

Arensia Exploratory Medicine Llc

Tbilisi, 0112, Georgia

Location

Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs

Roma, 00144, Italy

Location

Centro Ricerche Cliniche Di Verona

Verona, 37126, Italy

Location

Pulau Pinang Hospital

George Town, 10450, Malaysia

Location

Tengku Ampuan Afzan Hospital

Kuantan, 25100, Malaysia

Location

Sarawak General Hospital

Kuching, 93586, Malaysia

Location

The Institute of Oncology, Arensia Exploratory Medicine

Chisinau, 2025, Moldova

Location

Institute of Oncology Bucharest Prof Dr Alexandru Trestioreanu

Bucureti, 022328, Romania

Location

Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricu

ClujNapoca, 400015, Romania

Location

National Cancer Centre Singapore

Singapore, 168583, Singapore

Location

Chungbuk National University Hospital

Cheongju-si, Chungcheongbukdo, 28644, South Korea

Location

National Cancer Center (Korea)

IlsandongGu GoyangSi, Gyeonggi-do, 10408, South Korea

Location

The Catholic University of Korea, St Vincents Hospital

PaldalGu SuwonSi, Gyeonggi-do, 16247, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Samsung Medical Center

GangnamGu, Seoul Teugbyeolsi, 06351, South Korea

Location

Severance Hospital Yonsei University Health System

SeodaemunGu, Seoul Teugbyeolsi, 03722, South Korea

Location

Asan Medical Center

SongpaGu, Seoul Teugbyeolsi, 05505, South Korea

Location

Hospital Universitario Vall Dhebron

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Virgen Del Rocio

Seville, 41013, Spain

Location

Songklanagarind Hospital (Prince of Songkhla University)

Hat Yai, 90110, Thailand

Location

Srinagarind Hospital (Khon Kaen University)

Muang, 40002, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)

Muang, 50200, Thailand

Location

Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)

Ongkharak, 26120, Thailand

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

tislelizumab; Carboplatin; Cisplatin; Pemetrexed; Paclitaxel; Taxes

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations

Study Officials

• Study Director

  BeiGene

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 2, 2022
• Study Start: March 7, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

BR (5); MY (3); ES (3); AU (6); CN (18); GE (1); CA (1); MO (1); SG (1); RO (2); KR (7); FR (2); US (5); TH (4); IT (2)