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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05635708
• Other study ID #: BGB-LC-201
• Secondary ID: CTR202308922022-
• Status: Recruiting
• Phase: Phase 2
• Start date: March 7, 2023
• Est. completion date: July 2025

Study information

• Verified date: June 2024
• Source: BeiGene
• Contact: BeiGene
• Phone: +1-877-828-5568
• Email: clinicaltrials[@]beigene.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC.

2. No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy for locally advanced disease is allowed provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months before randomization/enrollment.

3. Evaluable tumor PD-L1 expression as determined by a local laboratory or by central laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1 expression will not be eligible for this study.

4. At least 1 measurable lesion as defined per RECIST v1.1.

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

Exclusion Criteria:

1. Has mixed small cell lung cancer.

2. Participants with known actionable mutations (including but not limited to EGFR, ALK, BRAF, RET, and ROSI mutations) for which a targeted therapy is available per local standard of care.

3. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-LAG-3 or any other antibody or drug targeting T-cell costimulation or immune checkpoint pathways. Note: Patients who received prior neoadjuvant, adjuvant or immuno-oncology therapies targeting PD-1 or PD-L1 in consolidation are eligible, if there has been a treatment-free interval of = 6 months from last dose of immuno-oncology therapy prior to radiologic recurrence of disease.

4. Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer = 14 days before randomization/enrollment.

5. Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active autoimmune diseases.

NOTE: Other protocol and sub-study protocol defined criteria may apply

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Metastatic Non-small Cell Lung Cancer
• Non-small Cell Lung Cancer

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	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	One Clinical Research	Nedlands	Western Australia
Australia	Port Macquarie Base Hospital	Port Macquarie	New South Wales
Australia	St John of God Health Care	Subiaco	Western Australia
Brazil	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	Sao Jose do Rio Preto
Brazil	Icesp Instituto Do Cancer Do Estado de Sao Paulo Octavio Frias de Oliveira	Sao Paulo
Canada	Cross Cancer Institute	Edmonton	Alberta
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	Chinese Pla General Hospital	Beijing	Beijing
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	The Second Hospital of Anhui Medical University	Hefei	Anhui
China	Jining No Peoples Hospital	Jining	Shandong
China	Linyi Peoples Hospital	Linyi	Shandong
China	The First Affiliated Hospital of Nanchang University Branch Xianghu	Nanchang	Jiangxi
China	Nantong Tumor Hospital Branch North	Nantong	Jiangsu
China	Affiliated Zhongshan Hospital of Fudan University	Shanghai	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi
China	Taizhou Hospital of Zhejiang	Taizhou	Zhejiang
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin
China	Hubei Cancer Hospital	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan
France	Institut Curie	Paris
France	Chu Nantes Hopital Nord Laennec	SaintHerblain
Georgia	Arensia Exploratory Medicine Llc	Tbilisi
Italy	Regina Elena, Istituto Nazionale Dei Tumori, Ifo, Irccs	Roma
Italy	Centro Ricerche Cliniche Di Verona	Verona
Korea, Republic of	Chungbuk National University Hospital	Cheongjusi	Chungcheongbukdo
Korea, Republic of	National Cancer Center	Goyangsi	Gyeonggido
Korea, Republic of	Seoul National University Bundang Hospital	Seongnamsi	Gyeonggido
Korea, Republic of	Asan Medical Center	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Samsung Medical Center	Seoul	Seoul Teugbyeolsi
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul	Seoul Teugbyeolsi
Korea, Republic of	The Catholic University of Korea, St Vincents Hospital	Suwonsi	Gyeonggido
Malaysia	Pulau Pinang Hospital	Georgetown
Malaysia	Sultan Ismail Hospital	Johor Bahru
Malaysia	Tengku Ampuan Afzan Hospital	Kuantan
Malaysia	Sarawak General Hospital	Kuching
Malaysia	Beacon Hospital	Petaling Jaya
Moldova, Republic of	The Institute of Oncology, Arensia Exploratory Medicine	Chisinau
Romania	Institute of Oncology Bucharest Prof Dr Alexandru Trestioreanu	Bucharest
Romania	Arensia Research Clinic At the Oncology Institute Prof Dr Ion Chiricu	ClujNapoca
Singapore	National Cancer Centre Singapore	Singapore
Spain	Hospital Universitario Vall Dhebron	Barcelona
Spain	Hospital Universitario de Octubre	Madrid
Spain	Hospital Universitario Virgen Del Rocio	Sevilla
Thailand	Songklanagarind Hospital (Prince of Songkhla University)	Hat Yai
Thailand	Maharaj Nakorn Chiang Mai Hospital (Chiang Mai University)	Muang
Thailand	Srinagarind Hospital (Khon Kaen University)	Muang
Thailand	Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)	Ongkharak
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	The University of Texas Md Anderson Cancer Center	Houston	Texas
United States	Valkyrie Clinical Trials	Los Angeles	California
United States	Memorial Sloan Kettering Cancer Center Mskcc	New York	New York
United States	Oncology and Hematology Care Clinic Westside	Portland	Oregon
United States	Providence Portland Medical Center	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
BeiGene

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 3 Years
Secondary	Progression-free survival (PFS)	PFS is defined as the time from date of randomization, or the first dose for safety lead-in participants , until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.	Up to 3 Years
Secondary	Duration of Response (DOR)	DOR is defined as the time from the first determination of a confirmed response per RECIST v1.1 until the first documentation of progression or death, whichever comes first as assessed by the investigator	Up to 3 Years
Secondary	Clinical Benefit Rate (CBR)	CBR is defined as the percentage of participants with a best overall response of a complete response, partial response, or durable stable disease, as assessed by the investigator using RECIST v1.1	Up to 3 Years
Secondary	Disease Control Rate (DCR)	DCR is defined as the percentage of participants with a best overall response of complete response, partial response, or stable disease, as assessed by the investigator using RECIST v1.1	Up to 3 Years
Secondary	Number of participants with adverse events (AEs)	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results.	Up to 3 Years
Secondary	Plasma or serum concentrations of tislelizumab		Up to 30 days after last dose
Secondary	Plasma or serum concentrations of BGB-A445		Up to 30 days after last dose
Secondary	Plasma or serum concentrations of LBL-007		Up to 30 days after last dose
Secondary	Number of participants with anti-drug antibodies (ADAs) to tislelizumab		Up to 30 days after last dose
Secondary	Number of participants with anti-drug antibodies (ADAs) to LBL-007		Up to 30 days after last dose
Secondary	Number of participants with anti-drug antibodies (ADAs) to BGB-A445		Up to 30 days after last dose
Secondary	Number of participants with anti-drug antibodies (ADAs) to BGB-15025		Up to 30 days after last dose