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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05635708




Registration number
NCT05635708
Ethics application status
Date submitted
23/11/2022
Date registered
2/12/2022
Date last updated
23/10/2024

Titles & IDs
Public title
A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
Scientific 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
Secondary ID [1] 0 0
CTR20230892
Secondary ID [2] 0 0
BGB-LC-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Metastatic Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tislelizumab
Treatment: Drugs - BGB-A445
Treatment: Drugs - LBL-007
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin
Treatment: Drugs - pemetrexed
Treatment: Drugs - Paclitaxel
Treatment: Drugs - Nab paclitaxel
Treatment: Drugs - BGB-15025

Experimental: Sub-study 1: Experimental Arm 1A - Tislelizumab + BGB-A445

Experimental: Sub-study 1: Experimental Arm 2A - Tislelizumab + LBL-007

Experimental: Sub-study 1: Experimental Arm 3A - Tislelizumab + BGB-15025

Experimental: Sub-study 1: Reference Arm Tislelizumab alone - Tislelizumab alone

Experimental: Sub-study 2: Experimental Arm 1B - Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445

Experimental: Sub-study 2: Experimental Arm 2B - Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007

Experimental: Sub-study 2: Experimental Arm 3B - Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025

Active comparator: Sub-study 2: Reference Arm - Tislelizumab + investigator's choice of histology-appropriate chemotherapy


Treatment: Drugs: Tislelizumab
Administered by intravenous infusion

Treatment: Drugs: BGB-A445
Administered by intravenous infusion

Treatment: Drugs: LBL-007
Administered by intravenous infusion

Treatment: Drugs: Carboplatin
Investigator's choice; administered by intravenous infusion

Treatment: Drugs: Cisplatin
Investigator's choice; administered by intravenous infusion

Treatment: Drugs: pemetrexed
Investigator's choice; administered by intravenous infusion

Treatment: Drugs: Paclitaxel
Investigator's choice; administered by intravenous infusion

Treatment: Drugs: Nab paclitaxel
Investigator's choice; administered by intravenous infusion

Treatment: Drugs: BGB-15025
Administered Orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Confirmed overall response rate (ORR)
Timepoint [1] 0 0
Up to 3 Years
Secondary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
Up to 3 Years
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to 3 Years
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR)
Timepoint [3] 0 0
Up to 3 Years
Secondary outcome [4] 0 0
Disease Control Rate (DCR)
Timepoint [4] 0 0
Up to 3 Years
Secondary outcome [5] 0 0
Number of participants with adverse events (AEs)
Timepoint [5] 0 0
Up to 3 Years
Secondary outcome [6] 0 0
Plasma or serum concentrations of tislelizumab
Timepoint [6] 0 0
Up to 30 days after last dose
Secondary outcome [7] 0 0
Plasma or serum concentrations of BGB-A445
Timepoint [7] 0 0
Up to 30 days after last dose
Secondary outcome [8] 0 0
Plasma or serum concentrations of LBL-007
Timepoint [8] 0 0
Up to 30 days after last dose
Secondary outcome [9] 0 0
Number of participants with anti-drug antibodies (ADAs) to tislelizumab
Timepoint [9] 0 0
Up to 30 days after last dose
Secondary outcome [10] 0 0
Number of participants with anti-drug antibodies (ADAs) to LBL-007
Timepoint [10] 0 0
Up to 30 days after last dose
Secondary outcome [11] 0 0
Number of participants with anti-drug antibodies (ADAs) to BGB-A445
Timepoint [11] 0 0
Up to 30 days after last dose
Secondary outcome [12] 0 0
Number of participants with anti-drug antibodies (ADAs) to BGB-15025
Timepoint [12] 0 0
Up to 30 days after last dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/07/2025
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA
Recruitment hospital [1] 0 0
Blacktown Cancer and Haematology Centre - Blacktown
Recruitment hospital [2] 0 0
Chris Obrien Lifehouse - Camperdown
Recruitment hospital [3] 0 0
Northern Beaches Hospital - Frenchs Forest
Recruitment hospital [4] 0 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment hospital [5] 0 0
One Clinical Research - Nedlands
Recruitment hospital [6] 0 0
St John of God Health Care - Subiaco
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment postcode(s) [3] 0 0
2086 - Frenchs Forest
Recruitment postcode(s) [4] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
6008 - Subiaco
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Massachusetts
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
Texas
Country [6] 0 0
Brazil
State/province [6] 0 0
Barretos
Country [7] 0 0
Brazil
State/province [7] 0 0
Londrina
Country [8] 0 0
Brazil
State/province [8] 0 0
Porto Alegre
Country [9] 0 0
Brazil
State/province [9] 0 0
Sao Jose do Rio Preto
Country [10] 0 0
Brazil
State/province [10] 0 0
Sao Paulo
Country [11] 0 0
Canada
State/province [11] 0 0
Alberta
Country [12] 0 0
China
State/province [12] 0 0
Anhui
Country [13] 0 0
China
State/province [13] 0 0
Beijing
Country [14] 0 0
China
State/province [14] 0 0
Fujian
Country [15] 0 0
China
State/province [15] 0 0
Hebei
Country [16] 0 0
China
State/province [16] 0 0
Heilongjiang
Country [17] 0 0
China
State/province [17] 0 0
Henan
Country [18] 0 0
China
State/province [18] 0 0
Hubei
Country [19] 0 0
China
State/province [19] 0 0
Jiangsu
Country [20] 0 0
China
State/province [20] 0 0
Jiangxi
Country [21] 0 0
China
State/province [21] 0 0
Shandong
Country [22] 0 0
China
State/province [22] 0 0
Shanghai
Country [23] 0 0
China
State/province [23] 0 0
Shanxi
Country [24] 0 0
China
State/province [24] 0 0
Tianjin
Country [25] 0 0
China
State/province [25] 0 0
Zhejiang
Country [26] 0 0
France
State/province [26] 0 0
Paris
Country [27] 0 0
France
State/province [27] 0 0
SaintHerblain
Country [28] 0 0
Georgia
State/province [28] 0 0
Tbilisi
Country [29] 0 0
Italy
State/province [29] 0 0
Roma
Country [30] 0 0
Italy
State/province [30] 0 0
Verona
Country [31] 0 0
Korea, Republic of
State/province [31] 0 0
Chungcheongbukdo
Country [32] 0 0
Korea, Republic of
State/province [32] 0 0
Gyeonggi-do
Country [33] 0 0
Korea, Republic of
State/province [33] 0 0
Seoul Teugbyeolsi
Country [34] 0 0
Malaysia
State/province [34] 0 0
Georgetown
Country [35] 0 0
Malaysia
State/province [35] 0 0
Kuantan
Country [36] 0 0
Malaysia
State/province [36] 0 0
Kuching
Country [37] 0 0
Moldova, Republic of
State/province [37] 0 0
Chisinau
Country [38] 0 0
Romania
State/province [38] 0 0
Bucharest
Country [39] 0 0
Romania
State/province [39] 0 0
ClujNapoca
Country [40] 0 0
Singapore
State/province [40] 0 0
Singapore
Country [41] 0 0
Spain
State/province [41] 0 0
Barcelona
Country [42] 0 0
Spain
State/province [42] 0 0
Madrid
Country [43] 0 0
Spain
State/province [43] 0 0
Sevilla
Country [44] 0 0
Thailand
State/province [44] 0 0
Hat Yai
Country [45] 0 0
Thailand
State/province [45] 0 0
Muang
Country [46] 0 0
Thailand
State/province [46] 0 0
Ongkharak

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
BeiGene
Address
Country

Ethics approval
Ethics application status

Summary
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%).
Trial website
https://clinicaltrials.gov/study/NCT05635708
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director
Address 0 0
BeiGene
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
BeiGene
Address 0 0
Country 0 0
Phone 0 0
+1-877-828-5568
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05635708