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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

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: Arm 1A - Tislelizumab + BGB-A445

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

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

Active comparator: Sub-study 1: Reference Arm Tislelizumab alone - Tislelizumab alone

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

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

Experimental: Sub-study 2: 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 6 months
Secondary outcome [1] 0 0
Progression-free survival (PFS)
Timepoint [1] 0 0
Up to 1 year
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to 1 year
Secondary outcome [3] 0 0
Clinical Benefit Rate (CBR)
Timepoint [3] 0 0
Up to 6 months
Secondary outcome [4] 0 0
Disease Control Rate (DCR)
Timepoint [4] 0 0
Up to 6 months
Secondary outcome [5] 0 0
Number of participants with adverse events (AEs)
Timepoint [5] 0 0
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

Eligibility
Key inclusion criteria
Key

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

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
Active, not 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
1/10/2025
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
Johor Bahru
Country [36] 0 0
Malaysia
State/province [36] 0 0
Kuantan
Country [37] 0 0
Malaysia
State/province [37] 0 0
Kuching
Country [38] 0 0
Malaysia
State/province [38] 0 0
Petaling Jaya
Country [39] 0 0
Moldova, Republic of
State/province [39] 0 0
Chisinau
Country [40] 0 0
Romania
State/province [40] 0 0
Bucureti
Country [41] 0 0
Romania
State/province [41] 0 0
ClujNapoca
Country [42] 0 0
Singapore
State/province [42] 0 0
Singapore
Country [43] 0 0
Spain
State/province [43] 0 0
Barcelona
Country [44] 0 0
Spain
State/province [44] 0 0
Madrid
Country [45] 0 0
Spain
State/province [45] 0 0
Sevilla
Country [46] 0 0
Thailand
State/province [46] 0 0
Hat Yai
Country [47] 0 0
Thailand
State/province [47] 0 0
Muang
Country [48] 0 0
Thailand
State/province [48] 0 0
Ongkharak

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05635708