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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
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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
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Secondary ID [1]
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CTR20230892
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Secondary ID [2]
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BGB-LC-201
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer
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Metastatic Non-small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Confirmed overall response rate (ORR)
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Assessment method [1]
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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
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Timepoint [1]
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Up to 3 Years
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Secondary outcome [1]
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Progression-free survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to 3 Years
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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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
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Timepoint [2]
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Up to 3 Years
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Secondary outcome [3]
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Clinical Benefit Rate (CBR)
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Assessment method [3]
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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
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Timepoint [3]
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Up to 3 Years
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Secondary outcome [4]
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Disease Control Rate (DCR)
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Assessment method [4]
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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
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Timepoint [4]
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Up to 3 Years
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Secondary outcome [5]
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Number of participants with adverse events (AEs)
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Assessment method [5]
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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.
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Timepoint [5]
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Up to 3 Years
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Secondary outcome [6]
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Plasma or serum concentrations of tislelizumab
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Assessment method [6]
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Timepoint [6]
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Up to 30 days after last dose
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Secondary outcome [7]
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Plasma or serum concentrations of BGB-A445
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Assessment method [7]
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Timepoint [7]
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Up to 30 days after last dose
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Secondary outcome [8]
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Plasma or serum concentrations of LBL-007
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Assessment method [8]
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Timepoint [8]
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Up to 30 days after last dose
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Secondary outcome [9]
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Number of participants with anti-drug antibodies (ADAs) to tislelizumab
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Assessment method [9]
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Timepoint [9]
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Up to 30 days after last dose
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Secondary outcome [10]
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Number of participants with anti-drug antibodies (ADAs) to LBL-007
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Assessment method [10]
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0
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Timepoint [10]
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Up to 30 days after last dose
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Secondary outcome [11]
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Number of participants with anti-drug antibodies (ADAs) to BGB-A445
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Assessment method [11]
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Timepoint [11]
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Up to 30 days after last dose
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Secondary outcome [12]
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Number of participants with anti-drug antibodies (ADAs) to BGB-15025
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Assessment method [12]
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Timepoint [12]
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Up to 30 days after last dose
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/03/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/07/2025
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Blacktown Cancer and Haematology Centre - Blacktown
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Recruitment hospital [2]
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Chris Obrien Lifehouse - Camperdown
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Recruitment hospital [3]
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Northern Beaches Hospital - Frenchs Forest
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Recruitment hospital [4]
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Port Macquarie Base Hospital - Port Macquarie
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Recruitment hospital [5]
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One Clinical Research - Nedlands
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Recruitment hospital [6]
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St John of God Health Care - Subiaco
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2050 - Camperdown
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Recruitment postcode(s) [3]
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2086 - Frenchs Forest
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Recruitment postcode(s) [4]
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2444 - Port Macquarie
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment postcode(s) [6]
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6008 - Subiaco
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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United States of America
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State/province [2]
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Massachusetts
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United States of America
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New York
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United States of America
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Oregon
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United States of America
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Texas
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Brazil
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State/province [6]
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Barretos
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Brazil
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Londrina
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Brazil
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Porto Alegre
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Brazil
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Sao Jose do Rio Preto
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Brazil
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Sao Paulo
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Canada
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Alberta
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China
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Anhui
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China
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Beijing
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China
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Fujian
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China
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Hebei
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China
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Heilongjiang
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China
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Henan
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China
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Hubei
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China
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Jiangsu
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China
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Jiangxi
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China
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Shandong
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China
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Shanghai
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China
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Shanxi
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China
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Tianjin
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China
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Zhejiang
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France
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Paris
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France
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SaintHerblain
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Georgia
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Tbilisi
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Roma
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Italy
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Verona
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Korea, Republic of
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Chungcheongbukdo
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Gyeonggi-do
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Korea, Republic of
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Seoul Teugbyeolsi
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Georgetown
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Kuching
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Petaling Jaya
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Moldova, Republic of
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Chisinau
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Romania
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Bucharest
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Romania
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ClujNapoca
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Singapore
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Singapore
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sevilla
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Thailand
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Hat Yai
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Thailand
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Muang
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Thailand
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State/province [48]
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Ongkharak
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
BeiGene
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Address
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Country
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Ethics approval
Ethics application status
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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%).
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Trial website
https://clinicaltrials.gov/study/NCT05635708
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Study Director
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Address
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BeiGene
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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BeiGene
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Address
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Country
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Phone
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+1-877-828-5568
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
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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