A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
- Conditions
- Non-small Cell Lung CancerMetastatic Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05635708
- Lead Sponsor
- BeiGene
- 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%).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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.
Key
-
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.
-
Use of Chinese herbal medicines or Chinese patent medicines intended for cancer control within 14 days prior to randomization/enrollment.
-
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sub-study 1: Arm 1A Tislelizumab Tislelizumab + BGB-A445 Sub-study 1: Arm 1A BGB-A445 Tislelizumab + BGB-A445 Sub-study 1: Arm 2A Tislelizumab Tislelizumab + LBL-007 Sub-study 1: Arm 2A LBL-007 Tislelizumab + LBL-007 Sub-study 1: Arm 3A Tislelizumab Tislelizumab + BGB-15025 Sub-study 1: Arm 3A BGB-15025 Tislelizumab + BGB-15025 Sub-study 1: Reference Arm Tislelizumab alone Tislelizumab Tislelizumab alone Sub-study 2: Arm 1B Tislelizumab Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445 Sub-study 2: Arm 1B BGB-A445 Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445 Sub-study 2: Arm 1B Carboplatin Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445 Sub-study 2: Arm 1B Cisplatin Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445 Sub-study 2: Arm 1B pemetrexed Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445 Sub-study 2: Arm 1B Paclitaxel Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445 Sub-study 2: Arm 1B Nab paclitaxel Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445 Sub-study 2: Arm 2B Tislelizumab Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007 Sub-study 2: Arm 2B LBL-007 Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007 Sub-study 2: Arm 2B Carboplatin Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007 Sub-study 2: Arm 2B Cisplatin Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007 Sub-study 2: Arm 2B pemetrexed Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007 Sub-study 2: Arm 2B Paclitaxel Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007 Sub-study 2: Arm 2B Nab paclitaxel Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007 Sub-study 2: Arm 3B Tislelizumab Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025 Sub-study 2: Arm 3B Carboplatin Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025 Sub-study 2: Arm 3B Cisplatin Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025 Sub-study 2: Arm 3B pemetrexed Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025 Sub-study 2: Arm 3B Paclitaxel Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025 Sub-study 2: Arm 3B Nab paclitaxel Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025 Sub-study 2: Arm 3B BGB-15025 Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025 Sub-study 2: Reference Arm Tislelizumab Tislelizumab + investigator's choice of histology-appropriate chemotherapy Sub-study 2: Reference Arm Carboplatin Tislelizumab + investigator's choice of histology-appropriate chemotherapy Sub-study 2: Reference Arm Cisplatin Tislelizumab + investigator's choice of histology-appropriate chemotherapy Sub-study 2: Reference Arm pemetrexed Tislelizumab + investigator's choice of histology-appropriate chemotherapy Sub-study 2: Reference Arm Paclitaxel Tislelizumab + investigator's choice of histology-appropriate chemotherapy Sub-study 2: Reference Arm Nab paclitaxel Tislelizumab + investigator's choice of histology-appropriate chemotherapy
- Primary Outcome Measures
Name Time Method Confirmed overall response rate (ORR) Up to 6 months 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
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) Up to 1 year 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.
Duration of Response (DOR) Up to 1 year 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
Clinical Benefit Rate (CBR) Up to 6 months 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
Disease Control Rate (DCR) Up to 6 months 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
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 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.
Trial Locations
- Locations (64)
Valkyrie Clinical Trials
🇺🇸Los Angeles, California, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center Mskcc
🇺🇸New York, New York, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Oncology and Hematology Care Clinic Westside
🇺🇸Portland, Oregon, United States
The University of Texas Md Anderson Cancer Center
🇺🇸Houston, Texas, United States
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
Port Macquarie Base Hospital
🇦🇺Port Macquarie, New South Wales, Australia
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