A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT05635708 |
Recruitment Status :
Recruiting
First Posted : December 2, 2022
Last Update Posted : April 25, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non-small Cell Lung Cancer Metastatic Non-small Cell Lung Cancer | Drug: Tislelizumab Drug: BGB-A445 Drug: LBL-007 Drug: Carboplatin Drug: Cisplatin Drug: pemetrexed Drug: Paclitaxel Drug: Nab paclitaxel Drug: BGB-15025 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 400 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | March 7, 2023 |
Estimated Primary Completion Date : | July 2025 |
Estimated Study Completion Date : | July 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: Sub-study 1: Experimental Arm 1A
Tislelizumab + BGB-A445
|
Drug: Tislelizumab
Administered by intravenous infusion Drug: BGB-A445 Administered by intravenous infusion |
Experimental: Sub-study 1: Experimental Arm 2A
Tislelizumab + LBL-007
|
Drug: Tislelizumab
Administered by intravenous infusion Drug: LBL-007 Administered by intravenous infusion |
Experimental: Sub-study 1: Experimental Arm 3A
Tislelizumab + BGB-15025
|
Drug: Tislelizumab
Administered by intravenous infusion Drug: BGB-15025 Administered Orally |
Experimental: Sub-study 1: Reference Arm Tislelizumab alone
Tislelizumab alone
|
Drug: Tislelizumab
Administered by intravenous infusion |
Experimental: Sub-study 2: Experimental Arm 1B
Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445
|
Drug: Tislelizumab
Administered by intravenous infusion Drug: BGB-A445 Administered by intravenous infusion Drug: Carboplatin Investigator's choice; administered by intravenous infusion Drug: Cisplatin Investigator's choice; administered by intravenous infusion Drug: pemetrexed Investigator's choice; administered by intravenous infusion Drug: Paclitaxel Investigator's choice; administered by intravenous infusion Drug: Nab paclitaxel Investigator's choice; administered by intravenous infusion |
Experimental: Sub-study 2: Experimental Arm 2B
Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007
|
Drug: Tislelizumab
Administered by intravenous infusion Drug: LBL-007 Administered by intravenous infusion Drug: Carboplatin Investigator's choice; administered by intravenous infusion Drug: Cisplatin Investigator's choice; administered by intravenous infusion Drug: pemetrexed Investigator's choice; administered by intravenous infusion Drug: Paclitaxel Investigator's choice; administered by intravenous infusion Drug: Nab paclitaxel Investigator's choice; administered by intravenous infusion |
Experimental: Sub-study 2: Experimental Arm 3B
Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025
|
Drug: Tislelizumab
Administered by intravenous infusion Drug: Carboplatin Investigator's choice; administered by intravenous infusion Drug: Cisplatin Investigator's choice; administered by intravenous infusion Drug: pemetrexed Investigator's choice; administered by intravenous infusion Drug: Paclitaxel Investigator's choice; administered by intravenous infusion Drug: Nab paclitaxel Investigator's choice; administered by intravenous infusion Drug: BGB-15025 Administered Orally |
Active Comparator: Sub-study 2: Reference Arm
Tislelizumab + investigator's choice of histology-appropriate chemotherapy
|
Drug: Tislelizumab
Administered by intravenous infusion Drug: Carboplatin Investigator's choice; administered by intravenous infusion Drug: Cisplatin Investigator's choice; administered by intravenous infusion Drug: pemetrexed Investigator's choice; administered by intravenous infusion Drug: Paclitaxel Investigator's choice; administered by intravenous infusion Drug: Nab paclitaxel Investigator's choice; administered by intravenous infusion |
- Confirmed overall response rate (ORR) [ Time Frame: Up to 3 Years ]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
- Progression-free survival (PFS) [ Time Frame: Up to 3 Years ]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) [ Time Frame: Up to 3 Years ]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) [ Time Frame: Up to 3 Years ]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) [ Time Frame: Up to 3 Years ]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) [ Time Frame: Up to 3 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.
- Plasma or serum concentrations of tislelizumab [ Time Frame: Up to 30 days after last dose ]
- Plasma or serum concentrations of BGB-A445 [ Time Frame: Up to 30 days after last dose ]
- Plasma or serum concentrations of LBL-007 [ Time Frame: Up to 30 days after last dose ]
- Number of participants with anti-drug antibodies (ADAs) to tislelizumab [ Time Frame: Up to 30 days after last dose ]
- Number of participants with anti-drug antibodies (ADAs) to LBL-007 [ Time Frame: Up to 30 days after last dose ]
- Number of participants with anti-drug antibodies (ADAs) to BGB-A445 [ Time Frame: Up to 30 days after last dose ]
- Number of participants with anti-drug antibodies (ADAs) to BGB-15025 [ Time Frame: Up to 30 days after last dose ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
- 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.
- 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.
- At least 1 measurable lesion as defined per RECIST v1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion Criteria:
- Has mixed small cell lung cancer.
- 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.
- 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.
- Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before randomization/enrollment.
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active autoimmune diseases.
NOTE: Other protocol and sub-study protocol defined criteria may apply
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05635708
Contact: BeiGene | +1-877-828-5568 | clinicaltrials@beigene.com |
Study Director: | Study Director | BeiGene |
Responsible Party: | BeiGene |
ClinicalTrials.gov Identifier: | NCT05635708 |
Other Study ID Numbers: |
BGB-LC-201 CTR20230892 ( Other Identifier: ChinaDrugTrials ) |
First Posted: | December 2, 2022 Key Record Dates |
Last Update Posted: | April 25, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Non-small Cell Lung Cancer NSCLC programmed cell death protein-1 PD-L1 Low Tumors |
PD-L1 Negative Tumors Metastatic Non-Small Cell Lung Cancer PD-L1 High Tumors |
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel Albumin-Bound Paclitaxel Carboplatin |
Pemetrexed Tislelizumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Immunological |