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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
Sponsor:
Information provided by (Responsible Party):
BeiGene

Study Description
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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%).

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 Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  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.

  2. 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

  3. 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

  4. 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

  5. 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.

  6. Plasma or serum concentrations of tislelizumab [ Time Frame: Up to 30 days after last dose ]
  7. Plasma or serum concentrations of BGB-A445 [ Time Frame: Up to 30 days after last dose ]
  8. Plasma or serum concentrations of LBL-007 [ Time Frame: Up to 30 days after last dose ]
  9. Number of participants with anti-drug antibodies (ADAs) to tislelizumab [ Time Frame: Up to 30 days after last dose ]
  10. Number of participants with anti-drug antibodies (ADAs) to LBL-007 [ Time Frame: Up to 30 days after last dose ]
  11. Number of participants with anti-drug antibodies (ADAs) to BGB-A445 [ Time Frame: Up to 30 days after last dose ]
  12. Number of participants with anti-drug antibodies (ADAs) to BGB-15025 [ Time Frame: Up to 30 days after last dose ]

Eligibility Criteria
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Information from the National Library of Medicine

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.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: BeiGene +1-877-828-5568 clinicaltrials@beigene.com

Locations
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Sponsors and Collaborators
BeiGene
Investigators
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Study Director: Study Director BeiGene
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by BeiGene:
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
Additional relevant MeSH terms:
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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