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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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BeiGene

Status and phase

Enrolling
Phase 2

Conditions

Metastatic Non-small Cell Lung Cancer
Non-small Cell Lung Cancer

Treatments

Drug: pemetrexed
Drug: LBL-007
Drug: Tislelizumab
Drug: Cisplatin
Drug: BGB-15025
Drug: BGB-A445
Drug: Carboplatin
Drug: Nab paclitaxel
Drug: Paclitaxel

Study type

Interventional

Funder types

Industry

Identifiers

NCT05635708
CTR20230892 (Other Identifier)
2022-502738-18-00 (EU Trial (CTIS) Number)
BGB-LC-201

Details and patient eligibility

About

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%).

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

400 participants in 8 patient groups

Sub-study 1: Experimental Arm 1A
Experimental group
Description:
Tislelizumab + BGB-A445
Treatment:
Drug: BGB-A445
Drug: Tislelizumab
Sub-study 1: Experimental Arm 2A
Experimental group
Description:
Tislelizumab + LBL-007
Treatment:
Drug: LBL-007
Drug: Tislelizumab
Sub-study 1: Experimental Arm 3A
Experimental group
Description:
Tislelizumab + BGB-15025
Treatment:
Drug: BGB-15025
Drug: Tislelizumab
Sub-study 1: Reference Arm Tislelizumab alone
Experimental group
Description:
Tislelizumab alone
Treatment:
Drug: Tislelizumab
Sub-study 2: Experimental Arm 1B
Experimental group
Description:
Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445
Treatment:
Drug: Paclitaxel
Drug: Nab paclitaxel
Drug: Carboplatin
Drug: BGB-A445
Drug: Cisplatin
Drug: pemetrexed
Drug: Tislelizumab
Sub-study 2: Experimental Arm 2B
Experimental group
Description:
Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007
Treatment:
Drug: Paclitaxel
Drug: Nab paclitaxel
Drug: Carboplatin
Drug: Cisplatin
Drug: pemetrexed
Drug: LBL-007
Drug: Tislelizumab
Sub-study 2: Experimental Arm 3B
Experimental group
Description:
Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-15025
Treatment:
Drug: Paclitaxel
Drug: Nab paclitaxel
Drug: Carboplatin
Drug: BGB-15025
Drug: Cisplatin
Drug: pemetrexed
Drug: Tislelizumab
Sub-study 2: Reference Arm
Active Comparator group
Description:
Tislelizumab + investigator's choice of histology-appropriate chemotherapy
Treatment:
Drug: Paclitaxel
Drug: Nab paclitaxel
Drug: Carboplatin
Drug: Cisplatin
Drug: pemetrexed
Drug: Tislelizumab

Trial contacts and locations

64

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Central trial contact

BeiGene

Data sourced from clinicaltrials.gov

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