The trial is taking place at:
H

Hospital Universitario Virgen de la Victoria | Cardiology Department

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A Study of Ociperlimab With Tislelizumab Compared to Pembrolizumab in Participants With Untreated Lung Cancer

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Status and phase

Enrolling
Phase 3

Conditions

Non-small Cell Lung Cancer
NSCLC

Treatments

Drug: Placebo
Drug: Tislelizumab
Drug: Pembrolizumab
Drug: Ociperlimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04746924
AdvanTIG-302
BGB-A317-A1217-302 (Other Identifier)
CTR20211476/CTR20211464 (Other Identifier)
2020-004985-21 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with PD-L1 high, locally advanced/recurrent or untreated metastatic NSCLC.

Enrollment

660 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria: 1. Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC. 2. No prior systemic treatment for metastatic NSCLC. 3. Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available). 4. Tumors with PD-L1 expressed in ≥ 50% tumor cells. 5. At least 1 measurable lesion as defined per RECIST v1.1. 6. ECOG Performance Status ≤ 1. Key Exclusion Criteria: 1. Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS1. 2. Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways. 3. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. 4. Active autoimmune diseases or history of autoimmune diseases that may relapse. Note: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

660 participants in 3 patient groups, including a placebo group

Arm A: Tislelizumab plus Ociperlimab
Experimental group
Description:
Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.
Treatment:
Drug: Ociperlimab
Drug: Tislelizumab
Arm B: Pembrolizumab plus Placebo
Active Comparator group
Description:
Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Treatment:
Drug: Pembrolizumab
Drug: Placebo
Arm C: Tislelizumab plus Placebo
Placebo Comparator group
Description:
Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Treatment:
Drug: Tislelizumab
Drug: Placebo

Trial contacts and locations

108

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Central trial contact

BeiGene

Data sourced from clinicaltrials.gov

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