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

BeiGene

Status and phase: Terminated; Phase 3

Conditions: Non-small Cell Lung Cancer; NSCLC

Treatments: Drug: Placebo; Drug: Pembrolizumab; Drug: Tislelizumab; Drug: Ociperlimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04746924

AdvanTIG-302

2023-507317-10-00 (EU Trial (CTIS) Number)

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 high levels of programmed cell death ligand-1 (PD-L1), locally advanced/recurrent or untreated metastatic non-small cell lung cancer (NSCLC).

Enrollment: 669 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 Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
6. Eastern Cooperative Oncology Group (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

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669 participants in 4 patient groups, including a placebo group

Arm A: Ociperlimab plus Tislelizumab

Experimental group

Description:

Participants received ociperlimab 900 mg and tislelizumab 200 mg intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.

Treatment:

Drug: Ociperlimab

Drug: Tislelizumab

Arm B: Pembrolizumab plus Placebo

Active Comparator group

Description:

Participants received pembrolizumab 200 mg and placebo intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.

Treatment:

Drug: Placebo

Drug: Pembrolizumab

Arm C: Tislelizumab plus Placebo

Placebo Comparator group

Description:

Participants received tislelizumab 200 mg and placebo intravenously every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.

Treatment:

Drug: Tislelizumab

Drug: Placebo

Safety Run-In Substudy

Experimental group

Description:

Japanese participants received ociperlimab 900 mg and tislelizumab 200 mg every 3 weeks. Treatment continued until lack of benefit, unacceptable toxicity, or withdrawal for other reasons.

Treatment:

Drug: Ociperlimab

Drug: Tislelizumab