Optic

ID

Name

AdvanTIG-302

Description

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.

Trial arms

Arm 1

Arm A

Sample size

275

Intervention

OCI + TIS

Dosage information

OCI 900 mg, TIS 200 mg

Dosage schedule

Every three weeks (Q3W)

Population

Adult (≥ 18 years), Previously untreated, Locally advanced, unresectable or metastatic NSCLC, No EGFR or ALK mutations, PD-L1 expression ≥ 50%, No prior checkpoint inhibitor therapy, PD-L1 expression, treatment-naïve

Arm 2

Arm B

Sample size

275

Intervention

PEM + placebo

Dosage information

PEM 200 mg, placebo

Dosage schedule

Every three weeks (Q3W)

Population

Adult (≥ 18 years), Previously untreated, Locally advanced, unresectable or metastatic NSCLC, No EGFR or ALK mutations, PD-L1 expression ≥ 50%, No prior checkpoint inhibitor therapy, PD-L1 expression, treatment-naïve

Arm 3

Arm C

Sample size

55

Intervention

TIS + placebo

Dosage information

TIS 200 mg, placebo

Dosage schedule

Every three weeks (Q3W)

Population

Adult (≥ 18 years), Previously untreated, Locally advanced, unresectable or metastatic NSCLC, No EGFR or ALK mutations, PD-L1 expression ≥ 50%, No prior checkpoint inhibitor therapy

Arm 4

Arm A

Sample size

275

Intervention

OCI + TIS

Dosage information

OCI 900 mg, TIS 200 mg

Dosage schedule

Every three weeks (Q3W)

Population

Adult (≥ 18 years), Previously untreated, Locally advanced, unresectable or metastatic NSCLC, No EGFR or ALK mutations, PD-L1 expression ≥ 50%, No prior checkpoint inhibitor therapy, PD-L1 expression, treatment-naïve

Arm 5

Arm B

Sample size

275

Intervention

PEM + placebo

Dosage information

PEM 200 mg, placebo

Dosage schedule

Every three weeks (Q3W)

Population

Adult (≥ 18 years), Previously untreated, Locally advanced, unresectable or metastatic NSCLC, No EGFR or ALK mutations, PD-L1 expression ≥ 50%, No prior checkpoint inhibitor therapy, PD-L1 expression, treatment-naïve

Arm 6

Arm C

Sample size

55

Intervention

TIS + placebo

Dosage information

TIS 200 mg, placebo

Dosage schedule

Every three weeks (Q3W)

Population

Adult (≥ 18 years), Previously untreated, Locally advanced, unresectable or metastatic NSCLC, No EGFR or ALK mutations, PD-L1 expression ≥ 50%, No prior checkpoint inhibitor therapy, PD-L1 expression, treatment-naïve

Arm 7

Arm A

Sample size

275

Intervention

OCI + TIS

Dosage information

OCI 900 mg, TIS 200 mg

Dosage schedule

Every three weeks (Q3W)

Population

Adult (≥ 18 years), Previously untreated, Locally advanced, unresectable or metastatic NSCLC, No EGFR or ALK mutations, PD-L1 expression ≥ 50%, No prior checkpoint inhibitor therapy, PD-L1 expression, treatment-naïve

Arm 8

Arm A

Sample size

275

Intervention

OCI + TIS

Dosage information

OCI 900 mg, TIS 200 mg

Dosage schedule

Every three weeks (Q3W)

Population

Adult (≥ 18 years), Previously untreated, Locally advanced, unresectable or metastatic NSCLC, No EGFR or ALK mutations, PD-L1 expression ≥ 50%, No prior checkpoint inhibitor therapy, PD-L1 expression, treatment-naïve

Arm 9

Arm B

Sample size

275

Intervention

PEM + placebo

Dosage information

PEM 200 mg, placebo

Dosage schedule

Every three weeks (Q3W)

Population

Adult (≥ 18 years), Previously untreated, Locally advanced, unresectable or metastatic NSCLC, No EGFR or ALK mutations, PD-L1 expression ≥ 50%, No prior checkpoint inhibitor therapy, PD-L1 expression, treatment-naïve

Arm 10

Arm C

Sample size

55

Intervention

TIS + placebo

Dosage information

TIS 200 mg, placebo

Dosage schedule

Every three weeks (Q3W)

Population

Adult (≥ 18 years), Previously untreated, Locally advanced, unresectable or metastatic NSCLC, No EGFR or ALK mutations, PD-L1 expression ≥ 50%, No prior checkpoint inhibitor therapy, PD-L1 expression, treatment-naïve

Trial start

2021-06-08

Estimated PCD

2026-04-01

Trial end

2026-10-01

Status

Recruiting

Phase

Early phase I

Treatment

Tislelizumab

Tislelizumab is a monoclonal antibody formulated for intravenous injection.

Arms:

Arm A: Tislelizumab plus Ociperlimab, Arm C: Tislelizumab plus Placebo

Other names:

BGB-A317

Ociperlimab

Ociperlimab is a monoclonal antibody formulated for intravenous injection.

Arms:

Arm A: Tislelizumab plus Ociperlimab

Other names:

BGB-A1217

Pembrolizumab

Pembrolizumab is a monoclonal antibody formulated for intravenous injection.

Arms:

Arm B: Pembrolizumab plus Placebo

Other names:

KEYTRUDA

Placebo

Placebo infusions will consist of a sterile, normal saline solution.

Arms:

Arm B: Pembrolizumab plus Placebo, Arm C: Tislelizumab plus Placebo

Size

660

Primary endpoint

Overall Survival (OS)

Up to approximately 58 months

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 660, 'type': 'ESTIMATED'}}

Updated at

2024-03-04

Product

Indication

Indication

Product

Product

Organization

Product

A Phase 3, Randomized, Double-Blind Study of Ociperlimab, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer