Ociperlimab with Tislelizumab and Chemotherapy in Participants with Untreated Metastatic Non-Small Cell Lung Cancer

BeiGene

Status and phase: Completed; Phase 2

Conditions: Nonsmall Cell Lung Cancer, Stage IV; Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC)

Treatments: Drug: Tislelizumab; Drug: histology-based chemotherapy; Drug: Placebo; Drug: Ociperlimab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05014815

CTR20212782 (Other Identifier)

AdvanTIG-205

2021-001075-17 (EudraCT Number)

Details and patient eligibility

About

This is a randomized investigator and participant blinded, sponsor unblinded, multicenter study that evaluates the safety and efficacy of ociperlimab with tislelizumab and histology-based chemotherapy compared with treatment with tislelizumab and histology-based chemotherapy in participants with previously untreated locally advanced, unresectable, or metastatic NSCLC

Enrollment: 272 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 NSCLC that is not eligible for curative surgery and/or definitive radiotherapy, with or without chemotherapy, or metastatic non-squamous or squamous NSCLC.

2. No prior systemic therapy for locally advanced or metastatic squamous or non-squamous NSCLC, including but not limited to chemotherapy or targeted therapy. Participants who have received prior neoadjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of chemotherapy and/or concurrent radiotherapy prior to randomization.

3. Archival tumor tissue or fresh biopsy (if archival tissue is not available) for the determination of PD-L1 levels and retrospective analyses of other biomarkers. Only participantswho have evaluable PD-L1 results are eligible.

4. At least one measurable lesion by the investigator per RECIST v1.1.

   .

5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.

Key Exclusion Criteria:

1. Known mutations in:

   • EGFR gene Note: For non-squamous NSCLC, articipants with unknown EGFR mutation status will be required to have a tissue-based EGFR test either locally or at the central laboratory before enrollment, or endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)-based EGFR test locally. Participants found to have EGFR-sensitizing mutations will be excluded.
   • ALK fusion oncogene.
   • BRAF V600E
   • ROS1

2. Prior treatment with EGFR inhibitors, ALK inhibitors, or targeted therapy for other driver mutations.

3. Any prior therapy targeting T-cell costimulation or checkpoint pathways in metastatic NSCLC.

4. Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization.

5. Infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before randomization.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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272 participants in 2 patient groups, including a placebo group

Arm A: Ociperlimab + tislelizumab histology-based chemotherapy

Experimental group

Treatment:

Drug: Ociperlimab

Drug: histology-based chemotherapy

Drug: Tislelizumab

Arm B: Placebo + tislelizumab + histology-based chemotherapy

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: histology-based chemotherapy

Drug: Tislelizumab