Overview

This is a randomized investigator and patient 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

Principal investigator

Muhammad Furqan
Internal Medicine

Eligibility 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. Patients 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 patients who have evaluable PD-L1 results are eligible.
  4. At least one measurable lesion by the investigator per RECIST v1.1.

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

Key Exclusion Criteria:

  1. Known mutations in:

    • EGFR gene Note: For non-squamous NSCLC, patients 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. Patients 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.

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For Referring Providers

Do you have a patient you think would be a good candidate for this trial? Learn more about enrolling your patient.

Contact the study coordinator

Muhammad Furqan
Not currently recruiting, contact if interested.