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Closed (no longer recruiting)Last updated: 9 January 2024

This phase II trial is testing the safety and effectiveness of a new targeted therapy, given in combination with another type of targeted therapy and chemotherapy, for the treatment of people with non-small cell lung cancers that have spread to other parts of the bodyA Phase 2, Randomized, Double-blind Study of Ociperlimab (BGB A1217) and Tislelizumab With Chemotherapy in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Without Sensitizing EGFR or ALK Mutations Who Have Received No Previous Treatment for Metastatic Disease

Clinical summary

Summary

Eligible participants will be randomised into one of two arms of the study. Participants enrolled in the experimental arm will receive intravenous Ociperlimab, in combination with tislelizumab and histology-based chemotherapy. Participants enrolled in the comparator arm will receive a placebo (instead of receiving Ociperlimab), tislelizumab and histology-based chemotherapy.

Conditions

This trial is treating patients with non-small cell lung cancer.

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II

More information

Trial Identifiers

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Trial sponsor

BeiGene Australia Pty Ltd

Scientific Title

A Phase 2, Randomized, Double-blind Study of Ociperlimab (BGB A1217) and Tislelizumab With Chemotherapy in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC) Without Sensitizing EGFR or ALK Mutations Who Have Received No Previous Treatment for Metastatic Disease

Eligibility

Inclusion

  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.

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

Exclusion

  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.

Inclusion

  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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