Ociperlimab With Tislelizumab and Chemotherapy in Patients With Untreated Metastatic Non-Small Cell Lung Cancer

  • STATUS
    Recruiting
  • End date
    Apr 11, 2024
  • participants needed
    270
  • sponsor
    BeiGene
Updated on 11 July 2022
systemic therapy
measurable disease
chemoradiotherapy
cancer chemotherapy
targeted therapy
adjuvant chemotherapy
lung carcinoma

Summary

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

Details
Condition Locally Advanced, Unresectable, or Metastatic Nonsmall Cell Lung Cancer (NSCLC), Nonsmall Cell Lung Cancer, Stage IV
Treatment Placebo, tislelizumab, Ociperlimab, histology-based chemotherapy
Clinical Study IdentifierNCT05014815
SponsorBeiGene
Last Modified on11 July 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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
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
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
At least one measurable lesion by the investigator per RECIST v1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1

Exclusion Criteria

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
Note: Other protocol defined Inclusion/Exclusion criteria may apply
ROS1
Prior treatment with EGFR inhibitors, ALK inhibitors, or targeted therapy for other
driver mutations
Any prior therapy targeting T-cell costimulation or checkpoint pathways in metastatic NSCLC
Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before randomization
Infection (including tuberculosis infection, etc.) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before randomization
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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