Overview
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
Principal investigator
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. 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.
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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, 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.
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.
For Referring Providers
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