A Phase 3, Randomized, Open-Label Study to Compare Ociperlimab (BGB-A1217) Plus Tislelizumab (BGB-A317) Versus Durvalumab in Patients With Locally Advanced, Unresectable, PD-L1-Selected Non-Small Cell Lung Cancer Whose Disease Has Not Progressed After Concurrent Chemoradiotherapy
Description
Brief Summary
The primary objective of this study is to compare progression-free survival (PFS) between Arm
A (ociperlimab in combination with tislelizumab) and Arm C (Durvalumab) as assessed by the
Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors Version
1.1 (RECIST v1.1) in participants with stage III unresectable PD-L1-selected non-small cell
lung cancer whose disease has not progressed after cCRT.
Phase
N/AInclusion and Exclusion Criteria
- Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place).
- Participant has histologically or cytologically confirmed, locally advanced, unresectable Stage III NSCLC (AJCC Cancer Staging Manual 2017, derived from IASLC) prior to initiation of cCRT.
- Participant must have completed at least 2 cycles of platinum-based chemotherapy concurrent with radiotherapy
- Participants must have not experienced PD following definitive, platinum-based cCRT.
- Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1.
- Participants must have adequate organ function
- Agree to provide archival tissue (formalin-fixed paraffin-embedded block containing tumor [preferred] or approximately 6 to 15 freshly cut unstained slides) or fresh biopsy obtained prior to cCRT (if archival tissue is not available) for prospective central evaluation of PD-L1 levels and retrospective analysis of other biomarkers. Key
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT, or any other antibody or drugs specifically targeting T-cell co-stimulation or checkpoint pathways.
- Diagnosed with NSCLC that harbors an epidermal growth factor receptor (EGFR) sensitizing mutation, anaplastic lymphoma kinase (ALK) gene translocation, ROS1 gene translocation or RET gene rearrangement.
- Participants who received systemic anticancer treatment besides the specified cCRT.
- Any unresolved toxicity CTCAE > Grade 2 from the prior cCRT.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone [in Japan, prednisolone] or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment.
- Infection (including tuberculosis infection, etc) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before the first dose of study treatment. Note: Antiviral therapy is permitted for participants with chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. NOTE: Other protocol Inclusion/Exclusion criteria may apply.
Sites
Please contact the trial administrator to learn more about where you can participate in this trial. Please use the contact form on the right side.
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