Phase 3, Randomized, Open Label Study to Compare Ociperlimab (BGB-A1217) Plus Tislelizumab (BGB-A317) Plus Concurrent Chemoradiotherapy (cCRT) Followed by Ociperlimab Plus Tislelizumab or Tislelizumab Plus cCRT Followed by Tislelizumab Versus cCRT Followed by Durvalumab in Previously Untreated, Locally Advanced, Unresectable Non-Small Cell Lung Cancer
Brief SummaryThe primary objectives of this study is to compare progression free survival (PFS) and complete response rate (CRR) between participants treated with Ociperlimab plus tislelizumab plus Concurrent Chemoradiotherapy (cCRT) followed by Ociperlimab plus tislelizumab versus participants treated with tislelizumab plus Concurrent Chemoradiotherapy (cCRT) followed by tislelizumab versus participants treated with cCRT followed by durvalumab in previously untreated, locally advanced, unresectable non-small cell lung cancer (LA NSCLC) The secondary objective of this study is to compare overall survival (OS) and PFS in programmed cell death protein ligand-1 (PD-L1) positive population between Arm A and C.
Inclusion and Exclusion Criteria
- Age ≥ 18 years on the day of signing the ICF (or the legal age of consent in the jurisdiction in which the study is taking place).
- Participant has newly diagnosed, histologically confirmed, locally advanced, Stage III unresectable NSCLC.
- Measurable disease as assessed by RECIST v1.1.
- Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1.
- Patients must have adequate organ function Key
- Any prior therapy for lung cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, biologic therapy, or immunotherapy.
- Any prior radiotherapy to the thorax, including radiotherapy to the esophagus, mediastinum, or for breast cancer.
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, TIGIT or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
- Diagnosed with NSCLC that harbors an EGFR-sensitizing mutation or ALK gene translocation.
- 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 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: Other protocol Inclusion/Exclusion criteria may apply.
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.