A Phase 3, Randomized, Double-Blind Study of Ociperlimab, an Anti-TIGIT Antibody, in Combination With Tislelizumab Compared to Pembrolizumab in Patients With Previously Untreated, PD-L1-Selected, and Locally Advanced, Unresectable, or Metastatic Non-Small Cell Lung Cancer
Overview
- Phase
- Phase 3
- Intervention
- Tislelizumab
- Conditions
- Non-small Cell Lung Cancer
- Sponsor
- BeiGene
- Enrollment
- 662
- Locations
- 218
- Primary Endpoint
- Overall Survival (OS)
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of ociperlimab + tislelizumab compared with that of pembrolizumab in adults with PD-L1 high, locally advanced/recurrent or untreated metastatic NSCLC.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically or cytologically documented locally advanced or recurrent non-small cell lung cancer (NSCLC) that is not eligible for curative surgery and/or definitive radiotherapy with or without chemoradiotherapy, or metastatic-nonsquamous or squamous NSCLC.
- •No prior systemic treatment for metastatic NSCLC.
- •Agreement to provide archival tissue or fresh biopsy (if archival tissue is not available).
- •Tumors with PD-L1 expressed in ≥ 50% tumor cells.
- •At least 1 measurable lesion as defined per RECIST v1.
- •ECOG Performance Status ≤
Exclusion Criteria
- •Known mutations in the epidermal growth factor receptor (EGFR) gene, anaplastic lymphoma kinase (ALK) fusion oncogene, BRAF V600E, or ROS
- •Prior therapy with an anti-programmed cell death protein (anti-PD)-1, anti-PD-ligand (L)-1, anti-PD-ligand-2, anti-T-cell immunoglobulin and ITIM (anti-TIGIT) domain, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
- •Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- •Active autoimmune diseases or history of autoimmune diseases that may relapse.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply
Arms & Interventions
Arm A: Tislelizumab plus Ociperlimab
Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.
Intervention: Tislelizumab
Arm A: Tislelizumab plus Ociperlimab
Participants will receive tislelizumab 200 milligrams (mg) intravenously followed by ociperlimab 900 mg intravenously once every 3 weeks.
Intervention: Ociperlimab
Arm B: Pembrolizumab plus Placebo
Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Intervention: Pembrolizumab
Arm B: Pembrolizumab plus Placebo
Participants will receive pembrolizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Intervention: Placebo
Arm C: Tislelizumab plus Placebo
Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Intervention: Tislelizumab
Arm C: Tislelizumab plus Placebo
Participants will receive tislelizumab 200 mg intravenously followed by placebo intravenously once every 3 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Overall Survival (OS)
Time Frame: Up to approximately 58 months
OS will be defined as the time from the date of randomization to the date of death due to any cause.
Secondary Outcomes
- Progression-free Survival (PFS) As Assessed By Investigators(Up to approximately 58 months)
- Overall Response Rate (ORR) As Assessed By Investigators(Up to approximately 58 months)
- Duration Of Response (DOR) As Assessed By Investigators(Up to approximately 58 months)
- Health-related Quality Of Life (HRQoL): European Organization For Research And Treatment Of Cancer Quality Of Life Questionnaire Core 30 (EORTC QLQ-C30)(Within 7 days after permanent treatment discontinuation)
- HRQoL: EORTC Lung Cancer Module Quality of Life Questionnaire Lung Cancer 13 (QLQ-LC13) HRQoL will be assessed via PRO using the EORTC QLQ-LC13.(Within 7 days after permanent treatment discontinuation)
- HRQoL: European Quality of Life-5 Level- 5 Dimension (EQ-5D-5L) Questionnaire(Within 7 days after permanent treatment discontinuation)
- Time To Deterioration (TTD)(Within 7 days after permanent treatment discontinuation)
- Number Of Participants Experiencing Adverse Events (AEs)(90 days (±14) after last dose)