A Study to Compare Ociperlimab Plus Tislelizumab Versus Durvalumab Following Concurrent Chemoradiotherapy (cCRT) in Participants With Stage III Unresectable Non-Small Cell Lung Cancer
The purpose of this study was to evaluate the safety and efficacy of ociperlimab in combination with tislelizumab compared to durvalumab in adults with stage III unresectable PD-L1-selected non-small cell lung cancer whose disease has not progressed after cCRT.
Checked against the public recordLast updated Oct 31, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- BeiGene
- Interventions being studied
- Drug: Tislelizumab; Drug: Durvalumab; Drug: Ociperlimab; Drug: Chemotherapy; Radiation: Radiotherapy
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: 1. 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). 2. 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. 3. Participant must have completed at least 2 cycles of platinum-based chemotherapy concurrent with radiotherapy 4. Participants must have not experienced PD following definitive, platinum-based cCRT. 5. Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1. 6. Participants must have adequate organ function 7. 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 Exclusion Criteria: 1. 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. 2. 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. 3. Participants who received systemic anticancer treatment besides the specified cCRT. 4. Any unresolved toxicity CTCAE \> Grade 2 from the prior cCRT. 5. Active autoimmune diseases or history of autoimmune diseases that may relapse. 6. 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. 7. 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- XCancer/Centeral Care CenterBolivar, Missouri
- Southern Medical Day Care CentreWollongong, New South Wales
- Townsville HospitalDouglas, Queensland
- Lyell McEwin HospitalElizabeth Vale, South Australia
- Royal Hobart HospitalHobart, Tasmania
- Cabrini HospitalMalvern, Victoria
- Gold Coast University HospitalGold Coast
- Hollywood Private HospitalPerth
- Beijing Cancer HospitalBeijing, Beijing Municipality
- Chongqing University Cancer HospitalChongqing, Chongqing Municipality
- Fujian Cancer HospitalFuzhou, Fujian
- Nanfang Hospital of Southern Medical UniversityGuangzhou, Guangdong
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 31, 2024. Always confirm current availability with the study team.