A Study of Tislelizumab in Combination With Investigational Agents in Participants With Non-Small Cell Lung Cancer
Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small Cell Lung Cancer, NSCLC, programmed cell death protein-1, PD-L1 Low Tumors, PD-L1 Negative Tumors, Metastatic Non-Small Cell Lung Cancer, PD-L1 High Tumors
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed NSCLC (nonsquamous or squamous) that is locally advanced or recurrent and not eligible for curative surgery and/or definitive chemoradiotherapy, or metastatic NSCLC. No prior systemic treatment given as primary therapy for metastatic NSCLC. Prior adjuvant/neoadjuvant chemotherapy or definitive chemoradiation/adjuvant radiotherapy for locally advanced disease is allowed provided the last dose of chemotherapy and/or radiotherapy occurred at least 6 months before randomization/enrollment. Evaluable tumor PD-L1 expression as determined by a local laboratory or by central laboratory on archival tumor tissue or fresh biopsy. Patients with unknown PD-L1 expression will not be eligible for this study. At least 1 measurable lesion as defined per RECIST v1.1. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. Exclusion Criteria: Has mixed small cell lung cancer. Participants with known actionable mutations for which a targeted therapy has been approved by the local health authority will be excluded. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-LAG-3 or any other antibody or drug targeting T-cell costimulation or immune checkpoint pathways. Note: Patients who received prior neoadjuvant, adjuvant or immuno-oncology therapies targeting PD-1 or PD-L1 in consolidation are eligible, if there has been a treatment-free interval of ≥ 6 months from last dose of immuno-oncology therapy prior to radiologic recurrence of disease. Has received any Chinese herbal medicine or Chinese patent medicines used to control cancer ≤ 14 days before randomization/enrollment. Active leptomeningeal disease or uncontrolled, untreated brain metastasis, or active autoimmune diseases. NOTE: Other protocol and sub-study protocol defined criteria may apply
Sites / Locations
- California Cancer Associates For Research and Excellence, Ccare EncinitasRecruiting
- Valkyrie Clinical TrialsRecruiting
- Memorial Sloan Kettering Cancer Center MskccRecruiting
- Blacktown Cancer and Haematology CentreRecruiting
- Chris Obrien LifehouseRecruiting
- Northern Beaches HospitalRecruiting
- Port Macquarie Base HospitalRecruiting
- One Clinical ResearchRecruiting
- St John of God Health CareRecruiting
- The Second Hospital of Anhui Medical UniversityRecruiting
- Fujian Cancer HospitalRecruiting
- Affiliated Hospital of Hebei UniversityRecruiting
- Harbin Medical University Cancer HospitalRecruiting
- Henan Cancer HospitalRecruiting
- Hubei Cancer HospitalRecruiting
- The First Affiliated Hospital of Soochow UniversityRecruiting
- The First Affiliated Hospital of Nanchang University Branch XianghuRecruiting
- Jining No Peoples HospitalRecruiting
- Linyi Peoples HospitalRecruiting
- Shanghai Pulmonary HospitalRecruiting
- Tianjin Medical University Cancer Institute and HospitalRecruiting
- Taizhou Hospital of ZhejiangRecruiting
- Chungbuk National University HospitalRecruiting
- National Cancer CenterRecruiting
- Seoul National University Bundang HospitalRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- The Institute of Oncology, Arensia Exploratory MedicineRecruiting
- National Cancer Centre SingaporeRecruiting
- Srinagarind Hospital (Khon Kaen University)Recruiting
- Hrh Princess Maha Chakri Sirindhorn Medical Center (Srinakharinwirot University)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Active Comparator
Sub-study 1: Experimental Arm 1A
Sub-study 1: Experimental Arm 2A
Sub-study 1: Reference Arm
Sub-study 2 : Experimental Arm 1A
Sub-study 2: Experimental Arm 1B
Sub-study 2: Reference Arm
Tislelizumab + BGB-A445
Tislelizumab + LBL-007
Tislelizumab alone
Tislelizumab + investigator's choice of histology-appropriate chemotherapy + BGB-A445
Tislelizumab + investigator's choice of histology-appropriate chemotherapy + LBL-007
Tislelizumab + investigator's choice of histology-appropriate chemotherapy