treatment-naive locally advanced, unresectable stage III non-small cell lung cancer (NSCLC)
Conditions
Interventions
investigational material(s)
Generic name etc :
INN of investigational material : tislelizumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational mate
Sponsors
Bristol-Myers Squibb
BeiGene Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCLC. Staging will be confirmed at screening by positron emission tomography-computed tomography (PET/CT) and brain imaging by magnetic resonance imaging (MRI) or computed tomography (CT) with contrast. 2. Eastern Cooperative Oncology Group (ECOG) performance status =< 1. 3. EGFR mutation and ALK gene translocation status available prior to randomization. 4. Provision of fresh or archival tumor tissue or discussion with Sponsor. 5. Adequate hematologic and end-organ function.
Exclusion criteria
Exclusion criteria: 1. Subject has received prior therapies targeting PD-1 or PD-L1, or has received chemotherapy, radiation, targeted therapy, biologic therapy, immunotherapy or investigational agent used to control NSCLC. 2. Subject has a history of severe hypersensitivity reactions to other monoclonal antibodies. 3. Subject has a history of interstitial lung disease or documented ongoing interstitial lung disease or history of pneumonitis that has required oral or intravenous steroid. 4. Subject has any active malignancy =< 2 years before randomization, with the exception of NSCLC and any locally recurring cancer that has been treated curatively (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast). 5. Subject has severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection; Subject has known HIV infection; Subject has untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers, or active hepatitis C; or Subject has active autoimmune disease. 6. Subject has had prior allogeneic stem cell transplantation or organ transplantation. 7. Subject has significant cardiovascular disease or other condition which places the patient at risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy progression free survival (PFS) | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy overall survival (OS) OS at 24 months objective response rate (ORR) duration of response (DoR) proportion of subjects alive and progression-free at 12 months (APF12) etc. | — |
Countries
Asia except Japan, Europe, Japan, North America, South America
Outcome results
None listed