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The phase II Study is to explore the efficacy and safety of Tislelizumab as consolidation therapy in patients with locally advanced non-small cell lung cancer who have not progressed following neoadjuvant chemotherapy plus Tislelizumab ± Bevacizumab and definitive concurrent chemoradiation therapy.
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Inclusion criteria
For inclusion in neoadjuvant therapy, patients should fulfil the following criteria:
Exclusion criteria
Exclusion criteria for enrolment for neoadjuvant therapy Patients should not enter the study if any of the following exclusion criteria are fulfilled:
Exclusion criteria for concurrent chemoradiation following neoadjuvant therapy
Patients should not enter the concurrent chemoradiation phase if any of the following exclusion criteria are fulfilled:
Patients who develop disease progression and the irradiation dose of normal tissue will exceed the limit as defined in Section 7.
World Health Organization (WHO) Performance Status of 2-4;
Inadequate organ and marrow function as defined below:
Forced expiratory volume in 1 second (FEV1) <800ml
Absolute neutrophil count <1.5 x 109/L (1500 per mm3)
Platelets <100 x 109/L (100,000 per mm3)
Haemoglobin<9.0 g/dL (5.59 mmol/L)
Serum creatinine CL <50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976)
Serum bilirubin >1.5 x upper limit of normal (ULN).
Aspartate Transaminase(AST) and Alanine Transaminase(ALT) >2.5 x ULN
Patients should not enter the Tislelizumab consolidation if any of the following exclusion criteria are fulfilled:
Primary purpose
Allocation
Interventional model
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116 participants in 2 patient groups
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Central trial contact
Bo Qiu, MD; DaQuan Wang, MD
Data sourced from clinicaltrials.gov
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