A Phase II Trial 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
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.
• For inclusion in neoadjuvant therapy, patients should fulfil the following criteria:
‣ Provision of signed, written and dated informed consent prior to any study specific procedures;
⁃ Male or female aged 18\
∙ 75 years old;
⁃ Patients must have histologically- or cytologically-documented NSCLC who present with locally advanced (Stage III) disease;
⁃ Without prior chemotherapy, radiotherapy, surgery, targeted therapy or immunotherapy;
⁃ A recent tumour biopsy (taken following completion of the most recent therapy) is an optional requirement, provided that a biopsy procedure is technically feasible and the procedure is not associated with unacceptable clinical risk;
⁃ Life expectancy ≥12 weeks;
⁃ World Health Organization (WHO) Performance Status of 0 or 1;
⁃ Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients within 14 days before the use of study drug (HCG has a minimum sensitivity of 25 IU/L or equivalent);
⁃ Women must be non-breastfeeding
⁃ 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 clearance(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