A Ph.2, single-arm, monocentric, trial of neo-adjiuvant chemo-immunotherapy for stage III, PD-L1 positive, NSCLC.
Adults and smokers (past or current) diagnosed with stage III NSCLC without driver molecular alterations (EGFR, ALK, ROS1, RET).
Histologically confirmed stage III disease.
PD-L1 TPS ≥ 1% according to local testing.
No evidence of EGFR mutations or ALK or ROS1 or RET rearrangements by local testing.
Pulmonary function tests within 6 months of the planned resection.
Histology of large cell neuroendocrine carcinoma (LCNEC).
Any previous therapy for current lung cancer, including chemotherapy or radiation therapy.
Previous treatment with an antibody or drug against the immune checkpoint pathway, including but not limited to, therapeutic anti-cytotoxic T-lymphocyte antigen-4-associated antibodies (anti-CTLA-4), anti-PD-1 and anti-PD-L1.
Never smoking patients.
Single group
Tislelizumab
DrugCompared to clinical practice in Italy this trial is adding a neoadjuvant chemoimmuno treatment with adjuvant immuno
surgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
Procedure/Surgerysurgery if resectable after neoadjuvant treatment
Chemoradiotherapy
Radiationif patient not resectable after neoadjuvant treatment, chemoradiotherapy performed
radical surgery (R0) in patients with stage III PD-L1 positive
To evaluate the rate of radical surgery (R0) in patients with stage III PD-L1 positive NSCLC treated with tislelizumab plus platinum-based doublet chemotherapy as neoadjuvant treatment.
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