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).
Study Population: Adult smoker (past or current) patients diagnosed with stage III (NON T4 for a nodule in a different lobe) NSCLC without driver molecular alterations (EGFR, ALK, ROS1). Treatment: Patients will receive neoadjuvant chemo-immunotherapy based on NSCLC histology. Diagnostic Assessments: All patients will undergo a comprehensive disease staging, including contrast-enhanced chest CT, PET-CT, and contrast-enhanced brain magnetic resonance imaging. A pathological assessment of the mediastinum and lymph-node stations clinically positive/suspected is mandatory. Treatment Cycles: Eligible patients will receive 3 cycles of neoadjuvant chemo- immunotherapy, followed by a comprehensive diagnostic assessment using chest CT and PET-CT and pathologic lymph-node reassessment. Intervention: Patients with pathologic negativization of lymph nodes after neoadjuvant therapy will be candidate for surgery. Patients with pathologic persistence of N2 or N3 disease will be candidate for definitive concurrent chemoradiation as part of routine clinical practice. After local therapy, patients will receive 1 year of adjuvant or maintenance tislelizumab.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Compared to clinical practice in Italy this trial is adding a neoadjuvant chemoimmuno treatment with adjuvant immuno
surgery if resectable after neoadjuvant treatment
if patient not resectable after neoadjuvant treatment, chemoradiotherapy performed
Istituti Fisioterapici Ospitalieri
Rome, Roma (RM), Italy
RECRUITINGradical 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.
Time frame: 3 years
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