RecruitingPhase 2NCT07264647
Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC)
Sponsor
Fondazione Ricerca Traslazionale
Enrollment
30 participants
Start Date
Mar 27, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Min Age: 18 YearsMax Age: 99 Years
Inclusion Criteria15
- 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.
- Mandatory baseline multidisciplinary assessment to confirm suitability of patient to local treatment with curative intent.
- Pulmonary function tests within 6 months of the planned resection.
- At least 1 measurable lesion as defined by RECIST v1.1.
- ECOG Performance Status ≤ 1.
- Eligibility to receive a platinum doublet chemotherapy regimen.
- Adequate organ function as indicated by the following laboratory values obtained ≤ 14 days before the first dose of study drug:
- Patients must not have required blood transfusion or growth factor support ≤ 14 days before sample collection at screening for the following:
- Absolute neutrophil count ≥ 1.5 x 109 /L Platelets ≥ 75 x 109 /L Hemoglobin ≥ 90 g/L Estimated glomerular filtration rate ≥ 45 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation (Appendix 9).
- For patients intended to receive cisplatin: creatinine clearance 60mL/min For patients intended to receive carboplatin: creatinine clearance 45mL/min Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) (total bilirubin must be \< 3 x ULN for patients with Gilberts syndrome).
- AST and ALT ≤ 2.5 x ULN For patients not receiving therapeutic anticoagulation: international normalized ratio or activated partial thromboplastin time 1.5ULN
- Age ≥ 18 years.
- Written informed consent.
Exclusion Criteria8
- Evidence of stage IV NSCLC (metastatic disease).
- 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.
- Active autoimmune diseases or history of autoimmune diseases that may recur.
- Concomitant participation in another therapeutic clinical trial.
- Pregnancy or breastfeeding.
Interventions
DRUGTislelizumab
Compared to clinical practice in Italy this trial is adding a neoadjuvant chemoimmuno treatment with adjuvant immuno
PROCEDUREsurgery (any volume) and / or pharmaceuticals treatment initiated or planned or only dynamic observation, in accordance with current clinical guidelines
surgery if resectable after neoadjuvant treatment
RADIATIONChemoradiotherapy
if patient not resectable after neoadjuvant treatment, chemoradiotherapy performed
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07264647