Actively Recruiting
Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC)
Led by Fondazione Ricerca Traslazionale · Updated on 2025-12-04
30
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Baseline multidisciplinary assessment confirming suitability for curative treatment
- Pulmonary function tests within 6 months before planned surgery
- At least 1 measurable lesion as defined by RECIST v1.1
- ECOG Performance Status 1
- Eligible to receive platinum doublet chemotherapy
- Adequate organ function with specific blood test criteria within 14 days before first study drug dose
- Absolute neutrophil count 1.5 x 10^9/L, platelets 75 x 10^9/L, hemoglobin 90 g/L
- Estimated glomerular filtration rate 45 mL/min/1.73 m2
- Creatinine clearance 60 mL/min for cisplatin or 45 mL/min for carboplatin
- Serum total bilirubin = 1.5 x upper limit of normal (ULN), with exceptions for Gilbert's syndrome
- AST and ALT = 2.5 x ULN
- INR or activated partial thromboplastin time 1.5 ULN if not on anticoagulation
- Age 18 years
- Written informed consent
You will not qualify if you...
- 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
- Previous treatment with immune checkpoint inhibitors (anti-CTLA-4, anti-PD-1, anti-PD-L1)
- Never smokers
- Active autoimmune diseases or history of autoimmune diseases that may recur
- Participation in another therapeutic clinical trial
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Istituti Fisioterapici Ospitalieri
Rome, Roma (RM), Italy, 00144
Actively Recruiting
Research Team
F
Federico Cappuzzo, Medical Oncology
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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