Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC)

Recruiting now · Phase 2

Conditions studied: Stage III NSCLC

In brief

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).

Key facts

Study ID

NCT07264647

Run by

Fondazione Ricerca Traslazionale

People needed

30

Starts

2025-03-27

Expected to finish

2030-02-01

Last updated by the study team

2025-12-04

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Istituti Fisioterapici Ospitalieri — Rome, Roma (RM), Italy (enrolling)

Full record on ClinicalTrials.gov

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