NCT07264647 Neoadjuvant Chemo-immunotherapy for Stage III PD-L1 Positive Non-Small Cell Lung Cancer (NSCLC)
| NCT ID | NCT07264647 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fondazione Ricerca Traslazionale |
| Condition | Stage III NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-27 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2025-03-27 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: 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.
Contact & Investigator
Federico Cappuzzo
PRINCIPAL INVESTIGATOR
Istituti Fisioterapici Ospitalieri
Frequently Asked Questions
Who can join the NCT07264647 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Stage III NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07264647 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07264647 currently recruiting?
Yes, NCT07264647 is actively recruiting participants. Contact the research team at federico.cappuzzo@fondazionefort.org for enrollment information.
Where is the NCT07264647 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT07264647 clinical trial?
NCT07264647 is sponsored by Fondazione Ricerca Traslazionale. The principal investigator is Federico Cappuzzo at Istituti Fisioterapici Ospitalieri. The trial plans to enroll 30 participants.