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

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving chemo-immunotherapy (chemotherapy plus an immune-boosting drug) before surgery — followed by more treatment after surgery — can improve outcomes for people with stage III non-small cell lung cancer (NSCLC) whose tumors express a protein called PD-L1. **You may be eligible if...** - You are 18 or older - You have stage III NSCLC confirmed by tissue biopsy - Your tumor tests positive for PD-L1 (at least 1% of cells) - Your tumor does not have EGFR, ALK, ROS1, or RET gene changes (which would make other targeted drugs more appropriate) - You are considered fit enough to receive platinum-based chemotherapy and potentially surgery - You have never smoked, or you are a current or former smoker (note: never-smokers are excluded — see below) **You may NOT be eligible if...** - Your cancer has spread to other parts of the body (stage IV) - You have previously received any cancer treatment for this lung cancer - You have previously received immune checkpoint therapy (anti-PD-1, anti-PD-L1, or anti-CTLA-4) - You have active autoimmune disease - You have never smoked (never-smokers are excluded from this trial) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Istituti Fisioterapici Ospitalieri

Rome, Roma (RM), Italy

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NCT07264647


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