NCT07264647

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Fondazione Ricerca Traslazionale · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Study Population: Adult smoker (past or current) patients diagnosed with stage III (NON T4 for a nodule in a different lobe) NSCLC without driver molecular alterations (EGFR, ALK, ROS1). Treatment: Patients will receive neoadjuvant chemo-immunotherapy based on NSCLC histology. Diagnostic Assessments: All patients will undergo a comprehensive disease staging, including contrast-enhanced chest CT, PET-CT, and contrast-enhanced brain magnetic resonance imaging. A pathological assessment of the mediastinum and lymph-node stations clinically positive/suspected is mandatory. Treatment Cycles: Eligible patients will receive 3 cycles of neoadjuvant chemo- immunotherapy, followed by a comprehensive diagnostic assessment using chest CT and PET-CT and pathologic lymph-node reassessment. Intervention: Patients with pathologic negativization of lymph nodes after neoadjuvant therapy will be candidate for surgery. Patients with pathologic persistence of N2 or N3 disease will be candidate for definitive concurrent chemoradiation as part of routine clinical practice. After local therapy, patients will receive 1 year of adjuvant or maintenance tislelizumab.

Conditions

• Stage III NSCLC

Interventions

Type	Name	Description
DRUG	Tislelizumab	Compared to clinical practice in Italy this trial is adding a neoadjuvant chemoimmuno treatment with adjuvant immuno
PROCEDURE	surgery (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
RADIATION	Chemoradiotherapy	if patient not resectable after neoadjuvant treatment, chemoradiotherapy performed

Timeline

• Start date: 2025-03-27
• Primary completion: 2028-02-01
• Completion: 2030-02-01
• First posted: 2025-12-04
• Last updated: 2025-12-04

Locations

1 site across 1 country: Italy