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

NCT07264647 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-12-04

No results posted yet for this study

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).

Conditions

  • Stage III NSCLC

Interventions

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

Sponsors & Collaborators

  • Fondazione Ricerca Traslazionale

    lead OTHER

Principal Investigators

  • Federico Cappuzzo · Istituti Fisioterapici Ospitalieri

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-27
Primary Completion
2028-02-01
Completion
2030-02-01

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07264647 on ClinicalTrials.gov