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
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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