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Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer: A Pilot Study
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Summary
The SAVED LUNG study is a pilot Phase I trial evaluating safety and feasibility of observation versus standard-of-care surgery in operable Stage II-III (excluding N3) NSCLC patients (PD-L1 ≥50%) who achieve complete clinical response following neoadjuvant platinum-doublet chemotherapy and immunotherapy. Participants are randomized to observation or surgery after rigorous restaging, with primary endpoints focusing on safety and feasibility. Secondary objectives include rates of cross-over to surgery, event-free survival, and overall survival, while exploratory endpoints examine ctDNA clearance and its association with clinical response.
Official title: Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer (SAVED LUNG Study): A Pilot Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
14
Start Date
2025-02
Completion Date
2032-02
Last Updated
2024-12-20
Healthy Volunteers
No
Conditions
Interventions
Observation without surgery
Patients randomized to this arm will forego standard-of-care thoracic surgery and will undergo strict surveillance based on serial radiological follow-up and ctDNA monitoring
Standard-of-care surgery
Patients randomized to this arm will undergo standard-of-care thoracic surgery and undergo post-operative surveillance with serial radiological follow-up and ctDNA monitoring
Locations (1)
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada