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Neoadjuvant Therapy / Standard-of-care surgery / Observation without surgery · Phase 1 Trial
ClinicalTrials.gov · August 14, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for a Phase 1 pilot randomized trial comparing observation versus standard surgery in patients with stage II–III NSCLC who achieved complete clinical response after neoadjuvant chemotherapy and immunotherapy. No results are yet posted; the study is in pre-recruitment and is designed to evaluate safety and feasibility in a very small, highly selected population (PD-L1 ≥50%, complete response post-neoadjuvant therapy).
Phase 1, Interventional, Randomized, Parallel, Open label, Treatment purpose. Non-Small Cell Lung Cancer, Immunotherapy, Neoadjuvant Therapy, Thoracic Surgery, Complete Response; age from 18 Years. Intervention: Observation without surgery. Compared with: Standard-of-care surgery — Active Comparator. n = 14. 1 site: Canada.
Primary outcomes: Safety and feasibility assessed from randomization through 5 years of follow-up Planned enrollment: 14 participants with stage II–III NSCLC and PD-L1 ≥50% achieving complete clinical response after neoadjuvant platinum-doublet chemotherapy plus immunotherapy Randomization to observation versus standard-of-care surgery after rigorous restaging
No efficacy or safety data, effect sizes, or comparative outcomes are reported in this registry record. Primary outcomes: Safety and feasibility assessed from randomization through 5 years of follow-up
This registry record describes a planned trial; no clinical guidance can be drawn until results are published. The highly selective population (complete responders with high PD-L1) may limit generalizability to routine NSCLC practice, and the small pilot size means any findings will require confirmation before changing clinical care.
This is a Phase 1 pilot trial registration with no results reported; it is designed to assess safety and feasibility in a small, highly selected population and cannot yet support clinical recommendations.
As stated by the source record.
Quoted from the source exactly as published.
This registry record describes a planned trial; no clinical guidance can be drawn until results are published. The highly selective population (complete responders with high PD-L1) may limit generalizability to routine NSCLC practice, and the small pilot size means any findings will require confirmation before changing clinical care.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT06743555). This is a study registration, not published results. Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM). Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 14 participants (ESTIMATED). Conditions: Non-Small Cell Lung Cancer, Immunotherapy, Neoadjuvant Therapy, Thoracic Surgery, Complete Response. Interventions: OTHER: Observation without surgery; PROCEDURE: Standard-of-care surgery. Primary outcome measures: Safety , From randomization through 5 years of follow-up; Feasibility , First two years of the study. Brief 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.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.