Not Yet RecruitingPhase 1

Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer: A Pilot Study

Canada14 participantsStarted 2026-05-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Has no active pregnancy (Refer to "Female participants").
✓. For a woman of child-bearing potential (WOCBP), use of a contraceptive method that is highly effective (with a failure rate of \<1% per year), with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) during the intervention period and for at least 180 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period.
✓. A WOCBP must have a negative highly sensitive pregnancy test (\[urine or serum\] as required by local regulations) within either 24 hours (urine) or 72 hours (serum) before the first dose of study intervention.
✓. If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.

Exclusion criteria

✕. NSCLC involving the superior sulcus
✕. Large cell neuro-endocrine cancer (LCNEC)

What they're measuring

Safety

Timeframe: From randomization through 5 years of follow-up

Feasibility

Timeframe: First two years of the study

Trial details

NCT IDNCT06743555

SponsorCentre hospitalier de l'Université de Montréal (CHUM)

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-02

Contact for this trial

Antoine Desilets, MD, MSc

514-890-8444 antoine.desilets.med@ssss.gouv.qc.ca

View on ClinicalTrials.gov More Non-Small Cell Lung Cancer trials