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NCT06743555
Surgery After Verifying Existing Disease in Locally Advanced Operable Lung Cancer: A Pilot Study
Conditions: Non-Small Cell Lung Cancer, Immunotherapy, Neoadjuvant Therapy, Thoracic Surgery, Complete Response
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1
Enrollment: 14
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Location: Centre hospitalier de l'Université de Montréal (CHUM) Montreal Quebec
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.
Eligibility Criteria
Inclusion Criteria:
* \> 18 years of age
* The participant has provided documented informed consent for the trial.
* Histologically confirmed (by core biopsy) NSCLC and confirmed clinical stages II-III (excluding N2) NSCLC (AJCC 8th edition) amenable to receive neoadjuvant chemo-immunotherapy defined by: nivolumab 3mg/kg Q3W in combination with platinum doublet chemotherapy (cisplatin or carboplatin with paclitaxel or pemetrexed Q3W) for 3 cycles.
* PD-L1 tumor proportion score \>50%
* Has no history of immunodeficiency, HBV, HCV, HIV.
* For female participants:
1. Has no active pregnancy (Refer to "Female participants").
2. For a woman of child-bearing potential (WOCBP), use of a contraceptive method that is highly effective (with a failure rate of \
Source: ClinicalTrials.gov (NCT06743555). StuddyBuddy aggregates publicly available trial information.
