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.
> 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%
NSCLC involving the superior sulcus
Large cell neuro-endocrine cancer (LCNEC)
Sarcomatoid tumor
Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Parallel
Observation without surgery
Other interventionPatients 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
Procedure/SurgeryPatients randomized to this arm will undergo standard-of-care thoracic surgery and undergo post-operative surveillance with serial radiological follow-up and ctDNA monitoring
Safety
Adverse events will be determined as type and grade using the CTCAE v5.0.
Feasibility
Recruitment rate will be defined as the total number of patients recruited (consented) out of the total number of patients approached.
Complete clinical response
Defined by absence of cancer in all of the following evaluations: * Chest CT; * PET/CT scan; * Bronchoscopy; * EBUS; * EUS; * Re-biopsy of lesions that were deemed to be positive for cancer; this includes re-biopsies of all positive lymph nodes and transthoracic needle aspiration of tumors.
Cross-over to surgery
Defined as occurrence of surgery for lung cancer in the observation arm
Event-free survival (EFS) at 12 months
Defined as the proportion of patients remaining event-free at 12 months, from the time of randomization. Patients who are alive without a documented progression will be censored at the time of their last disease evaluation.
Overall survival (OS) at 12 months
Defined as the proportion of patients alive at 12 months, from the time of randomization.
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