A Phase 1 interventional study of Observation without surgery and Standard-of-care surgery in Non-Small Cell Lung Cancer, Immunotherapy and Neoadjuvant Therapy, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-14.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Phase 1, Interventional, and Treatment
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.
After neoadjuvant therapy, all participants undergo intensified re-staging invasive and non-invasive modalities to assess for complete clinical response:
Participants with complete clinical response defined by absence of disease as measured by all the above modalities will be randomized 1:1 to either observation or surgery.
Only patients with complete clinical response will proceed to the randomization stage of the trial. Block randomization will occur 1:1 with two participants per block. All other patients will remain on study and undergo therapy as per standard-of-care and will have follow-up on study. Both groups will have blood collected for ctDNA at this stage. For participants in the surgery arm, the blood sample will be 3 weeks after surgery, while participants in surveillance only arm will have the blood sample 3 weeks after randomization.
For female participants:
Exclusion Criteria:
Has one of the following tumor locations/types:
Participants undergo surgery followed by the same surveillance schedule as Arm A. ctDNA testing is conducted 3 weeks post-surgery and again at 6 months. Surveillance includes low-dose CT scans, physical examinations, and ECOG assessments every 3 months for 12 months, with long-term monitoring at regular intervals up to 5 years.
Procedure: Standard-of-care surgery
Participants undergo surveillance without surgery, including a low-dose CT scan of the thorax and upper abdomen, ECOG assessment, and physical examination every 3 months for the first 12 months. Additional ctDNA testing is performed 3 weeks post-randomization and at 6 months. Long-term follow-up includes similar assessments every 6-12 months up to 5 years.
Other: 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
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
Safety
Adverse events will be determined as type and grade using the CTCAE v5.0.
Time frame: From randomization through 5 years of follow-up
Feasibility
Recruitment rate will be defined as the total number of patients recruited (consented) out of the total number of patients approached.
Time frame: First two years of the study
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.
Time frame: Restaging 3 weeks after completion of neoadjuvant therapy (3 cycles of nivolumab and platinum-doublet chemotherapy)
Cross-over to surgery
Defined as occurrence of surgery for lung cancer in the observation arm
Time frame: From randomization through 5 years of follow-up
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.
Time frame: 12 months following randomization
Overall survival (OS) at 12 months
Defined as the proportion of patients alive at 12 months, from the time of randomization.
Time frame: 12 months following randomization
Circulation tumor DNA (ctDNA) clearance
Defined as presurgery change from detectable levels of ctDNA before cycle 1 to undetectable ctDNA before surgery.
Time frame: 3 weeks post-randomization (surveillance arm) or 3 weeks post-surgery (standard-of-care surgery arm)
Plan to share: No
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
Centre hospitalier de l'Université de Montréal (CHUM)