Stage II-III NSCLC patients who start neoadjuvant chemo-immunotherapy but do not undergo planned surgery
Official title: Neoadjuvant Chemo-immunotherapy Not Resected
Run by Sheba Medical Center · NCT07131163 · Data updated 2026-11-12
This project will see what happens to people with stage II-III non-small cell lung cancer who begin neoadjuvant chemo-immunotherapy but end up not having the planned surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Sheba Medical Center Government |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Ramat Gan) |
| Status | Recruiting |
| Started | July 16, 2024 |
| Main results expected | December 28, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | August 20, 2025 |
| Trial ID | NCT07131163 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with clinically staged II–III NSCLC who received at least one cycle of neoadjuvant chemo-immunotherapy, have documentation of the reason for surgery cancellation, and at least six months of follow-up.
✕Probably not a fit
Patients who underwent planned surgery, who were treated outside the participating centers, who lack documentation about cancellation reasons, or who have less than six months of follow-up are unlikely to benefit from this analysis.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter retrospective registry will collect de-identified clinical data on patients with clinically staged II–III NSCLC who received at least one cycle of neoadjuvant chemo-immunotherapy and did not undergo surgery within six months. Participating centers will extract demographics, tumor and staging characteristics, treatment details, reasons for surgery cancellation (categorized as immune-related AEs, non-immune AEs, progression, re-assessment, molecular findings, or change in operability), and subsequent therapies. Data will be entered into a centralized eCRF at Sheba Medical Center and analyzed according to a predefined statistical analysis plan. The aim is to describe cancellation reasons, downstream management (salvage radiotherapy, systemic therapy, palliative care), and patient outcomes.
Why it matters
Potential benefit: If successful, this work could help clinicians choose the best follow-up treatments and improve outcomes for patients whose surgery is cancelled after neoadjuvant therapy.
How similar studies have gone: Prior neoadjuvant trials have reported about 20% surgery cancellation, but detailed multicenter data on exact cancellation reasons and subsequent management and outcomes remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Stage II-III NSCLC patient, based on clinical staging. 2. Treated by a chemo-immunotherapy regimen defined as neoadjuvant treatment, for at least one cycle of treatment. 3. No surgery was performed for at least six months from initiation of the neoadjuvant treatment. 4. availability of data about reasons for surgery cancellation and clinical follow up. 5. patient's consent for data collection (or waiver of the need for consent by the local ethics committee) 6. At least 6 month of follow up after intiation of neoadjuvant treatment.
Where it's running
-
Jusidman Cancer Center, Sheba Medical Center
Ramat Gan, Israel Recruiting
Study contacts
- Principal investigator: Jair Bar, MD-PhD — Jusidman Cancer Center, Sheba Medical Center
- Study coordinator: Jair Bar, MD-PhD
- Email: Jair.Bar@sheba.health.gov.il
- Phone: 972-3530-7096
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.