Stage II-III NSCLC patients who start neoadjuvant chemo-immunotherapy but do not undergo planned surgery

Neoadjuvant Chemo-immunotherapy Not Resected

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
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sheba Medical Center (other gov)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Ramat Gan)
• Trial ID: NCT07131163 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Prior neoadjuvant trials have reported about 20% surgery cancellation, but detailed multicenter data on exact cancellation reasons and subsequent management and outcomes remain limited.

Eligibility 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 this trial is running

Ramat Gan

• 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

Conditions: Stage II-III Non-small Cell Lung Cancer, neoadjuvant, NSCLC, Non-small-cell lung cancer, immunotherapy, chemotherapy