RecruitingNCT07131163

Real World Stage II-III NSCLC Patients Receiving Neoadjuvant Chemo-immunotherapy and no Surgical Resection

Neoadjuvant Chemo-immunotherapy Not Resected


Sponsor

Sheba Medical Center

Enrollment

60 participants

Start Date

Jul 16, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

Neoadjuvant chemo-immunotherapy, with or without adjuvant immunotherapy, is currently the standard of care for resectable stage II-III NSCLC. One of the major drawbacks of neoadjuvant treatment is the risk of surgery cancellation. In most of the studies including a neoadjuvant component of treatment, about 20% of recruited patients do not undergo surgery. The reasons for surgery cancellation are recorded as a mixture of adverse events, disease progression, patient's decision and physician's decision. There is lack of data about the precise reasons for cancellation of the surgery. For patients starting neoadjuvant chemo-immunotherapy followed be cancellation of surgery, there is lack of data about the need to add additional treatments and about outcome of these treatments. Depending on the reason for surgery cancellation, these patients might undergo salvage radiotherapy (or chemo-radiotherapy), switch to systemic treatment as for metastatic disease or to palliative care. Goal of the study: to collect real-world data about NSCLC patients that started neoadjuvant chemo-immunotherapy and did not get to surgery. Study conduct Participating centers will secure approvals for retrospective collection of clinical data. Relevant patients will be identified from the working database of each center, data will be collected locally, deidentified and collected centrally at the Sheba MC. Data collected will include: demographics (age, sex); patients' characteristics (smoking status, co-morbidities, ECOG-PS, weight loss); tumor characteristics (histology, molecular tests, specific test results, clinical stage); staging procedures done (CT, PET-CT, brain MRI, EBUS, mediastinoscopy); neoadjuvant treatment (regimen, number of cycles, dose reductions, delays); reason for surgery cancellation; to be categorized according to the following options: iRAE/ non-immune-related AEs/ molecular test results/ re-staging result showing lack of mediastinal clearing/ distant disease progression/ local progression leading to patient becoming not-resectable/ re-assessment of patient as not-resectable (without a significant change in the tumor)/ change in the patient condition making the patient not-operable. Major 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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting real-world data on what happens to patients with stage II or III non-small cell lung cancer (NSCLC) who received chemotherapy combined with immunotherapy before planned surgery, but ultimately did not have their surgery. **You may be eligible if...** - You have stage II or III NSCLC based on clinical staging - You received at least one cycle of a chemo-immunotherapy regimen as neoadjuvant (pre-surgery) treatment - You did not end up having surgery within 6 months of starting that treatment - Information about why surgery was not done is available in your records - You have at least 6 months of follow-up data - You have given consent (or consent has been waived by the ethics committee) **You may NOT be eligible if...** - Surgery was performed within 6 months of starting neoadjuvant treatment - Your data or follow-up records are incomplete Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Jusidman Cancer Center, Sheba Medical Center

Ramat Gan, Israel

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NCT07131163


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