NCT07131163: NoSurgery

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

Recruiting now Last updated 20 August 2025

What this trial tests

trial in Stage II-III Non-small Cell Lung Cancer in 60 participants. Currently enrolling.

Timeline

16 July 2024

Primary endpoint
28 December 2025

30 December 2025

Quick facts

Lead sponsor	Sheba Medical Center
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	60
Start date	16 July 2024
Primary completion	28 December 2025
Estimated completion	30 December 2025
Sites	1 location across Israel

Conditions studied

• Stage II-III Non-small Cell Lung Cancer — all drugs for Stage II-III Non-small Cell Lung Cancer →

Sponsor

Sheba Medical Center

Who can join

18 and older, any sex, with Stage II-III Non-small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.