Neoadjuvant Chemo-immunotherapy Not Resected

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Stage II-III NSCLC patient, based on clinical staging.

• Treated by a chemo-immunotherapy regimen defined as neoadjuvant treatment, for at least one cycle of treatment.

• No surgery was performed for at least six months from initiation of the neoadjuvant treatment.

• availability of data about reasons for surgery cancellation and clinical follow up.

• patient's consent for data collection (or waiver of the need for consent by the local ethics committee)

• At least 6 month of follow up after intiation of neoadjuvant treatment.

Locations
Other Locations
Israel
Jusidman Cancer Center, Sheba Medical Center
RECRUITING
Ramat Gan
Contact Information
Primary
Jair Bar, MD-PhD
Jair.Bar@sheba.health.gov.il
972-3530-7096
Time Frame
Start Date: 2024-07-16
Estimated Completion Date: 2025-12-30
Participants
Target number of participants: 60
Treatments
NSCLC patients who started neoadjuvant chemo-immontherapy followed by cancellation of surgery
Stage II-III NSCLC patients who started neoadjuvant chemo-immontherapy between January 1st 2022 to September 30th 2024 followed by cancellation of surgery
Sponsors
Collaborators: Mayo Clinic, Tel-Aviv Sourasky Medical Center, Soroka University Medical Center, Rabin Medical Center, University Hospital, Geneva, MedStar Georgetown University Hospital, UOMi Cancer Center, Hadassah Medical Organization, Rambam Health Care Campus, Gustave Roussy, Cancer Campus, Grand Paris
Leads: Sheba Medical Center

This content was sourced from clinicaltrials.gov