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

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.

Conditions

• Stage II-III Non-small Cell Lung Cancer

Sponsors & Collaborators

• Rambam Health Care Campus

  collaborator OTHER

• Soroka University Medical Center

  collaborator OTHER

• Gustave Roussy, Cancer Campus, Grand Paris

  collaborator OTHER

• Hadassah Medical Organization

  collaborator OTHER

• Rabin Medical Center

  collaborator OTHER

• University Hospital, Geneva

  collaborator OTHER

• Tel-Aviv Sourasky Medical Center

  collaborator OTHER_GOV

• MedStar Georgetown University Hospital

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• UOMi Cancer Center

  collaborator OTHER

• Sheba Medical Center

  lead OTHER_GOV

Principal Investigators

• Jair Bar, MD-PhD · Jusidman Cancer Center, Sheba Medical Center

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-07-16

Primary Completion

2025-12-28

Completion

2025-12-30

Countries

• Israel

Study Locations