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

NCT07131163 | Recruiting

• 2 other identifiers: 2172-25-SMC8993-11-SMC
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 1.Stage II-III NSCLC patient, based on clinical staging.
2. 2.Treated by a chemo-immunotherapy regimen defined as neoadjuvant treatment, for at least one cycle of treatment.
3. 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

Keywords

neoadjuvant; NSCLC; Non-small-cell lung cancer; immunotherapy; chemotherapy

Outcome Measures

Primary Outcomes (2)

• Rate of patients that do not undergo surgery after initiating NACT-IO

  Percentage of patients who do not reach surgery after initiating NACT-IO

  Up to 6 months after initation of NACT-IO

• Causes for surgery cancellation

  Percentage of patients whose surgery is cancelled regarding: Toxicity, disease progression, unresectable, inoperable, other causes.

  Up to 6 months after initation of NACT-IO

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage II-III NSCLC patient who have started neoadjuvant chemo-immunotherapy between January 1st 2022 to September 30th 2024.

You may qualify if:

• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead
• Rambam Health Care Campus: collaborator
• Soroka University Medical Center: collaborator
• Gustave Roussy, Cancer Campus, Grand Paris: collaborator
• Hadassah Medical Organization: collaborator
• Rabin Medical Center: collaborator
• University Hospital, Geneva: collaborator
• Tel-Aviv Sourasky Medical Center: collaborator
• MedStar Georgetown University Hospital: collaborator
• Mayo Clinic: collaborator
• UOMi Cancer Center: collaborator

Study Sites (1)

Jusidman Cancer Center, Sheba Medical Center

Ramat Gan, 5262000, Israel

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jair Bar, MD-PhD

  Jusidman Cancer Center, Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jair Bar, MD-PhD

CONTACT

972-3530-7096; Jair.Bar@sheba.health.gov.il

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: August 20, 2025
• Study Start: July 16, 2024
• Primary Completion: December 28, 2025
• Study Completion: December 30, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Starting from study publication for 2 years.
• Access Criteria: Based on direct communication with study officials

Locations

IL (1)