Stage II-III Non-small Cell Lung CancerNoSurgeryNCT07131163
Real World Stage II-III NSCLC Patients Receiving Neoadjuvant Chemo-immunotherapy and no Surgical Resection
An observational study of Stage II-III Non-small Cell Lung Cancer, run by Sheba Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stage II-III Non-small Cell Lung Cancer
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- 16 Jul 2024to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stage II-III NSCLC patient who have started neoadjuvant chemo-immunotherapy between January 1st 2022 to September 30th 2024.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Israel1 site, 1 recruiting
- Recruiting
Jusidman Cancer Center, Sheba Medical Center
Ramat Gan, 5262000
Jair Bar, MD-PhD, 972-3530-7097, Jair.Bar@sheba.health.gov.il
About this study
Official title: Neoadjuvant Chemo-immunotherapy Not Resected
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.
Read more
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:
- 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.
Read the detailed description
- Participating centers will secure an ethics and administrative approval 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.
- Where required, patients will be requested to provide informed consent for the participation in the study.
- 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, ii. non-immune-related AEs, iii. molecular test result, iv. re-staging result showing lack of mediastinal clearing, v. distant disease progression, vi. local progression leading to patient becoming not-resectable, vii. re-assessment of patient as not-resectable (without a significant change in the tumor), viii. change in the patient condition making the patient not-operable.
- Data will be entered to an eCRF, anonymized and collected centrally at Sheba MC.
- Analysis of the data according to the statistical analysis plan.
Inclusion criteria:
- 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 mo of follow up after initiation of neoadjuvant treatment.
Statistical analysis plan:
Data will be analyzed based on the reason defined for surgery cancellation. Analyses will be descriptive, reporting mean, median, 95% C.I. as relevant. Time-to-event measures will be estimated by Kaplan-Meier method. Comparisons between groups will be done in a descriptive manner, using t-test, Chi-square and log-rank test as appropriate.
Ethics: Each participating center will receive approval of the local IRB. Unless waived, each participating patient will sign an informed consent form prior to any study procedure.
Patient data confidentiality: No identifying information regarding participating patients will leave each of the centers. Participants will be given a study code, the key connecting the code to the patients' identity will be kept at each participating site secured as per local regulations of each site.
Data transfer: clinical data files (excel or equivalent) will be transferred to Sheba MC by email.
Data sharing: At the end of the study, the clinical data will be made available to requesting researchers following review of requests.
- Conditions
- Stage II-III Non-small Cell Lung Cancer
- Keywords
- neoadjuvant, NSCLC, Non-small-cell lung cancer, immunotherapy, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients that do not undergo surgery after initiating NACT-IO
Percentage of patients who do not reach surgery after initiating NACT-IO
Measured: 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.
Measured: Up to 6 months after initation of NACT-IO
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start16 Jul 2024
- Primary completion28 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II-III Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- Rambam Health Care Campus, Soroka University Medical Center, Gustave Roussy, Cancer Campus, Grand Paris, Hadassah Medical Organization, Rabin Medical Center, University Hospital, Geneva, Tel-Aviv Sourasky Medical Center, MedStar Georgetown University Hospital, Mayo Clinic, UOMi Cancer Center
- Responsible party
- Sponsor
- Investigators
- Jair Bar, MD-PhD, Principal investigator, Jusidman Cancer Center, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131163
- Sponsor's protocol ID
- 2172-25-SMC
- Other IDs
- 8993-11-SMC
- Acronym
- NoSurgery
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Based on direct communication with study officials
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemo-immunotherapy Not Resected
- ClinicalTrials.gov ID
- NCT07131163
- Acronym / sponsor ID
- NoSurgery / 2172-25-SMC
- Conditions
- Stage II-III Non-small Cell Lung Cancer
- Keywords
- neoadjuvant, NSCLC, Non-small-cell lung cancer, immunotherapy, chemotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- Rambam Health Care Campus, Soroka University Medical Center, Gustave Roussy, Cancer Campus, Grand Paris, Hadassah Medical Organization, Rabin Medical Center, University Hospital, Geneva, Tel-Aviv Sourasky Medical Center, MedStar Georgetown University Hospital, Mayo Clinic, UOMi Cancer Center
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- 28 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Detailed description
- Participating centers will secure an ethics and administrative approval 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.
- Where required, patients will be requested to provide informed consent for the participation in the study.
- 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, ii. non-immune-related AEs, iii. molecular test result, iv. re-staging result showing lack of mediastinal clearing, v. distant disease progression, vi. local progression leading to patient becoming not-resectable, vii. re-assessment of patient as not-resectable (without a significant change in the tumor), viii. change in the patient condition making the patient not-operable.
- Data will be entered to an eCRF, anonymized and collected centrally at Sheba MC.
- Analysis of the data according to the statistical analysis plan.
Inclusion criteria:
- 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 mo of follow up after initiation of neoadjuvant treatment.
Statistical analysis plan:
Data will be analyzed based on the reason defined for surgery cancellation. Analyses will be descriptive, reporting mean, median, 95% C.I. as relevant. Time-to-event measures will be estimated by Kaplan-Meier method. Comparisons between groups will be done in a descriptive manner, using t-test, Chi-square and log-rank test as appropriate.
Ethics: Each participating center will receive approval of the local IRB. Unless waived, each participating patient will sign an informed consent form prior to any study procedure.
Patient data confidentiality: No identifying information regarding participating patients will leave each of the centers. Participants will be given a study code, the key connecting the code to the patients' identity will be kept at each participating site secured as per local regulations of each site.
Data transfer: clinical data files (excel or equivalent) will be transferred to Sheba MC by email.
Data sharing: At the end of the study, the clinical data will be made available to requesting researchers following review of requests.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stage II-III NSCLC patient who have started neoadjuvant chemo-immunotherapy between January 1st 2022 to September 30th 2024.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Rate of patients that do not undergo surgery after initiating NACT-IO
Time frame: Up to 6 months after initation of NACT-IO
Percentage of patients who do not reach surgery after initiating NACT-IO
Causes for surgery cancellation
Time frame: Up to 6 months after initation of NACT-IO
Percentage of patients whose surgery is cancelled regarding: Toxicity, disease progression, unresectable, inoperable, other causes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Individual participant dataSharing planned: Yes. Based on direct communication with study officials
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jair Bar, MD-PhD principal investigator
Jusidman Cancer Center, Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stage II-III Non-small Cell Lung Cancer, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jair Bar, MD-PhD (972-3530-7096, Jair.Bar@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients that do not undergo surgery after initiating NACT-IO (time frame: Up to 6 months after initation of NACT-IO). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.