SegmentectomySAINTNCT06496659
Segmentectomy After Induction Therapy (SAINT)
A study testing Segmentectomy in people with Segmentectomy, run by Northwestern University at 1 site in United States.
Trial summary
The primary objective will be to determine the feasibility of performing a high-quality sublobar anatomic resection (segmentectomy) with R0 margin status on final pathology for patients who received induction therapy for NSCLC and are downstaged to ≤ycT1cN0M0 (TDi 3cm or less). Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Segmentectomy
- What is being tested?
- Segmentectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2024to 30 Jul 2029
- Phase
- Interventional
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have histologically confirmed non-small-cell lung cancer that is clinically staged as ≤ycT1cN0M0 (tumor size 3cm or less on greatest dimension measured by cross-sectional imaging) after receiving induction therapy.
- Patients may have received any regimen of neoadjuvant chemotherapy, neoadjuvant immunotherapy, or neoadjuvant chemoimmunotherapy.
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
- Patients must be age ≥ 18 years.
- Patients must exhibit a/an ECOG (Eastern Cooperative Oncology Group) performance status of <3.
- Patients must have adequate organ function as defined below: These are guidelines that may or should be modified based on protocol-specific or drug development-specific needs.
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- Table 1: Measures of Adequate Organ Function. FEV1 or DLCO ≥40% (DLCO: diffusing capacity of lung for carbon monoxide)
- For patients with a known history of Human immunodeficiency virus (HIV), infected patients on effective anti-retroviral therapy must have a viral load undetectable for 6 months prior to registration.
- For patients with a known history of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- Patients with a known history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be considered a candidate for surgical resection under general anesthesia.
- Females of child-bearing potential (FOCBP) must have a negative pregnancy test prior to registration on study.
- NOTE: A FOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy
- Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for > 12 months)
Who cannot join
- Patients who have had prior lung resection or thoracic surgery.
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
- Patients who are receiving any other investigational agents.
- Patients with evidence of distant metastases including brain metastases will be excluded from this study because they will not benefit from surgical resection.
- Patients that do not have documented consensus agreement on the feasibility of anatomic sublobar resection (segmentectomy) from at least 2 study surgeons will not be enrolled.
- Patients with pre-induction therapy tumor involving greater than 1 lobe.
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- Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following, are not eligible:
- Hypertension that is not controlled on medication
- Ongoing or active infection requiring systemic treatment
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness/social situations that would limit compliance with study requirements
- Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints
- Female patients who are pregnant. Pregnant patients are excluded from this study because the study protocol requires frequent cross-sectional imaging with potential for teratogenic effects.
- Patients with another malignancy within 3 years (except for non-melanoma skin cancer, CIS of cervix (a preinvasive carcinomatous change of the cervix), superficial bladder cancer). Patients with prior malignancies are excluded to isolate overall survival outcomes.
- Patients with active smoking status or cessation <4 weeks prior to surgical resection.
- Patients with biopsy positive hilar or mediastinal lymph nodes following induction therapy detected by EBUS (endobronchial ultrasound), mediastinoscopy, or intraoperative sampling.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Ankit Bharat, M.D., 312-926-7628, Ankit.Bharat@northwestern.edu
Nisha Palanisamy, 312-926-7577, nisha.palanisamy@nm.org
About this study
Official title: Segmentectomy After Induction Therapy (SAINT): Phase II Single Arm Trial Evaluating Segmentectomy in Accomplishing R0 Resection for Patients With Lung Cancer Treated With Neoadjuvant Therapy
The primary objective will be to determine the feasibility of performing a high-quality sublobar anatomic resection (segmentectomy) with R0 margin status on final pathology for patients who received induction therapy for NSCLC and are downstaged to ≤ycT1cN0M0 (TDi 3cm or less). T1c is tumor staging 1 and c stands for tumor is considered larger than 2cm but no larger than 3cm across; N0 is No regional lymph node metastasis; M0 is No distant metastasis.
Read the detailed description
With the advent of effective neoadjuvant therapies, many patients with Stage II or III lung cancer are being downstaged to Stage I. Recent studies have shown that sublobar resections, especially segmentectomy, offer superior long-term survival and quality of life for patients with Stage I cancer. However, aside from isolated cases, the safety and feasibility of performing segmentectomy on patients who were initially diagnosed with advanced-stage cancer but were later downstaged to Stage I remain unexplored. Thus, our hypothesis is that segmentectomy can be safely executed in these downstaged Stage I patients after neoadjuvant therapy, without necessitating a conversion to lobectomy due to technical complications. Both segmentectomy and lobectomy are considered standard-of-care lung resection procedures.
Recent randomized clinical trials have demonstrated high rates of pathological downstaging for locally advanced lung cancer treated with neoadjuvant chemoimmunotherapy with R0 resection rates of 83.2% to 77.8% in recent historical controls. Other recent trials demonstrated that high-quality segmentectomy is associated with improved overall survival and is now standard-of-care for early-stage lung cancer with small tumor sizes. Given these findings, the logical next step is to determine if the benefits of high-quality segmentectomy may be extended to an increasingly common clinical scenario where locally advanced lung cancers are downstaged to small tumor size after induction therapy.
- Conditions
- Segmentectomy
- Being tested
- Segmentectomy
- Keywords
- Non-Small Cell Lung Cancer, Neoadjuvant therapy, Anatomic resection, Post-induction therapy, Surgical intervention
- 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.
SegmentectomyProcedure or surgery
A segmentectomy is a surgical procedure to remove a segment of the lung. This surgery will be done on patients who have completed neoadjuvant therapy for diagnosis of Non-Small Cell Lung Cancer.
| Study group | Role | What they receive |
|---|---|---|
| Segmentectomy after Induction Therapy | Other | Surgical intervention (segmentectomy) post induction therapy for Non-Small Cell Lung Cancer Receives: Procedure: Segmentectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Segmentectomy and R0 on final pathology
The primary objective will be to determine the feasibility of performing a high-quality sublobar anatomic resection (segmentectomy) with R0 margin status on final pathology for patients who received induction therapy for NSCLC and are downstaged to ≤ycT1cN0M0 (TDi 3cm or less).
To address the primary objective, the proportion of patients who receive high-quality segmentectomy will be determined immediately at the end of the operation and R0 rates on final pathology will be collected after the surgical operation when pathological reports are completed.
Measured: Up to 48 hours after date of surgical resection
Secondary outcomes (11)
R0 resection rates - on final pathology (post-surgery) if converted to lobectomy
The proportion of patients who received lobectomy with R0 resection on final pathology (post-surgery).
Measured: Up to 48 hours after date of surgical resection
Ability to complete the intended procedure (sublobar anatomic resection)
The proportion of patients with completion of the intended procedure (sublobar anatomic resection) based on the extent of surgical resection immediately at the end of the operation
Measured: Up to 24 hours after date of surgical resection
Conversion to lobectomy in a separate operation from sublobar anatomic resection
The proportion of patients who were converted to lobectomy during the operation or within six weeks after the operation for patients who undergo revision.
Measured: Up to 6 weeks after date of surgical resection
Safety, measured as perioperative outcomes (Post-operative length of stay)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (post-operative length-of-stay):
- Post-operative length of stay defined from the date of surgery until hospital discharge.
-Outcome measured in number of days
Measured: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (post-operative discharge destination)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (post-operative discharge destination)
- Post-operative discharge destination defined as including: i. Home ii. Extended Care/ Transitional Care Unit/ Rehab iii. Other Hospital iv. Nursing Home v. Hospice vi. Other vii. Expired
Measured: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (time to chest tube removal)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (time to chest tube removal)
-Outcome measured as number of days from date of surgical resection to time of chest tube removal
Measured: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (blood transfusion requirements)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (blood transfusion requirements)
-Outcome measured as number of units blood transfused, if required
Measured: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (30-day unplanned readmission)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (30-day unplanned readmission)
-Outcome measured as number of days if unplanned readmission required after date of discharge following surgical resection and reasoning for readmission
Measured: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (30-day morbidity)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (30-day morbidity)
-Outcome measured as status of participant at 30 days post-discharge from surgical resection procedure (alive or deceased)
Measured: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (30-day mortality)
Safety, measured as perioperative outcomes for patients who receive lobectomy or sublobar anatomic resection (30-day mortality)
-Outcome measured as date of death within 30 days following discharge from surgical resection procedure
Measured: Up to 30 days after date of surgical resection
Change in pre-operative FEV1 (forced expiratory volume at one second) at 3 and 6 months for lobectomy and sublobar anatomic resection
Changes in FEV1 pulmonary function from baseline to 3 and 6 months following lung resection for patients who receive sublobar anatomic resection or are converted to lobectomy.
FEV1 will be measured using pulmonary function tests and expressed as % of expected value. Changes in FEV1 measured at baseline and at 3 and 6 months post-surgery
Measured: Prior to surgical resection (baseline) and after surgical resection (3 months and 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2024
- Study start2 Aug 2024
- Primary completion30 Jul 2029 (estimated)
- Study completion30 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SegmentectomyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University
- Responsible party
- Principal investigator, Ankit Bharat, Northwestern University
- Investigators
- Ankit Bharat, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06496659
- Sponsor's protocol ID
- STU00219945
- Other IDs
- NU 23L02
- Acronym
- SAINT
- Status last verified
- May 2026
- First submitted
- 14 May 2024
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmentectomy After Induction Therapy (SAINT): Phase II Single Arm Trial Evaluating Segmentectomy in Accomplishing R0 Resection for Patients With Lung Cancer Treated With Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT06496659
- Acronym / sponsor ID
- SAINT / STU00219945
- Conditions
- Segmentectomy
- Keywords
- Non-Small Cell Lung Cancer, Neoadjuvant therapy, Anatomic resection, Post-induction therapy, Surgical intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Robert H. Lurie Comprehensive Cancer Center of Northwestern University
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 30 Jul 2029 (estimated)
- Study completion
- 30 Jul 2029 (estimated)
- First posted
- 11 Jul 2024 (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.
The primary objective will be to determine the feasibility of performing a high-quality sublobar anatomic resection (segmentectomy) with R0 margin status on final pathology for patients who received induction therapy for NSCLC and are downstaged to ≤ycT1cN0M0 (TDi 3cm or less). T1c is tumor staging 1 and c stands for tumor is considered larger than 2cm but no larger than 3cm across; N0 is No regional lymph node metastasis; M0 is No distant metastasis.
Detailed description
With the advent of effective neoadjuvant therapies, many patients with Stage II or III lung cancer are being downstaged to Stage I. Recent studies have shown that sublobar resections, especially segmentectomy, offer superior long-term survival and quality of life for patients with Stage I cancer. However, aside from isolated cases, the safety and feasibility of performing segmentectomy on patients who were initially diagnosed with advanced-stage cancer but were later downstaged to Stage I remain unexplored. Thus, our hypothesis is that segmentectomy can be safely executed in these downstaged Stage I patients after neoadjuvant therapy, without necessitating a conversion to lobectomy due to technical complications. Both segmentectomy and lobectomy are considered standard-of-care lung resection procedures.
Recent randomized clinical trials have demonstrated high rates of pathological downstaging for locally advanced lung cancer treated with neoadjuvant chemoimmunotherapy with R0 resection rates of 83.2% to 77.8% in recent historical controls. Other recent trials demonstrated that high-quality segmentectomy is associated with improved overall survival and is now standard-of-care for early-stage lung cancer with small tumor sizes. Given these findings, the logical next step is to determine if the benefits of high-quality segmentectomy may be extended to an increasingly common clinical scenario where locally advanced lung cancers are downstaged to small tumor size after induction therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Segmentectomy after Induction Therapy | Other | Procedure: SegmentectomySurgical intervention (segmentectomy) post induction therapy for Non-Small Cell Lung Cancer |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients must have histologically confirmed non-small-cell lung cancer that is clinically staged as ≤ycT1cN0M0 (tumor size 3cm or less on greatest dimension measured by cross-sectional imaging) after receiving induction therapy.
- Patients may have received any regimen of neoadjuvant chemotherapy, neoadjuvant immunotherapy, or neoadjuvant chemoimmunotherapy.
- Patients must have the ability to understand and the willingness to sign a written informed consent document.
- Patients must be age ≥ 18 years.
- Patients must exhibit a/an ECOG (Eastern Cooperative Oncology Group) performance status of <3.
Key exclusion criteria (18 listed)
- Patients who have had prior lung resection or thoracic surgery.
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > Grade 1) with the exception of alopecia.
- Patients who are receiving any other investigational agents.
- Patients with evidence of distant metastases including brain metastases will be excluded from this study because they will not benefit from surgical resection.
- Patients that do not have documented consensus agreement on the feasibility of anatomic sublobar resection (segmentectomy) from at least 2 study surgeons will not be enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SegmentectomyA segmentectomy is a surgical procedure to remove a segment of the lung. This surgery will be done on patients who have completed neoadjuvant therapy for diagnosis of Non-Small Cell Lung Cancer. | Procedure or surgery | Segmentectomy after Induction Therapy |
Primary outcome
Number of participants with Segmentectomy and R0 on final pathology
Time frame: Up to 48 hours after date of surgical resection
The primary objective will be to determine the feasibility of performing a high-quality sublobar anatomic resection (segmentectomy) with R0 margin status on final pathology for patients who received induction therapy for NSCLC and are downstaged to ≤ycT1cN0M0 (TDi 3cm or less). To address the primary objective, the proportion of patients who receive high-quality segmentectomy will be determined immediately at the end of the operation and R0 rates on final pathology will be collected after the surgical operation when pathological reports are completed.
11 secondary outcomes
R0 resection rates - on final pathology (post-surgery) if converted to lobectomy
Time frame: Up to 48 hours after date of surgical resection
Ability to complete the intended procedure (sublobar anatomic resection)
Time frame: Up to 24 hours after date of surgical resection
Conversion to lobectomy in a separate operation from sublobar anatomic resection
Time frame: Up to 6 weeks after date of surgical resection
Safety, measured as perioperative outcomes (Post-operative length of stay)
Time frame: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (post-operative discharge destination)
Time frame: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (time to chest tube removal)
Time frame: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (blood transfusion requirements)
Time frame: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (30-day unplanned readmission)
Time frame: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (30-day morbidity)
Time frame: Up to 30 days after date of surgical resection
Safety, measured as perioperative outcomes (30-day mortality)
Time frame: Up to 30 days after date of surgical resection
Change in pre-operative FEV1 (forced expiratory volume at one second) at 3 and 6 months for lobectomy and sublobar anatomic resection
Time frame: Prior to surgical resection (baseline) and after surgical resection (3 months and 6 months)
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 26 May 2026.
- Individual participant dataSharing planned: No
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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.
Ankit Bharat, M.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Segmentectomy in people with Segmentectomy, run by Northwestern University at 1 site in United States.
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 16 inclusion and 18 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 26 May 2026. 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 United States. 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 Ankit Bharat, M.D. (312-926-7628, Ankit.Bharat@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Segmentectomy and R0 on final pathology (time frame: Up to 48 hours after date of surgical resection). 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 26 May 2026.