Segmentectomy After Induction Therapy (SAINT) for Lung Cancer

This study, called SAINT, is looking at a surgical procedure called a segmentectomy. A segmentectomy removes a part of your lung. This surgery is for people with non-small cell lung cancer (NSCLC) who have already received initial treatment (induction therapy) and whose cancer has shrunk to a smaller stage (T1cN0M0, meaning the tumor is 3cm or less, with no spread to lymph nodes or other parts of the body). Researchers want to see if segmentectomy can be successfully performed in these patients, removing all cancer with clear margins. This study is currently unclear on its status and plans to enroll 25 participants.

Study design: This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 25 participants.
What's involved: Participants will undergo a segmentectomy, a surgical procedure to remove a segment of the lung.
Compensation: Not stated in the trial record.
Follow-up: The primary outcome, successful segmentectomy with clear margins, is measured up to 48 hours after surgery.

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Segmentectomy After Induction Therapy (SAINT)

Recruiting

NAAges 18–89InterventionalTreatment

Northwestern University

~25 participants

Updated 2026-05-26 on ClinicalTrials.gov

What's tested:Segmentectomy

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of participants with Segmentectomy and R0 on final pathology

Measured over Up to 48 hours after date of surgical resection

Conditions

Segmentectomy

Where it's being run

1 sites across 1 states

Illinois1

Study leadership

Ankit Bharat, M.D. · PRINCIPAL_INVESTIGATOR · Northwestern University

Who to contact

Ankit Bharat, M.D.

[email protected]

312-926-7628

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Eligibility criteria

Inclusion

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.

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.

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)

Exclusion

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.

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.

What this trial measures

Number of participants with Segmentectomy and R0 on final pathologyUp 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.

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