RecruitingSegmentectomy
Segmentectomy After Induction Therapy (SAINT)
Eligible age
18–89 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Northwestern University
You may qualify if…
- ✓ 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.
- ✓ 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.
You may not qualify if…
- ✕ 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
Where it's recruiting
Illinois
Chicago
Source: ClinicalTrials.gov · NCT06496659 · last updated 2026-05-26