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New treatment option for Segmentectomy
Official title Segmentectomy After Induction Therapy (SAINT)
ClinicalTrials.gov ID: NCT06496659
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 89
You may be able to join if
- Patients must have histologically confirmed non-small-cell lung cancer that is clinically staged as ≤ycT1cN0M0 (tumor size 3cm or less on greatest...
- 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.
You likely can't join 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...
- 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...
- Patients that do not have documented consensus agreement on the feasibility of anatomic sublobar resection (segmentectomy) from at least 2 study...
- Patients with pre-induction therapy tumor involving greater than 1 lobe.
See the full eligibility criteria
Who can 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...
- 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...
- 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...
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for...
- 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...
- 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...
- 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)
What rules you out
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.