Segmentectomy After Induction Therapy (SAINT)

NCT06496659 | Recruiting

• 2 other identifiers: STU00219945NU 23L02
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Segmentectomy

Keywords

Non-Small Cell Lung Cancer; Neoadjuvant therapy; Anatomic resection; Post-induction therapy; Surgical intervention

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 48 hours after date of surgical resection

Secondary Outcomes (11)

• R0 resection rates - on final pathology (post-surgery) if converted to lobectomy

  Up to 48 hours after date of surgical resection

• Ability to complete the intended procedure (sublobar anatomic resection)

  Up to 24 hours after date of surgical resection

• Conversion to lobectomy in a separate operation from sublobar anatomic resection

  Up to 6 weeks after date of surgical resection

• Safety, measured as perioperative outcomes (Post-operative length of stay)

  Up to 30 days after date of surgical resection

• Safety, measured as perioperative outcomes (post-operative discharge destination)

  Up to 30 days after date of surgical resection

Study Arms (1)

Segmentectomy after Induction Therapy

OTHER

Surgical intervention (segmentectomy) post induction therapy for Non-Small Cell Lung Cancer

Procedure: Segmentectomy

Interventions

Segmentectomy PROCEDURE

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.

Segmentectomy after Induction Therapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.
• 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

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
• 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.

Sponsors & Collaborators

• Northwestern University: lead
• Robert H. Lurie Comprehensive Cancer Center of Northwestern University: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Officials

• Ankit Bharat, M.D.

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ankit Bharat, M.D.

CONTACT

312-926-7628; Ankit.Bharat@northwestern.edu

Nisha Palanisamy

CONTACT

312-926-7577; nisha.palanisamy@nm.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Thoracic Surgery

Study Record Dates

• First Submitted: May 14, 2024
• First Posted: July 11, 2024
• Study Start: August 2, 2024
• Primary Completion (Estimated): July 30, 2029
• Study Completion (Estimated): July 30, 2029
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)