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.
• 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
• Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \> 12 months)