Evaluating Segmentectomy Surgery After Induction Therapy for Lung Cancer Phase II Single Arm Study to Achieve Complete Tumor Removal with Segmentectomy in Patients Downstaged to Early Lung Cancer

What this Trial Is About

This research investigates the feasibility of performing a high-quality segmentectomy, a type of lung surgery, with complete tumor removal R0 margin status on patients with non-small cell lung cancer NSCLC who were initially diagnosed with advanced-stage disease but have been downstaged to early-stage ycT1cN0M0 after induction therapy. The study aims to explore whether segmentectomy can be safely done without needing to switch to a larger surgery called lobectomy. The trial is motivated by recent evidence showing benefits of segmentectomy in early-stage lung cancer and high downstaging rates after neoadjuvant chemoimmunotherapy in advanced lung cancer patients. Participants will undergo segmentectomy surgery after completing induction therapy, which may include neoadjuvant chemotherapy, immunotherapy, or a combination. The study evaluates the ability to achieve R0 resection using segmentectomy and monitors if conversion to lobectomy is needed. Surgery is scheduled following induction therapy, and the team will track surgical success and safety outcomes within the post-operative period. During the trial, participants will be closely monitored through surgical pathology within 48 hours after surgery to confirm tumor removal status. Safety is assessed by tracking various post-operative outcomes such as length of hospital stay, discharge destination, chest tube removal timing, blood transfusion needs, and any complications or readmissions up to 30 days post-surgery. Lung function tests will be conducted before surgery and at 3 and 6 months afterward to measure respiratory capacity. This study helps understand the surgical options and safety for patients downstaged to early lung cancer after induction therapy.

Segmentectomy After Induction Therapy (SAINT)