Study To Evaluate Tumor DNA in Patients Undergoing Therapy For Lung Cancer (H-47159)

Study To Evaluate Perioperative Circulating Tumor DNA As A Prognostic Biomarker In Patients Undergoing Neoadjuvant Therapy For Resectable Non-Small Cell Lung Cancer

Objectives:

• Aim 1: Determine the validity of employing quantitative ctDNA as a surrogate marker for pathologic treatment response in patients receiving neoadjuvant therapy for Stage IIA-IIIB NSCLC undergoing curative-intent resection. We will assess the relationship between major pathologic response (≤10% viable tumor remaining) and percent change in levels of ctDNA concentration before and after neoadjuvant therapy.
• Aim 2: Determine the prognostic value of persistent ctDNA in patients with NSCLC undergoing curative-intent resection in predicting recurrence, disease-free and overall survival. More specifically, we will assess the relationship between ctDNA levels over time and the time-to-event endpoints of recurrence, disease-free and overall survival. We will monitor levels of ctDNA measured in Aim 1 over the course of neoadjuvant treatment as well as throughout postoperative surveillance, and correlate these levels with recurrence, disease-free and overall survival.
• Aim 3: Correlate the percent change in levels of ctDNA to percent change in the SUVmax of the primary tumor on 18-FDG-PET scan pre- and post-neoadjuvant therapy.

Design:

Patients 18 years of age or older deemed surgically resectable and medically operable by a qualified thoracic surgeon with clinical stage IIA IIIB NSCLC being treated with neoadjuvant cytotoxic, targeted or immunothe rapy with or without radiotherapy are eligible. A complete preoperative staging evaluation must be completed according to the National Comprehensive Cancer Network guidelines including whole-body PET/CT scan, brain MRI, and mediastinal nodal staging (EBUS or mediastinoscopy) to be eligible for analysis.

Eligibility:

Patients 18 years of age or older deemed surgically resectable and medically operable by a qualified thoracic surgeon with clinical stage IIA IIIB NSCLC being treated with neoadjuvant cytotoxic, targeted or immunotherapy with or without radiotherapy are eligible.