A Study of Patients Undergoing Neoadjuvant Therapy for Resectable Non-small Cell Lung Cancer to Evaluate Perioperative Circulating Tumor DNA as a Prognostic Biomarker

Overview

About this study

The purpose of this study is to 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

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

Exclusion Criteria:

Patients who do not have a complete preoperative staging evaluation including whole-body PET/CT scan, brain MRI, and mediastinal nodal staging (EBUS or mediastinoscopy).

Eligibility last updated 7/11/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla. Mayo Clinic principal investigator Ian Makey, M.D.	Open for enrollment	Contact information: Mauricia Buchanan R.N. Buchanan.Mauricia@mayo.edu

Mayo Clinic Location

Status

Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Ian Makey, M.D.

Open for enrollment

Contact information:

Mauricia Buchanan R.N.

Buchanan.Mauricia@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials