Prospective Registrational Trial to Define Real World Outcomes of Patients with Completely Resected Stage I or IIA (tumor \< or = 5cm, node negative) Non-squamous Non-Small Lung Cancer (NSCLC) Identified as High, Intermediate, or Low Risk by a 14-Gene Prognostic Assay DetermaRx being Considered for Adjuvant Platinum-based chemotherapy or other adjuvant therapy versus Observation
This is a prospective, non-randomized, 2 arm, multi-center study in patients with histologically documented non-squamous NSCLC who have undergone complete resection (R0) of the primary tumor with pathologically stage I or IIA disease. Routine paraffin-embedded tumor specimens from completely resected (R0) stage I or IIA patients with non-squamous NSCLC will undergo testing with the DetermaRx 14-Gene Prognostic Assay and will be designated as HIGH, INTERMEDIATE or LOW risk by the assay. The physician and patient will determine the best treatment course and will be assigned to treatment arm based on decision of adjuvant therapy or observation: 1. Adjuvant treatment with a standard NSCLC platin-based doublet, 4 cycle (21-day) regimen of the investigator's choice (Arm 1) or other adjuvant therapy (Arm 1a) which can include combination of chemotherapy and targeted therapy, immunotherapy or other. 2. Observation (Arm 2) All patients will be observed for progression free survival and overall survival to the end of study or death, whichever occurs first. All patients will be observed for disease free survival and overall survival to the end of study or death, whichever occurs first
Study Type
OBSERVATIONAL
Enrollment
55
Adjuvant treatment with a standard NSCLC platin-based doublet, 4 cycle (21-day) regimen of the investigator's choice (Arm 1) or other adjuvant therapy (Arm 1a) which can include combination of chemotherapy and targeted therapy, immunotherapy or other.
All patients will be observed for progression free survival and overall survival to the end of study or death, whichever occurs first.
City of Hope National Medical Center
Duarte, California, United States
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Free Survival (DFS)
To compare Disease Free Survival (DFS) in patients with resected, stage I or IIA non-squamous NSCLC found to be at HIGH/INTERMEDIATE Risk by DetermaRX choosing to undergo adjuvant therapy using a platinum-based doublet or other adjuvant therapy versus observation.
Time frame: 30-36 months
Secondary Objectives
1. To evaluate use patterns of DetermaRx in guiding use of adjuvant platinum-based chemotherapy across early-stage resected lung cancer 2. To evaluate DFS in DetermaRx LOW risk patients who are put on observation alone 3. To evaluate whether use of DetermaRx HIGH/INTERMEDIATE vs. LOW to guide adjuvant platinum-based therapy results in improved OS in patients 4. To evaluate if EGFR mutational status impacts use of adjuvant platinum-based therapy in DetermaRx HIGH/INTERMEDIATE vs. LOW patients
Time frame: 30-36 months
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George Washington Medical Faculty Associates
Washington D.C., District of Columbia, United States
Jupiter Medical Center
Jupiter, Florida, United States
Piedmont Cancer Center
Atlanta, Georgia, United States
Northshore University Healthsystem
Evanston, Illinois, United States
The University of Kansas Hospital
Kansas City, Kansas, United States
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Texas Oncology-San Antonio Medical Center
San Antonio, Texas, United States
...and 8 more locations