This longitudinal study looks to quantify the testing timeline, operational barriers, and outcomes of biomarker-guided therapy in a large, community-based, and largely unselected patient population with early stage and advanced stage, treatment-naive non-small cell lung cancer, whether squamous or non-squamous.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Adult subjects (18 years and older) with newly diagnosed early stage, locally advanced or metastatic non-small cell lung cancer
* Must be eligible for systemic therapy based on the treating provider's assessment. If systemic therapy was recommended and documented by the treating provider but the patient declined, they can still be eligible for the study. Patients can be enrolled prior to start of treatment.
* Subjects who developed locally advanced or metastatic disease after receiving adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of locally advanced or metastatic disease
* Subjects must be enrolled within 30 days of initiation of systemic therapy
* Signed informed consent
Exclusion Criteria:
* Stage IA at the time of enrollment
* Subjects with small cell lung cancer
* Subjects with Unknown primary tumor origin
Primary outcome measure(s)
Proportion of Patients Who Receive Biomarker Test Results Prior to Systemic Therapy or Death — 5 years from date of enrollment into study
Proportion of Patients Who Receive Single-gene Testing Compared to Those that Receive Comprehensive Biomarker Testing — 5 years from date of enrollment into study Comprehensive biomarker testing is defined as both PD-L1 testing to guide the use of immunotherapies and testing for all genomic alterations for which there are FDA-approved therapies including (but not limited to) EGFR, ALK, ROS1, BRAF, NTRK, RET, KRAS and MET.
For Patients without Biomarker Test Results, List Reasons for Not Conducting Testing — 5 years from date of enrollment into study 1. Clinical deterioration, clinical crisis
2. Tissue: obtaining sample, tissue retrieval
3. Assay failure for 1 or more biomarkers: Quantity Not Sufficient (QNS), Quality Assurance (QA) fail, test failure
4. Patient/provider attitudes \& perceptions
5. Provider knowledge about testing options
6. Patient knowledge about biomarker testing
7. Payor Coverage: prior authorization denial, payor refusal
8. Financial barriers: uncovered costs, reimbursement
Trial sites (17)
Facility
City
Region
Status
Southern Cancer Center, PC
Daphne
Alabama
Recruiting
Arizona Oncology Associates, PC - NAHOA
Prescott Valley
Arizona
Not Yet Recruiting
Rocky Mountain Cancer Center
Denver
Colorado
Active Not Recruiting
Cancer Care Centers of Brevard, Inc.
Palm Bay
Florida
Recruiting
Woodlands Medical Specialists, PA
Pensacola
Florida
Active Not Recruiting
Affiliated Oncologists, LLC
Chicago Ridge
Illinois
Recruiting
Illinois Cancer Specialists
Niles
Illinois
Active Not Recruiting
Maryland Oncology Hematology, P.A.
Silver Spring
Maryland
Active Not Recruiting
Minnesota Oncology Hematology, P.A.
Minneapolis
Minnesota
Active Not Recruiting
New York Oncology Hematology, P.C.
Albany
New York
Recruiting
Oncology Hematology Care Clinical Trials, LLC
Cincinnati
Ohio
Recruiting
Willamette Valley Cancer Institute and Research Center
Eugene
Oregon
Recruiting
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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