Observational study on biomarker testing in lung cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to quantify the testing timeline, operational barriers, and outcomes of biomarker-guided therapy in a diverse patient population with early stage and advanced non-small cell lung cancer. It focuses on understanding how community-based management can improve patient convenience and reduce costs while maintaining clinical outcomes. The study will enroll treatment-naive patients and assess the impact of molecular testing on treatment choices, particularly in earlier stages of lung cancer. By identifying barriers to genomic testing, the study seeks to enhance adherence to national guidelines for tumor profiling.

Why it matters

Who can join: the full rules

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

Where it's running

• Southern Cancer Center, PC
  Daphne, Alabama, United States Recruiting
• Cancer Care Centers of Brevard, Inc.
  Palm Bay, Florida, United States Recruiting
• Affiliated Oncologists, LLC
  Chicago Ridge, Illinois, United States Recruiting
• New York Oncology Hematology, P.C.
  Albany, New York, United States Recruiting
• Oncology Hematology Care Clinical Trials, LLC
  Cincinnati, Ohio, United States Recruiting
• Willamette Valley Cancer Institute and Research Center
  Eugene, Oregon, United States Recruiting

Study contacts

• Principal investigator: Makenzi C. Evangelist, MD — New York Oncology Hematology
• Study coordinator: Andrea Glidden, BSN, OCN
• Email: andrea.glidden@mckesson.com
• Phone: 630-728-5493

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.