Comparing specialized cancer care to standard treatment for lung cancer
Precision Medicine Randomized Clinical Trial Comparing Molecular Tumor Board Assisted Care to Usual Care
This study is testing if a specialized team approach to lung cancer treatment helps people with newly diagnosed stage IIb-IV Non-Small Cell Lung Cancer do better than the usual treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT05254795 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of Molecular Tumor Board (MTB) assisted care compared to usual care for patients with newly diagnosed stage IIb-IV Non-Small Cell Lung Cancer (NSCLC) who are preparing for treatment. The MTB approach involves a team of specialists who analyze the molecular characteristics of the tumor to tailor treatment plans. Participants must have confirmed NSCLC and no prior systemic therapies, although prior surgery or radiation is permitted. The goal is to determine if MTB-assisted care leads to better outcomes than standard treatment protocols.
Who should consider this trial
Good fit: Ideal candidates are individuals with newly diagnosed stage IIb-IV NSCLC who are planning to start treatment and have not received prior systemic therapies.
Not a fit: Patients with uncontrolled intercurrent illnesses or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective treatment options for patients with lung cancer.
How similar studies have performed: Other studies have shown promise in using molecular tumor boards for personalized cancer treatment, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically suspected or histologically confirmed stage IIb-IV NSCLC who are planning to undergo treatment * No prior systemic therapies for NSCLC, with the exception of adjuvant therapy for early stage NSCLC. Prior surgery and/or radiation is allowed. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with targeted therapy, in the opinion of the treating physician. * Pregnancy
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Timothy Mullett, MD — University of Kentucky
- Study coordinator: Timothy Mullett, MD
- Email: timothy.mullett@uky.edu
- Phone: 8592186647
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.