Precision Medicine Randomized Clinical Trial Comparing Molecular Tumor Board Assisted Care to Usual Care

NCT05254795 | Active Not Recruiting DMC

• 1 other identifier: MCC-21-LUN-126-PMC
• Study Type: interventional
• Target: 659
• Locations: 1 country
• Sites: 1

Brief Summary

This trial will compare Molecular Tumor Board (MTB) assisted care to usual care for patients who have newly diagnosed histologically or cytologically confirmed stage IIb-IV Non-Small Cell Lung Cancer (NSCLC) and are planning to undergo treatment for their cancer.

Conditions

Non-Small Cell Lung Cancer

Keywords

Molecular tumor board

Outcome Measures

Primary Outcomes (2)

• Overall survival

  Overall survival 1 year survival between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care.

  1 year

• Change in quality of life (QOL)

  Quality of life will be assessed via the FACT-L (The Functional Assessment of Cancer Therapy - Lung). FACT-L has 5 areas of measurement: physical wellbeing, social/family wellbeing, emotional wellbeing, functional wellbeing, and an additional concerns list of problems specific to lung cancer. Areas are measured on a 5-point Likert-type scale of 0-4. The FACT-L subscales can be scored to yield a total score, subscale scores, as well as the Trial Outcome Index (TOI), which reflects the physical wellbeing, functional wellbeing, and lung cancer symptom subscales. TOI scores range from 0-84, with a higher score reflecting better QOL. Total FACT-G scores (physical, social, emotional, and functional wellbeing subscales) range from 0-108, with higher scores reflecting better QOL. The lung cancer subscale (i.e., additional concerns subscale) can range from 0-28 (only 7 items are scored), with higher scores reflecting better QOL.

  At enrollment, 8 weeks, and 12 weeks.

Secondary Outcomes (3)

• Overall survival

  1 year

• Change in guideline concordant care

  8 weeks, 12 weeks, and 1 year

• Change in satisfaction with treatment

  At enrollment, 8 weeks, and 12 weeks.

Other Outcomes (1)

• Association of ctDNA variant allele frequency

  1 year

Study Arms (2)

Usual care recipients

NO INTERVENTION

Molecular tumor board intervention

EXPERIMENTAL

Other: Molecular tumor board assisted care

Interventions

Molecular tumor board assisted care OTHER

Participants in this group will obtain recommendations for care from the molecular tumor board.

Molecular tumor board intervention

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Timothy Mullett: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Timothy Mullett, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: February 24, 2022
• Study Start: April 13, 2022
• Primary Completion (Estimated): December 22, 2026
• Study Completion (Estimated): December 22, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)