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Active, not recruitingNCT05254795PRiMALUpdated Mar 6, 2026

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

An interventional study of Molecular tumor board assisted care in Non-Small Cell Lung Cancer, sponsored by Timothy Mullett. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by Timothy Mullett · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
659
Allocation
Randomized
Ages
18 Years to 120 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Non-Small Cell Lung Cancer

Keywords

  • Molecular tumor board
03

In context

Carcinoma, Non-Small-Cell Lung

6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.

This study's enrollment of 659 is above the median of 62 across 5,213 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Browse Carcinoma, Non-Small-Cell Lung studies →

Lead sponsor

Timothy Mullett is the lead sponsor of 5 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
659 participants (actual)

Study arms

  • No intervention
    Usual care recipients
  • Experimental
    Molecular tumor board intervention

    Other: Molecular tumor board assisted care

Interventions

  • OtherMolecular tumor board assisted care

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

  2. 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.

    Time frame: At enrollment, 8 weeks, and 12 weeks.

Secondary outcomes

  1. Overall survival

    Comparison of overall survival between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care

    Time frame: 1 year

  2. Change in guideline concordant care

    Comparison of guideline concordant care (specifically receiving next generation sequencing (NGS) testing and treatments based on identified mutations) between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care.

    Time frame: 8 weeks, 12 weeks, and 1 year

  3. Change in satisfaction with treatment

    To compare satisfaction with treatment between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care, including financial, psychosocial, and physical measures of satisfaction using the Functional Assessment of Chronic Illness Therapy (FACIT) - Treatment Satisfaction - General (TSG) (version 4). The FACIT-TSG is an 8-item questionnaire, with each item score ranging from 0 ("not at all") to 4 ("very much"). Total scores range from 0 to 32 with higher scores indicating greater satisfaction with treatment.

    Time frame: At enrollment, 8 weeks, and 12 weeks.

Other outcomes

  1. Association of ctDNA variant allele frequency

    To determine the association of ctDNA variant allele frequency with 1 year overall survival

    Time frame: 1 year

07

Study locations

1 site
  • University of Kentucky
    Lexington, Kentucky 40506, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05254795
Lead sponsor
Timothy Mullett
Collaborators
Eli Lilly and Company
Responsible party
Timothy Mullett (Professor, University of Kentucky) — Sponsor-investigator
First posted
Feb 24, 2022
Start date
Apr 13, 2022
Primary completion
Dec 22, 2026 (estimated)
Completion
Dec 22, 2026 (estimated)
Last update
Mar 6, 2026

Study contacts

Timothy Mullett, MD
principal investigator · University of Kentucky

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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