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

NCT ID: NCT05254795

Last Updated: 2025-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-13

Study Completion Date

2036-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Usual care recipients

Group Type NO_INTERVENTION

No interventions assigned to this group

Molecular tumor board intervention

Group Type EXPERIMENTAL

Molecular tumor board assisted care

Intervention Type OTHER

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

Interventions

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Molecular tumor board assisted care

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

Timothy Mullett

OTHER

Sponsor Role lead

Responsible Party

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Timothy Mullett

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Timothy Mullett, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

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University of Kentucky

Lexington, Kentucky, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Timothy Mullett, MD

Role: CONTACT

8592186647

Facility Contacts

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Timothy Mullett, MD

Role: primary

Other Identifiers

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MCC-21-LUN-126-PMC

Identifier Type: -

Identifier Source: org_study_id

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