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

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ClinicalTrials.gov Identifier: NCT05254795
Recruitment Status : Recruiting
First Posted : February 24, 2022
Last Update Posted : December 14, 2023
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Jill M Kolesar, University of Kentucky

Study Description
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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.

Condition or disease Intervention/treatment Phase
Non-Small Cell Lung Cancer Other: Molecular tumor board assisted care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Precision Medicine Randomized Clinical Trial Comparing Molecular Tumor Board Assisted Care to Usual Care
Actual Study Start Date : April 13, 2022
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2036

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Usual care recipients
Experimental: Molecular tumor board intervention Other: Molecular tumor board assisted care
Participants in this group will obtain recommendations for care from the molecular tumor board.


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
    Overall survival 1 year survival between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care.

  2. Change in quality of life (QOL) [ Time Frame: At enrollment, 8 weeks, and 12 weeks. ]
    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.


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 1 year ]
    Comparison of overall survival between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care

  2. Change in guideline concordant care [ Time Frame: 8 weeks, 12 weeks, and 1 year ]
    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.

  3. Change in satisfaction with treatment [ Time Frame: At enrollment, 8 weeks, and 12 weeks. ]
    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.


Other Outcome Measures:
  1. Association of ctDNA variant allele frequency [ Time Frame: 1 year ]
    To determine the association of ctDNA variant allele frequency with 1 year overall survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05254795


Contacts
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Contact: Jill Kolesar, PharmD, MS 859-323-4978 jill.kolesar@uky.edu

Locations
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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Jill Kolesar, PharmD, MS         
Sponsors and Collaborators
Jill M Kolesar
Eli Lilly and Company
Investigators
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Principal Investigator: Jill Kolesar, PharmD, MS University of Kentucky
More Information
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Responsible Party: Jill M Kolesar, Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT05254795    
Other Study ID Numbers: MCC-21-LUN-126-PMC
First Posted: February 24, 2022    Key Record Dates
Last Update Posted: December 14, 2023
Last Verified: December 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jill M Kolesar, University of Kentucky:
Molecular tumor board
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases