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

Non-Small Cell Lung Cancer Clinical Trial

— PRiMAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05254795
• Other study ID #: MCC-21-LUN-126-PMC
• Status: Recruiting
• Phase: N/A
• Start date: April 13, 2022
• Est. completion date: December 2036

Study information

• Verified date: December 2023
• Source: University of Kentucky
• Contact: Jill Kolesar, PharmD, MS
• Phone: 859-323-4978
• Email: jill.kolesar[@]uky.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2036
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer

Intervention

Other:
• Molecular tumor board assisted care
Participants in this group will obtain recommendations for care from the molecular tumor board.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Jill M Kolesar	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Association of ctDNA variant allele frequency	To determine the association of ctDNA variant allele frequency with 1 year overall survival	1 year
Primary	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
Primary	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	Overall survival	Comparison of overall survival between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care	1 year
Secondary	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.	8 weeks, 12 weeks, and 1 year
Secondary	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.	At enrollment, 8 weeks, and 12 weeks.