Non-Small Cell Lung Cancer
Conditions
Keywords
Molecular tumor board
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.
Interventions
OTHERMolecular tumor board assisted care
Participants in this group will obtain recommendations for care from the molecular tumor board.
Sponsors
Timothy Mullett
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 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. |
| Change in quality of life (QOL) | 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
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | 1 year | Comparison of overall survival between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care |
| Change in guideline concordant care | 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. |
| Change in satisfaction with treatment | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTimothy Mullett, MD
University of Kentucky
Outcome results
None listed