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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care recipients | No Intervention | ||
| Molecular tumor board intervention | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molecular tumor board assisted care | Other | Participants in this group will obtain recommendations for care from the molecular tumor board. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in guideline concordant care |
| Measure | Description | Time Frame |
|---|---|---|
| Association of ctDNA variant allele frequency | To determine the association of ctDNA variant allele frequency with 1 year overall survival | 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Mullett, MD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | United States |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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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 |
| 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. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |