This phase II trial tests compares usual care to molecular tumor board (MTB)-assisted care in treating patients with stage IIB-IV non-small cell lung cancer (NSCLC). A molecular tumor board is a group of scientists and doctors with expertise in cancer diagnosis and treatment who make recommendations for treatment. They base those recommendations on the relevant gene alterations identified by next generation sequencing (NGS) testing and available treatments that target those alterations. NGS is a technology for determining the sequence of deoxyribonucleic acid (DNA) or ribonucleic acid (RNA). Using this information, doctors can identify treatments that target the genetic alterations found in the patient's tumor. The purpose of this trial is to study the effect of the Molecular Tumor Board review on treatment outcomes in patients with NSCLC.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05254795.
PRIMARY OBJECTIVES:
I. To compare 1 year overall survival between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care.
II. To compare health-related quality of life between with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care.
SECONDARY OBJECTIVES:
I. To compare 2 year and 3 year overall survival between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care.
II. To compare time on treatment between with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care for up to 2 lines of therapy.
III. To compare overall survival between individuals with stage IIb-IV NSCLC who receive MTB assisted care to those who receive usual care for up to 3 lines of therapy.
IV. To compare 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 for up to 3 lines of therapy.
V. 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).
VI. To determine rationale for lack of guideline concordant care in the opinion of the treating physician.
VII. To determine the frequency of compliance with MTB recommendations.
VIII. To determine the influence of social and economic status on study outcomes.
IX. To compare 2 year and 3 year overall survival between randomized sites and the pilot site.
X. To determine if patient education videos improve patient knowledge of NGS.
XI. To determine acceptability of patient videos to patients.
EXPLORATORY OBJECTIVE:
I. To determine the association of circulating tumor-derived DNA (ctDNA) variant allele frequency with 2 year overall survival.
OUTLINE: Patients are randomized to 1 of 2 arms. All University of Kentucky Markey Cancer Center patients are assigned to Arm II.
ARM I: Patients receive usual care. Patients also receive educational video at baseline.
ARM II: Patients receive MTB-assisted care. Patients also receive educational video at baseline. Patients also undergo blood sample collection on study.
Patients are followed for up to 5 years or until death, whichever comes first.
Lead OrganizationUniversity of Kentucky/Markey Cancer Center
Principal InvestigatorTimothy William Mullett
