The primary objective is to 1- Identify differences between pretreatment and early treatment tumor samples in patients whose tumors contain activating mutations and who will be treated with targeted agents as first-line therapy. a. Measurement of gene expression signatures of pre-and early treatment tumors b. Measurement of immunohistochemistry biomarkers of pre- and early treatment tumors tumors Secondary Objectives: 2- Identify pre-therapy predictive markers that can be used to determine which tumors will undergo EMT or activation of other bypass pathways following targeted therapy. 3- Determine if there is a correlation between the depths of tumor response (by RECIST v1.1) (percentage decrease in tumor size) with the presence of an EMT signature. 4- Estimate success rate of early rebiopsy in obtaining tumor samples that have evaluable material for RNA Seq and other analyses. 5- Determine adverse event rate associated with rapid second biopsy Exploratory Objectives: 6- Determine if there is an association between progression free survival and bypass pathway activation status 7- Determine whether there is evidence of bypass pathway activation in circulating tumor cells. Enrolled subjects will be asked to have one - two research tumor biopsies of predetermined target lesions. If they do not have tissue from the target lesion that was previously collected, they will be asked to allow study investigators to use the tissue as part of this study and will have one biopsy before they begin their targeted therapy, and the second biopsy about two weeks later. The subject may also have a third SOC biopsy if tumor progresses.More
3.1. Study Population INCLUSION 1. Carry a diagnosis of stage IV NSCLC with an activating mutation documented to respond to an EGFR TKI, ALK or ROS1 fusion or BRAF V600E activating mutation 2. Aged 18 - 85 years or older 3. ECOG 0-2 4. Have a histologically confirmed diagnosis of NSCLC harboring an EGFR, ALK, ROS1 or BRAF V600E activating mutation 5. No prior oncogene targeted therapy for metastatic disease, chemotherapy, immunotherapy permitted (bevacizumab, cetuximab permitted). 6. Planned treatment with targeted therapy specific to the oncogene driver mutation. 7. Patients must have at least one site of measurable disease ≥ least 2cm. 8. Primary disease site or site of metastatic disease must be amenable to biopsy. 9. Patients must have the ability to understand and willingness to sign an informed consent document.
Detailed Eligibility: Same as key eligibility
Not Applicable - Describes studies without FDA-defined phases, including studies of devices or behavioral interventions.
Lone Tree Medical Center
University of Colorado Hospital
Erin Schenk, MD, PhD
Protocol Number: 15-2316
More information available at ClinicalTrials.gov: NCT03042221
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