A comparison of baseline tumor characteristics in oncogene-driven cancers to tumor characteristics after early response to Tyrosine Kinase Inhibitor (TKI) targeted treatment will allow identification of early adaptive mechanisms of cell survival. This will facilitate targeting and termination of these survival/ resistance pathways before they develop with rational combinations of therapeutic agents to improve outcomes.
Carry a diagnosis of locally advanced or stage IV NSCLC responsive to targeted therapies (per current NCCN guidelines)
Aged 18 years or older
ECOG 0-2
Have a histologically confirmed diagnosis of NSCLC harboring an activating mutation responsive to targeted therapy (per NCCN guidelines)
Concurrent health problem which would preclude tissue biopsy (e.g. hemophilia or other bleeding predisposition).
Patients whose only biopsy source would involve sampling an anatomic area that carries an unacceptably high procedural risk (e.g. pericardium or kidney) as deemed by the treating physician or by a proceduralist performing the biopsy.
Patients whose only biopsy source involves a sample that may not be evaluable due to insufficient genomic material (such as cerebrospinal or ascitic fluid) as deemed by the treating physician. .
Planned follow up on therapy outside of the University of Colorado Health System
Subjects who have a diagnosis of State IV Lung Adenocarcinoma with EGFR activating mutation
Other
Other
Not listed
gene expression changes
change from baseline of tumor gene expression profile at 2 weeks. Global gene expression data will be collected using RNAseq
protein expression change
change from baseline of protein gene expression profile at 2 weeks as measured by multiplex protein assay (proteins to be assayed include: e-cadherin, vimentin, fibronectin, CD4, CD8, CD14, CD16, CD206, PDL1, and CSF1R)
Depth of Response
Correlation between the depths of tumor response (by RECIST v1.1) (percentage decrease in tumor size) with the presence of an EMT signature.
Evaluation of Adverse Events
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Success rate of Repeat Biopsy
Success rate of early rebiopsy in obtaining tumor samples that have evaluable material for RNA Seq and other analyses
Progression Free Survival
Length of PFS as per RECIST 1.1
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