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.
Description: change from baseline of tumor gene expression profile at 2 weeks. Global gene expression data will be collected using RNAseqMeasure: gene expression changes Time: baseline and 2 weeks (+/- 1 week) for each patient.
Description: 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)Measure: protein expression change Time: baseline and 2 weeks (+/- 1 week) for each patient.
Description: Correlation between the depths of tumor response (by RECIST v1.1) (percentage decrease in tumor size) with the presence of an EMT signature.Measure: Depth of Response Time: Study startup through 36 months
Description: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0Measure: Evaluation of Adverse Events Time: Study startup through 36 months
Description: Success rate of early rebiopsy in obtaining tumor samples that have evaluable material for RNA Seq and other analysesMeasure: Success rate of Repeat Biopsy Time: Study startup through 36 months
Description: Length of PFS as per RECIST 1.1Measure: Progression Free Survival Time: Study startup through 36 months
There are 2 SNPs
- Aged 18 - 85 years or older - ECOG 0-2 - Have a histologically confirmed diagnosis of lung adenocarcinoma harboring an EGFR sensitizing mutation (including, but not limited to: G719X, del exon 19, or L858R). --- L858R ---
Inclusion Criteria: - Carry a diagnosis of stage IV lung adenocarcinoma with an activating mutation determined to respond to an estimated glomerular filtration rate (EGFR) TKI, alkaline phosphatase (ALK) or ROS Proto-Oncogene 1 (ROS1) fusion or BRAF V600E. --- V600E ---
Non-Small Cell Carcinoma of Lung, TNM Stage 4 Non-Small Cell Lung Cancer EGFR Gene Mutation ALK Gene Mutation ROSE Cluster 1 BRAF V600E Carcinoma, Non-Small-Cell Lung Lung Neoplasms null --- V600E ---