SNPMiner Trials by Shray Alag


SNPMiner SNPMiner Trials (Home Page)


Report for Clinical Trial NCT03042221

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Early Rebiopsy to Identify Mechanisms and Biomarkers of Tumor Cell Survival Following Targeted Therapy in Patients With EGFR, ALK, ROS1 or BRAF Mutations.

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.

NCT03042221 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
MeSH:Carcinoma, Non-Small-Cell Lung Lung Neoplasms
HPO:Neoplasm of the lung Non-small cell lung carcinoma


Primary Outcomes

Description: change from baseline of tumor gene expression profile at 2 weeks. Global gene expression data will be collected using RNAseq

Measure: 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.

Secondary Outcomes

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

Other Outcomes

Description: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Measure: 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 analyses

Measure: Success rate of Repeat Biopsy

Time: Study startup through 36 months

Description: Length of PFS as per RECIST 1.1

Measure: Progression Free Survival

Time: Study startup through 36 months

Time Perspective: Other

Other


There are 2 SNPs

SNPs


1 L858R

- 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 ---


2 V600E

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 ---



HPO Nodes


HPO: