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Report for Clinical Trial NCT04148066

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Track and Treat in NSCLC (TATIN) - ctDNA Guided Treatment of Early Resistance to Targeted Treatment in Patients With EGFR Positive NSCLC

The current strategy is to test for treatment resistance at the time of radiological progression and design subsequent treatment based on the mechanism of resistance. However, upon disease progression patients tend to deteriorate quickly and 30% - 40% of patients will not be in the clinical condition to receive next line treatment. Therefore, there is a potential for early resistance identification and directing treatment against it in order to improve patient outcome.

NCT04148066 Carcinoma, Non-Small-Cell Lung
MeSH:Carcinoma, Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

1 Interventions

Name: ctDNA blood sample

Description: every six weeks during treatment and upon radiological progression blood will be drawn to analyse ctDNA with Avenio ctDNA (Expanded panel) to detect all known EGFR TKI resistance mechanisms.
Type: Diagnostic Test
Group Labels: 1

Osimertinib and Crizotinib


Primary Outcomes

Description: To identify the percentage of patients in which a drug resistant clone can be detected with ctDNA before the emergence of radiological progression.

Measure: percentage of patients in which a drug resistant clone can be detected with ctDNA

Time: Trough study completion, an average of 2 years

Secondary Outcomes

Description: To determine the success rate of crizotinib and osimertinib combination treatment to eliminate MET amplification, defined by disappearance of the MET amplification clone in a subsequent ctDNA sample.

Measure: the success rate of crizotinib and osimertinib combination treatment to eliminate MET amplification

Time: Trough study completion, an average of 2 years

Purpose: Treatment

Allocation: N/A

Single Group Assignment


There is one SNP

SNPs


1 L858R

To determine the success rate of crizotinib and osimertinib combination treatment to eliminate MET amplification, defined by disappearance of the MET amplification clone in a subsequent ctDNA sample.. Inclusion Criteria: 1. Histologically confirmed metastatic NSCLC, characterized by a sensitizing exon 19 deletion or exon 21 L858R EGFR mutation. --- L858R ---

Inclusion Criteria: 1. Histologically confirmed metastatic NSCLC, characterized by a sensitizing exon 19 deletion or exon 21 L858R EGFR mutation. --- L858R ---

This technique might identify drug resistant clones before subclonal resistance (resistance of the new clone to targeted treatment) develops and allow to eliminate the new clone with short-term additional treatment, while continuing treatment of the main oncogenic driver (EGFR exon 19 del / exon 21 L858R) with the EGFR TKI. --- L858R ---



HPO Nodes


HPO: