drugset / Trial / NCT02705339

Rociletinib Genomic Landscape in Non-small Cell Lung Cancer (NSCLC)

NCT02705339

NaSingle-groupOpen-labelTreatment

Summary

Though patients whose tumors harbor EGFR T790M mutation appear to benefit from rociletinib, there is a need to understand the molecular mechanisms that lead to primary and acquired resistance to rociletinib. The investigators propose to conduct a clinical trial of rociletinib of patients with EGFR-mutant NSCLC with activating EGFR mutations (including exon 19 deletion or L858R mutation), with or without EGFR T790M mutation. In these patients, pre-treatment and post-progression biopsy specimens will be subjected to genomic analysis to fully understand the clonal evolution and the molecular mechanisms underpinning treatment resistance.

Timeline

Start
2016-05
Primary completion
2019-11
Completion
2020-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Rociletinib Small molecule 500 mg Oral
Subject Rociletinib Small molecule 625 mg Oral