NCT02705339

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

Genomic Landscape of EGFR Mutant NSCLC Prior to Rociletinib and at the Time of Disease Progression Following Rociletinib

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Non-Small-Cell Lung
• Non-Small Cell Lung Cancer
• Nonsmall Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Rociletinib
PROCEDURE	Biopsy	Standard of care biopsies will be taken at diagnosis and at the time of disease progression
PROCEDURE	Blood draw	-Approximately 4 teaspoons of blood will be drawn before treatment begins and at the time of disease progression to look at cell-free DNA

Timeline

• Start date: 2016-05-01
• Primary completion: 2019-11-01
• Completion: 2020-04-01
• First posted: 2016-03-10
• Last updated: 2016-05-17