drugset / Trial / NCT02186301

TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR-mutant/Metastatic NSCLC Who Have Not Had Any Previous EGFR Directed Therapy

NCT02186301

Phase 2/3 Terminated 100 enrolled Clovis Oncology, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to compare the safety and anti-tumor effect of rociletinib with erlotinib in patients whose tumors have specific EGFR mutations and who have not previously received any treatment for advanced/metastatic EGFR mutated NSCLC. This study is a 'Randomized' Study. This means that upon entering the study, patients will be randomly assigned to be dosed with either rociletinib twice a day or erlotinib once a day. Patients will continue to take either rociletinib or erlotinib until it is no longer beneficial.

Timeline

Start
2014-11
Primary completion
2017-06-28
Completion
2017-06-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Erlotinib Small molecule
Subject Rociletinib Small molecule