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A Study of ASP2215 in Combination With Erlotinib in Subjects With Epidermal Growth Factor Receptor (EGFR) Activating Mutation-Positive (EGFRm+) Advanced Non-Small-Cell Lung Cancer (NSCLC) Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)

Non-Small-Cell Lung Cancer Clinical Trial

Official title:
A Phase 1b/2 Study of ASP2215 in Combination With Erlotinib in Subjects With EGFR Activating Mutation-Positive (EGFRm+) Advanced NSCLC Who Have Acquired Resistance to an EGFR Tyrosine Kinase Inhibitor (TKI)

Clinical Trial Summary

The purpose of the Phase 1b part of the study was to evaluate the safety and tolerability of ASP2215 in combination with erlotinib and determine the recommended phase 2 dose (RP2D) of ASP2215. The purpose of the Phase 2 part of the study was to evaluate the objective response rate (ORR) of the RP2D of ASP2215 in combination with erlotinib.

Clinical Trial Description

No patients were enrolled in the Phase 2 part of the study. Phase 2 endpoints were not analyzed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02495233
Study type Interventional
Source Astellas Pharma Inc
Contact
Status Terminated
Phase Phase 1/Phase 2
Start date September 8, 2015
Completion date September 28, 2016
View Details
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