Conditions: Non-Small-Cell Lung Cancer
Keywords: Erlotinib ASP2215 NSCLC Gilteritinib Non-Small-Cell Lung Cancer
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 10
Healthy volunteers: no

Brief 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.

Detailed description:
No patients were enrolled in the Phase 2 part of the study. Phase 2 endpoints were not analyzed.

Arms:
arm 1: Gilteritinib was administered in combination with erlotinib orally once daily. arm 2: Gilteritinib was administered in combination with erlotinib orally once daily.

Interventions: intervention 1: Gilteritinib intervention 2: Erlotinib
Intervention descriptions: intervention 1: oral intervention 2: oral

Protocol document: