転移性または切除不能な上皮成長因子受容体（EGFR）変異非小細胞肺癌に対するDS-1205cとゲフィチニブの併用療法

基本情報

NCT ID

NCT03599518

ステータス

中止

試験のフェーズ

第1相

試験タイプ

介入

目標被験者数

20

治験依頼者名

Daiichi Sankyo

概要

This study has two parts: dose escalation and dose expansion. The primary objectives are: * For Dose Escalation, to assess the safety and tolerability of DS-1205c when combined with gefitinib in the study population and to determine the recommended dose for expansion of DS-1205c when combined with gefitinib in the study population * For Dose Expansion, to assess the safety and tolerability of DS-1205c when combined with gefitinib in the study population. In Dose Escalation, after a 7-day run in period (Cycle 0), there will be 21-day cycles (Cycle 1 onward). In Dose Expansion, there will be 21-day cycles. The number of treatment cycles is not fixed in this study. Participants will continue study treatment for 36 months unless they decide not to (withdraw consent), their disease gets worse \[progressive disease (PD)\], or side effects become unacceptable (unacceptable toxicity).

対象疾患

介入

依頼者（Sponsor）

実施施設 (7)