オシメルチニブ治療無効後の上皮成長因子受容体（EGFR）変異陽性局所進行性または転移性非小細胞肺癌患者におけるプラチナ製剤ベースの化学療法とアミバンタマブおよびラゼルチニブの併用とプラチナ製剤ベースの化学療法との比較試験

基本情報

NCT ID

NCT04988295

ステータス

実施中（募集終了）

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

776

治験依頼者名

Janssen Research & Development, LLC

概要

The purpose of this study is to assess the efficacy of adding lazertinib to amivantamab, carboplatin, and pemetrexed (LACP/ACP-L dosing strategies) and amivantamab, carboplatin and pemetrexed (ACP) compared with carboplatin and pemetrexed (CP) in participants with locally advanced or metastatic epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R substitution non-small cell lung cancer (NSCLC) after osimertinib failure. The purpose of the extension cohort is to further describe the safety and efficacy for the ACP-L dosing schedule versus ACP with additional data. After completion of the primary analysis, the study may eventually transition to an open-label extension (OLE) or long-term extension (LTE) phase during which participants will have the option to continue their assigned treatment.

対象疾患

介入

依頼者（Sponsor）

実施施設 (15)