U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer
연구 개요
This study was designed to evaluate safety and antitumor activity of HER3-DXd in two parts: Dose Escalation and Dose Expansion. In Dose Escalation, HER3-DXd was evaluated in participants with metastatic or unresectable NSCLC with epidermal growth factor receptor (EGFR) activating mutation after disease progression during/after EGFR tyrosine kinase inhibitor (TKI) therapy. In Dose Expansion, HER3-DXd will be evaluated in participants with metastatic or unresectable NSCLC with EGFR activating mutation or squamous or non-squamous NSCLC (ie, without EGFR-activating mutations) with disease progression during/after systemic treatment for locally advanced or metastatic disease. In addition, HER3-DXd will be evaluated in participants with locally advanced or metastatic NSCLC whose tumors harbor a KRAS-G12C mutation after progression on the most recent line of therapy (Cohort 5).
- 스폰서
- 협력: 머크(MSD)
- 적응증
- Non-Small Cell Lung Cancer (NSCLC)
- 중재
- HER3-DXd (FL-DP), HER3-DXd (CTM-1 Lyo-DP), HER3-DXd (CTM-3 Lyo-DP)
- 목표 등록
- 312명
- 시작일
- 2017-10-30
- 완료(예정)
- 2026-12-31
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