Spots Global Cancer Trial Database for HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer

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Trial Identification

Brief Title: HER3-DXd in Metastatic or Unresectable Non-Small Cell Lung Cancer

Official Title: A Multicenter, Open-Label Phase 1 Study of HER3-DXd in Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer

Study ID: NCT03260491

Conditions

Non-Small Cell Lung Cancer (NSCLC)

Interventions

HER3-DXd (FL-DP)

HER3-DXd (CTM-1 Lyo-DP)

HER3-DXd (CTM-3 Lyo-DP)

Study Description

Brief Summary: This study is designed to evaluate safety and antitumor activity of HER3-DXd in two parts: Dose Escalation and Dose Expansion. In Dose Escalation, HER3-DXd will be 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).

Detailed Description: The primary objectives are: * For Dose Escalation, to assess the safety and tolerability of HER3-DXd in the study population and to determine the recommended dose for expansion (RDE) of HER3-DXd in the study population * For Dose Expansion, to investigate the antitumor activity of HER3-DXd * For Cohort 5, investigate the antitumor activity of HER3-DXd in participants with locally advanced or metastatic NSCLC whose tumors harbor a KRAS-G12C mutation after the failure of targeted therapy The number of treatment cycles is not fixed in this study. Participants will continue study treatment (for approximately 36 months) until they decide not to (withdraw consent), their disease gets worse \[progressive disease (PD)\], or side effects become unacceptable (unacceptable toxicity) or other stopping reasons have been met.