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

Non-Small Cell Lung Cancer (NSCLC) Clinical Trial

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

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer (NSCLC)

• NCT number: NCT03260491
• Study type: Interventional
• Source: Daiichi Sankyo
• Contact: (Japan sites) Daiichi Sankyo Contact for Clinical Trial Informat
• Phone: +81-3-6225-1111 (M-F 9-5 JST)
• Email: dsclinicaltrial@daiichisankyo.co.jp
• Status: Recruiting
• Phase: Phase 1
• Start date: October 30, 2017
• Completion date: December 31, 2026