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

Active:	Yes
Cancer Type:	Lung Cancer	NCT ID:	NCT03260491
Trial Phases:	Phase I	Protocol IDs:	U31402-A-U102 (primary) NCI-2018-00060 2017-000543-41
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Daiichi Sankyo
NCI Full Details:	http://clinicaltrials.gov/show/NCT03260491

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).

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.