U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer

Active:	No
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, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT03260491

Summary

This study is designed to evaluate safety and antitumor activity of U3-1402 in two parts:
Dose Escalation and Dose Expansion.

In Dose Escalation, U3-1402 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, U3-1402 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.

Objectives

The primary objectives are:

- For Dose Escalation, to assess the safety and tolerability of U3-1402 in the study
population and to determine the recommended dose for expansion (RDE) of U3-1402 in the
study population

- For Dose Expansion, to investigate the antitumor activity of U3-1402

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
404-778-5180
winshipcancer.emory.edu

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