RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

A Multicenter, Open-Label Phase 1 Study of U3-1402 in Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer

Quick Facts

Study Start:2017-10-30
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03260491

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

(Japan sites) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
+81-3-6225-1111 (M-F 9-5 JST)
dsclinicaltrial@daiichisankyo.co.jp
(US sites) Daiichi Sankyo Contact for Clinical Trial Information
CONTACT
908-992-6400
CTRinfo_us@daiichisankyo.com

Principal Investigator

Global Clinical Lead
STUDY_DIRECTOR
Daiichi Sankyo

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
University of California San Diego
La Jolla, California, 92093
United States
Pacific Shores Medical Group
Long Beach, California, 90813
United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
United States
Karmanos Cancer Institute
Detroit, Michigan, 48201
United States
Henry Ford Hospital
Detroit, Michigan, 48202
United States
NYU Langone Health - NYU Medical Oncology Associates
New York, New York, 10016-4744
United States
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
United States
Gabrail Cancer Center (GCC) - Canton Facility
Canton, Ohio, 44718-2566
United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center (University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, 15232-1301
United States
Sarah Cannon Research Institute/Tennesse Oncology
Nashville, Tennessee, 37203
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
Northwest Medical Specialties
Tacoma, Washington, 98405
United States

Collaborators and Investigators

Sponsor: Daiichi Sankyo

  • Global Clinical Lead, STUDY_DIRECTOR, Daiichi Sankyo

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-10-30
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2017-10-30
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Oncology
  • Advanced Non-small Cell Lung Cancer
  • Metastatic
  • Unresectable
  • Epidermal growth factor receptor
  • EGFR
  • KRAS-G12C
  • Unresectable Non-small Cell Lung Cancer

Additional Relevant MeSH Terms

  • Non-Small Cell Lung Cancer (NSCLC)