U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer
Running, not enrolling · Phase 1
Conditions studied: Non-Small Cell Lung Cancer (NSCLC)
In brief
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).
Key facts
- Study ID
- NCT03260491
- Run by
- Daiichi Sankyo
- People needed
- 312
- Starts
- 2017-10-30
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- City of Hope — Duarte, California, United States
- University of California San Diego — La Jolla, California, United States
- Pacific Shores Medical Group — Long Beach, California, United States
- Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Karmanos Cancer Institute — Detroit, Michigan, United States
- Henry Ford Hospital — Detroit, Michigan, United States
- NYU Langone Health - NYU Medical Oncology Associates — New York, New York, United States
- Memorial Sloan-Kettering Cancer Center — New York, New York, United States
- Gabrail Cancer Center (GCC) - Canton Facility — Canton, Ohio, United States
- University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center (University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh, Pennsylvania, United States
- Sarah Cannon Research Institute/Tennesse Oncology — Nashville, Tennessee, United States
- Oncology Consultants P.A. — Houston, Texas, United States
- Fred Hutchinson Cancer Center — Seattle, Washington, United States
- Northwest Medical Specialties — Tacoma, Washington, United States
- National Cancer Center Hospital East (NCCHE) - Kashiwa Campus — Kashiwa-Shi, Japan
- Kurume University - Kurume University Hospital - Respiratory Diseases Center — Kurume-Shi, Japan
- Kindai University Hospital — Osaka, Japan
- Shizuoka Cancer Center — Shizuoka, Japan
- The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JFCR) — Tokyo, Japan
- Netherlands Cancer Institute — Amsterdam, Netherlands
- Seoul National University Hospital — Seoul, South Korea
- Asan Medical Center — Seoul, South Korea
- Samsung Medical Center — Seoul, South Korea
Full record on ClinicalTrials.gov
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