U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer (NCT03260491)
A Multicenter, Open-Label Phase 1 Study of U3-1402 in Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer
🩺 Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: City of Hope — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (37 Sites)
Showing the first 25 of 37 sites.
- City of Hope — Duarte, California
- University of California San Diego — La Jolla, California
- Pacific Shores Medical Group — Long Beach, California
- Winship Cancer Institute of Emory University — Atlanta, Georgia
- Massachusetts General Hospital — Boston, Massachusetts
- Dana-Farber Cancer Institute — Boston, Massachusetts
- Karmanos Cancer Institute — Detroit, Michigan
- Henry Ford Hospital — Detroit, Michigan
- NYU Langone Health - NYU Medical Oncology Associates — New York, New York
- Memorial Sloan-Kettering Cancer Center — New York, New York
- Gabrail Cancer Center (GCC) - Canton Facility — Canton, Ohio
- University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center (University of Pittsburgh Cancer Institute (UPCI) — Pittsburgh, Pennsylvania
- Sarah Cannon Research Institute/Tennesse Oncology — Nashville, Tennessee
- Oncology Consultants P.A. — Houston, Texas
- Fred Hutchinson Cancer Center — Seattle, Washington
- Northwest Medical Specialties — Tacoma, Washington
- National Cancer Center Hospital East (NCCHE) - Kashiwa Campus — Kashiwa-Shi,
- Kurume University - Kurume University Hospital - Respiratory Diseases Center — Kurume-Shi,
- Kindai University Hospital — Osaka,
- Shizuoka Cancer Center — Shizuoka,
- The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JFCR) — Tokyo,
- Netherlands Cancer Institute — Amsterdam,
- Seoul National University Hospital — Seoul,
- Asan Medical Center — Seoul,
- Samsung Medical Center — Seoul,
📞 Contact the Study Coordinator
Phone: (800) 826-4673
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Non-Small Cell Lung Cancer (NSCLC)
- Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009) — Oakland, California
- HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer — Santa Monica, California
- PCSK9 Inhibitor and PD-1 Inhibitor in Patients With Metastatic, Refractory To Prior Anti PD-1 Non-small Cell Lung — Tampa, Florida
- Study of Osimertinib and Stereotactic Ablative Radiation (SABR) in EGFR Mutant NSCLC — Duarte, California
- Study of RP1 Monotherapy and RP1 in Combination With Nivolumab (IGNYTE) — Birmingham, Alabama
Explore by condition: All Non-Small Cell Lung Cancer (NSCLC) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.