U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer
Public ClinicalTrials.gov record NCT03260491. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Open-Label Phase 1 Study of U3-1402 in Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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).
Study identification
- NCT ID
- NCT03260491
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 312 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 30, 2017 (Actual)
- Primary completion
- Dec 1, 2025 (Actual)
- Completion
- Jul 30, 2027 (Estimated)
- Last update posted
- Oct 26, 2026
2017 – 2027
United States locations
- U.S. sites
- 16
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | — |
| University of California San Diego | La Jolla | California | 92093 | — |
| Pacific Shores Medical Group | Long Beach | California | 90813 | — |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| NYU Langone Health - NYU Medical Oncology Associates | New York | New York | 10016-4744 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| Gabrail Cancer Center (GCC) - Canton Facility | Canton | Ohio | 44718-2566 | — |
| University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center (University of Pittsburgh Cancer Institute (UPCI) | Pittsburgh | Pennsylvania | 15232-1301 | — |
| Sarah Cannon Research Institute/Tennesse Oncology | Nashville | Tennessee | 37203 | — |
| Oncology Consultants P.A. | Houston | Texas | 77030 | — |
| Fred Hutchinson Cancer Center | Seattle | Washington | 98109 | — |
| Northwest Medical Specialties | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03260491, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 26, 2026 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03260491 live on ClinicalTrials.gov.