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ACTIVE NOT RECRUITING Phase 1

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

NCT03260491 · View on ClinicalTrials.gov ↗

Study Summary

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).

Interventions

  • DRUG HER3-DXd (FL-DP)
  • DRUG HER3-DXd (CTM-1 Lyo-DP)
  • DRUG HER3-DXd (CTM-3 Lyo-DP)

Study Locations (20)

Other

  • 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

California

  • City of Hope — Duarte
  • University of California San Diego — La Jolla
  • Pacific Shores Medical Group — Long Beach

Massachusetts

  • Massachusetts General Hospital — Boston
  • Dana-Farber Cancer Institute — Boston

Michigan

  • Karmanos Cancer Institute — Detroit
  • Henry Ford Hospital — Detroit

New York

  • NYU Langone Health - NYU Medical Oncology Associates — New York
  • Memorial Sloan-Kettering Cancer Center — New York

Washington

  • Fred Hutchinson Cancer Center — Seattle
  • Northwest Medical Specialties — Tacoma

Georgia

  • Winship Cancer Institute of Emory University — Atlanta

Ohio

  • Gabrail Cancer Center (GCC) - Canton Facility — Canton

Trial Details

FieldValue
Enrollment Target 312 participants
Start Date 2017-10-30
Est. Completion 2026-12-31
Phase Phase 1

Sponsor

Daiichi Sankyo

157 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03260491

The ClinicalTrials.gov registry entry for NCT03260491 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 312 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Daiichi Sankyo, which has 157 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Non-Small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 3 interventions — of which HER3-DXd (FL-DP) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03260491 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03260491 about?

NCT03260491 is a clinical study titled "U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer". 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 dis...

What is the current status of trial NCT03260491?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 312 participants. The study started on 2017-10-30. Estimated completion is 2026-12-31.

What conditions does trial NCT03260491 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer (NSCLC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03260491?

The interventions under investigation include: HER3-DXd (FL-DP) (DRUG), HER3-DXd (CTM-1 Lyo-DP) (DRUG), HER3-DXd (CTM-3 Lyo-DP) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03260491?

This trial is sponsored by Daiichi Sankyo, which has 157 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03260491 being conducted?

This trial has 20 study locations across California, Georgia, Massachusetts, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial