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NCT03260491 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Daiichi Sankyo.

Active
Registry status
Phase 1
Development phase
312
Enrollment target
20
Study locations

NCT03260491: Active Phase 1 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Daiichi Sankyo.

NCT03260491 is a Phase 1 study of Non-small Cell Lung Cancer (NSCLC) that is active but no longer recruiting, run by Daiichi Sankyo. The registered enrollment target is 312 participants, above the 280-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (11% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03260491, a Phase 1 study of Non-small Cell Lung Cancer (NSCLC), is active but no longer recruiting, sponsored by Daiichi Sankyo.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
312 participants
Enrollment target
20
Study locations

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).

Conditions Studied

Non-small Cell Lung Cancer (NSCLC)

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
Daiichi Sankyo

236 total trials

What the registry record for NCT03260491 still lists

NCT03260491 is an interventional study that assigns participants to a tested intervention. The registered 312 participants enrollment target is mid-sized for trials with a published cap, above the 280-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (11% higher).

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.

NCT03260491 names 20 study sites across 11 states, led by Other, California, Massachusetts.

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).

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).

Who is sponsoring clinical trial NCT03260491?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Non-small Cell Lung Cancer (NSCLC)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03260491's enrollment target sits among peer trials

312 20th of 59 higher than 40 of 59 other Non-small Cell Lung Cancer (NSCLC) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03260491, the US trial registry maintained by the National Library of Medicine. NCT03260491 (mid enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.