Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04676477 · ClinicalTrials.gov registry record · Phase 1

HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated 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
246
Enrollment target
20
Study locations

NCT04676477 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 246 participants, below the 284-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (13% lower). The trial reports 20 study locations across 18 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04676477, 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
246 participants
Enrollment target
20
Study locations

Study Summary

This study includes a Dose Escalation Part to identify the recommended combination dose (RCD) and a Dose Expansion Part to further evaluate efficacy and safety. The primary objectives: Dose Escalation: To assess the safety and tolerability of HER3-DXd (patritumab deruxtecan; U3-1402) and osimertinib in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib, and to determine the recommended combination dose (RCD). Second-Line Dose Expansion Arm 1 and Arm 1b: To assess the preliminary antitumor activity of HER3-DXd and osimertinib in subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib. Note: One or both of the study arms may open with one or two distinct dosing schedules. Second-Line Dose Expansion Arm 2: To assess the preliminary antitumor activity of HER3-DXd monotherapy in subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation with tumor progression after treatment with osimertinib. First-Line Dose Expansion Cohorts 3, 4a, and 4b: To assess the preliminary antitumor activity of HER3-DXd and osimertinib in subjects with locally advanced or metastatic NSCLC with an EGFR exon 19 deletion or L858R mutation without prior systemic treatment for locally advanced or metastatic disease.

Conditions Studied

Non-small Cell Lung Cancer (NSCLC)

Interventions

  • DRUG Osimertinib
  • DRUG HER3-DXd

Study Locations (20)

Massachusetts

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

New York

  • Columbia University Irving Medical Center - New York
  • Memorial Sloan Kettering Cancer Center - New York

California

  • UCLA - Santa Monica

Connecticut

  • Yale University School of Medicine - Yale-New Haven Hospital - New Haven

District of Columbia

  • Georgetown University Medical Center - Washington D.C.

Illinois

  • Northwestern University Feinberg School of Medicine - Chicago

Michigan

  • Henry Ford Cancer Institute - Detroit

New Hampshire

  • Dartmouth-Hitchcock Medical Center - Lebanon

Trial Details

FieldValue
Enrollment Target 246 participants
Start Date 2021-06-11
Est. Completion 2027-04-30
Phase Phase 1

Sponsor

Daiichi Sankyo

236 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04676477

The ClinicalTrials.gov registry entry for NCT04676477 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 246 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 284-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (13% lower). The listed sponsor is Daiichi Sankyo, which has 236 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 2 interventions - of which Osimertinib is the first listed.

NCT04676477 reports 20 study locations spanning 18 distinct geographic areas - top geographies include Massachusetts, New York, California.

Frequently Asked Questions

What is clinical trial NCT04676477 about?

NCT04676477 is a clinical study titled "HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer". This study includes a Dose Escalation Part to identify the recommended combination dose (RCD) and a Dose Expansion Part to further evaluate efficacy and safety. The primary objectives: Dose Escalation: To assess the safety and tolerability of HER3-DXd (patritumab deruxtecan; U3-1402) and osimertin...

What is the current status of trial NCT04676477?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 246 participants. The study started on 2021-06-11. Estimated completion is 2027-04-30.

What conditions does trial NCT04676477 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).

What interventions are being tested in trial NCT04676477?

The interventions under investigation include: Osimertinib (DRUG), HER3-DXd (DRUG).

Who is sponsoring clinical trial NCT04676477?

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

Where is trial NCT04676477 being conducted?

This trial has 20 study locations across California, Connecticut, District of Columbia, Illinois, Massachusetts. 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.

Explore more on PlainTrial

Non-small Cell Lung Cancer (NSCLC)

All registered trials for this condition

California

All trials with a study site in California

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.