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ACTIVE NOT RECRUITING Phase 2

HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer

NCT04619004 · View on ClinicalTrials.gov ↗

Study Summary

This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.

Interventions

  • DRUG Patritumab Deruxtecan (Fixed dose)
  • DRUG Patritumab Deruxtecan (Up-Titration)

Study Locations (20)

Florida

  • Florida Cancer Specialists - South — Fort Myers
  • AdventHealth Orlando — Orlando
  • Memorial Healthcare System — Pembroke Pines
  • Florida Cancer Specialist-North — St. Petersburg
  • Florida Cancer Specialists-Panhandle — Tallahassee
  • H. Lee Moffitt Cancer Center & Research Institute — Tampa
  • Florida Cancer Specialists-East — West Palm Beach

California

  • City of Hope — Duarte
  • Moores Cancer Center at the UC San Diego Health — La Jolla
  • Pacific Shores Medical Group — Long Beach
  • USC Norris Comprehensive Cancer Center — Los Angeles
  • University of California at Irvine — Orange
  • Cedars Sinai — West Hollywood

Massachusetts

  • Massachusetts General Hospital (MGH) - Hematology/Oncology — Boston
  • Beth Israel Deaconess Medical Center, Harvard Medical School — Boston

Arizona

  • Banner MD Anderson Cancer Center — Gilbert

Colorado

  • University of Colorado Denver - Anschutz Medical Campus — Aurora

Georgia

  • Emory University — Dunwoody

Illinois

  • Northwestern University — Chicago

Maryland

  • University of Maryland - Marlene and Stewart Greenebaum Cancer Center — Baltimore

Trial Details

FieldValue
Enrollment Target 277 participants
Start Date 2021-02-02
Est. Completion 2026-01-30
Phase Phase 2

Sponsor

Daiichi Sankyo

157 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04619004

The ClinicalTrials.gov registry entry for NCT04619004 describes a study currently listed as active not recruiting. It is categorized as Phase 2, 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 277 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 2 conditions, with Non-Small Cell Lung Cancer Metastatic appearing as the primary indexed condition, and to 2 interventions — of which Patritumab Deruxtecan (Fixed dose) 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: NCT04619004 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, 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 NCT04619004 about?

NCT04619004 is a clinical study titled "HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer". This study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy...

What is the current status of trial NCT04619004?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 277 participants. The study started on 2021-02-02. Estimated completion is 2026-01-30.

What conditions does trial NCT04619004 study?

This clinical trial studies the following conditions: Non-Small Cell Lung Cancer Metastatic, Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04619004?

The interventions under investigation include: Patritumab Deruxtecan (Fixed dose) (DRUG), Patritumab Deruxtecan (Up-Titration) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04619004?

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 NCT04619004 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. 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