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HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer
NCT04676477 · View on ClinicalTrials.gov ↗
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
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
| Field | Value |
|---|---|
| Enrollment Target | 246 participants |
| Start Date | 2021-06-11 |
| Est. Completion | 2027-04-30 |
| Phase | Phase 1 |
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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. 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 246 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 2 interventions — of which Osimertinib 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: NCT04676477 reports 20 study locations spanning 18 distinct geographic areas — top geographies include Massachusetts, New York, California. 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 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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04676477?
The interventions under investigation include: Osimertinib (DRUG), HER3-DXd (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04676477?
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 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.
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