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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: Active Phase 1 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Daiichi Sankyo.
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 281-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (12% lower). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A DLT is defined as any TEAE not attributable to disease or disease-related processes that occurs during the DLT evaluation period and is ≥Grade 3, as defined in the protocol. A TEAE is defined as an adverse event (AE) with a start or worsening date during the on-treatment period. A serious AE is defined as any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent o
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 |
What the registry record for NCT04676477 still lists
NCT04676477 is an interventional study that assigns participants to a tested intervention. The registered 246 participants enrollment target is mid-sized for trials with a published cap, below the 281-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (12% lower).
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 names 20 study sites across 18 states, led by 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
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Where NCT04676477's enrollment target sits among peer trials
246 25th of 59 higher than 35 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.
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