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NCT04619004 · ClinicalTrials.gov registry record · Phase 2
HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
A Phase 2 study of Non Small Cell Lung Cancer Metastatic and Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor, sponsored by Daiichi Sankyo.
- Active
- Registry status
- Phase 2
- Development phase
- 277
- Enrollment target
- 20
- Study locations
NCT04619004: Active Phase 2 study of Non Small Cell Lung Cancer Metastatic and Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor, sponsored by Daiichi Sankyo.
NCT04619004 is a Phase 2 study of Non Small Cell Lung Cancer Metastatic and Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor that is active but no longer recruiting, run by Daiichi Sankyo. The registered enrollment target is 277 participants, below the 419-participant average among 16 other Non Small Cell Lung Cancer Metastatic trials with a reported enrollment target (34% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04619004, a Phase 2 study of Non Small Cell Lung Cancer Metastatic and Non-Small Cell Lung Cancer With Mutation in Epidermal Growth Factor Receptor, is active but no longer recruiting, sponsored by Daiichi Sankyo.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 277 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
ORR is defined as the proportion of participants with a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) as assessed by BICR per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions based on RECIST v1.1.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 277 participants |
| Start Date | 2021-02-02 |
| Est. Completion | 2026-01-30 |
| Phase | Phase 2 |
What the registry record for NCT04619004 still lists
NCT04619004 is an interventional study that assigns participants to a tested intervention. The registered 277 participants enrollment target is mid-sized for trials with a published cap, below the 419-participant average among 16 other Non Small Cell Lung Cancer Metastatic trials with a reported enrollment target (34% lower).
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.
NCT04619004 names 20 study sites across 8 states, led by Florida, California, Massachusetts.
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.
What interventions are being tested in trial NCT04619004?
The interventions under investigation include: Patritumab Deruxtecan (Fixed dose) (DRUG), Patritumab Deruxtecan (Up-Titration) (DRUG).
Who is sponsoring clinical trial NCT04619004?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
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.
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Where NCT04619004's enrollment target sits among peer trials
277 5th of 16 higher than 12 of 16 other Non Small Cell Lung Cancer Metastatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non Small Cell Lung Cancer Metastatic 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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