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NCT03810807 · ClinicalTrials.gov registry record · Phase 1
Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer
A Phase 1 study of Metastatic Non Small Cell Lung Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 7
- Study locations
NCT03810807: Completed Phase 1 study of Metastatic Non Small Cell Lung Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT03810807 is a Phase 1 study of Metastatic Non Small Cell Lung Cancer that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 22 participants, below the 382-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03810807, a Phase 1 study of Metastatic Non Small Cell Lung Cancer, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to test the safety of dacomitinib and osimertinib, at increasing doses, to find out what effects, if any, this combination of drugs has on people with metastatic EGFR mutant lung cancer that has not been treated with an EGFR TKI.
Primary Outcome
The MTD will be defined as the highest dose at which not more than 1/6 of the patients experience dose limiting toxicity (DLT). DLT is defined as any of the toxicity events described below that occurs within cycle 1 of treatment with the combination of dacomitinib and osimertinib.
Conditions Studied
Interventions
- DRUG Osimertinib
- DRUG Dacomitinib
Study Locations (7)
New York
- Memorial Sloan Kettering Commack - Commack
- Memorial Sloan Kettering Westchester - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge - Basking Ridge
- Memorial Sloan Kettering Monmouth - Middletown
- Memorial Sloan Kettering Bergen - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2019-01-17 |
| Est. Completion | 2025-12-15 |
| Phase | Phase 1 |
What the finished NCT03810807 record still lists
NCT03810807 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 382-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Metastatic Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Osimertinib is the first listed.
NCT03810807 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT03810807 about?
NCT03810807 is a clinical study titled "Study of Dacomitinib and Osimertinib for Patients With Advanced EGFR Mutant Lung Cancer". The purpose of this study is to test the safety of dacomitinib and osimertinib, at increasing doses, to find out what effects, if any, this combination of drugs has on people with metastatic EGFR mutant lung cancer that has not been treated with an EGFR TKI.
What is the current status of trial NCT03810807?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2019-01-17. Estimated completion is 2025-12-15.
What conditions does trial NCT03810807 study?
This clinical trial studies the following conditions: Metastatic Non Small Cell Lung Cancer.
What interventions are being tested in trial NCT03810807?
The interventions under investigation include: Osimertinib (DRUG), Dacomitinib (DRUG).
Who is sponsoring clinical trial NCT03810807?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03810807 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03810807's enrollment target sits among peer trials
22 30th of 31 higher than 2 of 31 other Metastatic Non Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Non Small Cell Lung Cancer 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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