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NCT04743505 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)
A Phase 1 study of Metastatic Non Small Cell Lung Cancer, sponsored by Washington University School of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT04743505: Active Phase 1 study of Metastatic Non Small Cell Lung Cancer, sponsored by Washington University School of Medicine.
NCT04743505 is a Phase 1 study of Metastatic Non Small Cell Lung Cancer that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 27 participants, below the 381-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04743505, a Phase 1 study of Metastatic Non Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Washington University School of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
In this study, patients with metastatic non-small cell lung cancer that is EGFR-mutated, who have received at least 8 and not more than 12 weeks of treatment with osimertinib without demonstrating disease progression, will receive APL-101 in combination with osimertinib until progression. Dosing of APL-101 will be escalated until the maximum tolerated dose is determined, at which point 10 additional patients will be enrolled at that dose in the expansion cohort.
Primary Outcome
-Toxicity is measured by CTCAE v 5.0
Conditions Studied
Interventions
- DRUG Osimertinib
- DRUG APL-101
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2022-01-18 |
| Est. Completion | 2029-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04743505 still lists
NCT04743505 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 381-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (93% 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.
NCT04743505 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT04743505 about?
NCT04743505 is a clinical study titled "Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)". In this study, patients with metastatic non-small cell lung cancer that is EGFR-mutated, who have received at least 8 and not more than 12 weeks of treatment with osimertinib without demonstrating disease progression, will receive APL-101 in combination with osimertinib until progression. Dosing of ...
What is the current status of trial NCT04743505?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2022-01-18. Estimated completion is 2029-12-31.
What conditions does trial NCT04743505 study?
This clinical trial studies the following conditions: Metastatic Non Small Cell Lung Cancer.
What interventions are being tested in trial NCT04743505?
The interventions under investigation include: Osimertinib (DRUG), APL-101 (DRUG).
Who is sponsoring clinical trial NCT04743505?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04743505 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04743505's enrollment target sits among peer trials
27 29th of 31 higher than 3 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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