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NCT06225427 · ClinicalTrials.gov registry record · Phase 1
Gilteritinib for the Treatment of ALK NSCLC
A Phase 1 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, sponsored by University of Michigan Rogel Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 3
- Study locations
NCT06225427: Recruiting Phase 1 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, sponsored by University of Michigan Rogel Cancer Center.
NCT06225427 is a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma that is actively recruiting participants, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 30 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (69% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06225427, a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Lung Non-Small Cell Carcinoma, is actively recruiting participants, sponsored by University of Michigan Rogel Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I trial is studying the safety, side effects, and best dose of gilteritinib in treating patients with stage IV ALK positive non-small cell lung cancer (NSCLC) who have progressed on other treatments. While there are many approved targeted drugs for ALK NSCLC, resistance to these drugs frequently occur. Giltertinib is a drug that is already FDA approved for the treatment of a specific type of leukemia. However, studies using ALK positive lung cancer cells demonstrate activity of gilteritinib against these resistant cells. Therefore, in this clinical trial, the investigators plan to study the effect of giltertinib in patients with ALK NSCLC.
Primary Outcome
Safety will be assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Biopsy
- DRUG Gilteritinib
- PROCEDURE Echocardiography
Study Locations (3)
California
- Cedars-Sinai Medical Center - Los Angeles
District of Columbia
- Georgetown University - Washington D.C.
Michigan
- University of Michigan Comprehensive Cancer Center - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2024-07-25 |
| Est. Completion | 2027-05 |
| Phase | Phase 1 |
What NCT06225427 shows while recruiting
NCT06225427 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (69% lower).
The record links to 2 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06225427 reports a single indexed study location in California, District of Columbia, Michigan.
Frequently Asked Questions
What is clinical trial NCT06225427 about?
NCT06225427 is a clinical study titled "Gilteritinib for the Treatment of ALK NSCLC". This phase I trial is studying the safety, side effects, and best dose of gilteritinib in treating patients with stage IV ALK positive non-small cell lung cancer (NSCLC) who have progressed on other treatments. While there are many approved targeted drugs for ALK NSCLC, resistance to these drugs fre...
What is the current status of trial NCT06225427?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2024-07-25. Estimated completion is 2027-05.
What conditions does trial NCT06225427 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Lung Non-Small Cell Carcinoma.
What interventions are being tested in trial NCT06225427?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy (PROCEDURE), Gilteritinib (DRUG), Echocardiography (PROCEDURE).
Who is sponsoring clinical trial NCT06225427?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06225427 being conducted?
This trial has 3 study locations across California, District of Columbia, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06225427's enrollment target sits among peer trials
30 48th of 81 higher than 30 of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 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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