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NCT05987644 · ClinicalTrials.gov registry record · Phase 1
Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements
A Phase 1 study of Lung Cancer and NSCLC, sponsored by Joshua Palmer.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
- 3
- Study locations
NCT05987644: Recruiting Phase 1 study of Lung Cancer and NSCLC, sponsored by Joshua Palmer.
NCT05987644 is a Phase 1 study of Lung Cancer and NSCLC that is actively recruiting participants, run by Joshua Palmer. The registered enrollment target is 56 participants, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05987644, a Phase 1 study of Lung Cancer and NSCLC, is actively recruiting participants, sponsored by Joshua Palmer.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
- 3
- Study locations
Study Summary
This study will consist of a Phase 1b and Phase 2 portion. The Phase 1b portion will enroll first followed by the Phase 2 portion. Each cycle of treatment = 28 days. Subjects will receive alectinib twice daily. Those in the Phase 1b portion will receive alectinib alone. Those in Phase 2 Arm A will receive alectinib alone. Those in Phase 2, Arm B will receive SRS + alectinib. A maximum of 25 cycles (2 years) of alectinib may be administered on study.
Primary Outcome
Neurological status will be measured by a composite endpoint of: -Inntracranial progression(icPD) by RANO-BM criteria or death during the first 12 months. OR -Symptomatic radiation necrosis during the first 12 months. Symptomatic radiation necrosis is defined as requiring initiation of or increased dose of steroids or resulting in seizures or requirement of AEDs or requirement of hospitalization or surgery. OR -Cognitive decline, defined as 1 standard deviation decline from baseline cogniti
Conditions Studied
Interventions
- RADIATION Stereotactic Radiosurgery
- DRUG Alectinib
Study Locations (3)
California
- Stanford University - Stanford
Colorado
- University of Colorado Cancer Center - Aurora
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2024-03-07 |
| Est. Completion | 2027-06 |
| Phase | Phase 1 |
What NCT05987644 shows while recruiting
NCT05987644 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 936-participant average among 409 other Lung Cancer trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Stereotactic Radiosurgery is the first listed.
NCT05987644 reports a single indexed study location in California, Colorado, Ohio.
Frequently Asked Questions
What is clinical trial NCT05987644 about?
NCT05987644 is a clinical study titled "Delayed or Upfront Brain RAdiotherapy in Treatment naïve Lung Cancer Patients With Asymptomatic or Minimally Symptomatic Brain Metastases and ALK rEarrangements". This study will consist of a Phase 1b and Phase 2 portion. The Phase 1b portion will enroll first followed by the Phase 2 portion. Each cycle of treatment = 28 days. Subjects will receive alectinib twice daily. Those in the Phase 1b portion will receive alectinib alone. Those in Phase 2 Arm A will ...
What is the current status of trial NCT05987644?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2024-03-07. Estimated completion is 2027-06.
What conditions does trial NCT05987644 study?
This clinical trial studies the following conditions: Lung Cancer, NSCLC, Brain Metastases.
What interventions are being tested in trial NCT05987644?
The interventions under investigation include: Stereotactic Radiosurgery (RADIATION), Alectinib (DRUG).
Who is sponsoring clinical trial NCT05987644?
This trial is sponsored by Joshua Palmer, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05987644 being conducted?
This trial has 3 study locations across California, Colorado, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05987644's enrollment target sits among peer trials
56 255th of 409 higher than 153 of 409 other Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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