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NCT06814496 · ClinicalTrials.gov registry record · Phase 1
Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors
A Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, sponsored by University of Arizona.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06814496 is a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma that is actively recruiting participants, run by University of Arizona. The registered enrollment target is 30 participants, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06814496, a Phase 1 study of Non-Small Cell Lung Cancer and Melanoma, is actively recruiting participants, sponsored by University of Arizona.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
Phase I study to examine safety of the addition of concurrent tarlatamab with standard palliative and consolidative RT regimens , with a main cohort of N=20-24 patients with extracranial anatomic radiation sites. I) After lead in of 10 patients demonstrating safety of treatment, allow for expansion to cranial sites of disease (N=6-10) with continued enrollment in main cohort II) If toxicity criteria is not met in concurrent RT tarlatamab cohort, we will continue with sequential RT, either A) delivered within 7 days prior to cycle 1 day 1, or B) delivered during cycle 1 -2 but with pre- and post-RT washout of 7 days with no drug during RT, to examine safety in a temporally spaced setting. III) If sequential tarlatamab and radiation is not deemed safe, we would allow for continued enrollment to assess efficacy of drug sans radiation treatment, enriching for tumors not of small cell lung cancer histology and allowing for patients without sites amenable to RT. A nested phase II study will attempt to assess for ORR and safety of study intervention amongst tumors not of small cell lung cancer histology.
Conditions Studied
Interventions
- DRUG Tarlatamab
- RADIATION Concurrent Radiation Therapy
- RADIATION Sequential Radiation therapy
Study Locations (1)
Arizona
- Arizona Cancer Center at UMC North/University Medical Center - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-09-08 |
| Est. Completion | 2030-05 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06814496
The ClinicalTrials.gov registry entry for NCT06814496 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 659-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (95% lower). The listed sponsor is University of Arizona, which has 349 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Tarlatamab is the first listed.
NCT06814496 reports 1 study location spanning 1 distinct geographic area - top geographies include Arizona.
Frequently Asked Questions
What is clinical trial NCT06814496 about?
NCT06814496 is a clinical study titled "Radiation Combined With BIspecific T-Cell Engager in DLL3 Expressing Tumors". Phase I study to examine safety of the addition of concurrent tarlatamab with standard palliative and consolidative RT regimens , with a main cohort of N=20-24 patients with extracranial anatomic radiation sites. I) After lead in of 10 patients demonstrating safety of treatment, allow for expansion...
What is the current status of trial NCT06814496?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2025-09-08. Estimated completion is 2030-05.
What conditions does trial NCT06814496 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Melanoma, Bladder Cancer, Cervical Cancer, Glioblastoma Multiforme.
What interventions are being tested in trial NCT06814496?
The interventions under investigation include: Tarlatamab (DRUG), Concurrent Radiation Therapy (RADIATION), Sequential Radiation therapy (RADIATION).
Who is sponsoring clinical trial NCT06814496?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06814496 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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