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NCT03148327 · ClinicalTrials.gov registry record · Phase 1
Astra Zeneca (Immuno Stereotactic Ablative Body Radiotherapy) ISABR Study: Randomized Phase I/II Study of Stereotactic Body Radiotherapy
A Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Jonsson Comprehensive Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 4
- Study locations
NCT03148327: Active Phase 1 study of Carcinoma, Non-Small Cell Lung, sponsored by Jonsson Comprehensive Cancer Center.
NCT03148327 is a Phase 1 study of Carcinoma, Non-Small Cell Lung that is active but no longer recruiting, run by Jonsson Comprehensive Cancer Center. The registered enrollment target is 18 participants, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03148327, a Phase 1 study of Carcinoma, Non-Small Cell Lung, is active but no longer recruiting, sponsored by Jonsson Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 4
- Study locations
Study Summary
This study uses durvalumab (MEDI 4736), an experimental type of drug made by Astra Zeneca Pharmaceuticals, (limited partnership) LP, which in early studies has shown to possibly reduce the growth of certain types of lung cancer. The Investigators will enroll up to 105 subjects into the study. After an initial safety sample of 15 individuals receiving durvalumab (MEDI 4736) and Stereotactic Ablative Body Radiotherapy (SABR), if it is shown to be safe to administer this combination of therapies, the next enrolled subjects will be randomized in a 1:1 fashion (each subject with a "50-50 chance" like the flip of a coin) to receive either SABR and durvalumab (MEDI 4736), or SABR alone. Once treatment is completed, all subjects will return to the University of California at Los Angeles (UCLA) for regular follow-up visits to check on their health and outcomes. At visits both prior to and after treatment special blood samples will be drawn to be studied by UCLA scientists to look into the basic science aspects of how durvalumab (MEDI 4736) and radiation work in the body. It is hoped that we will learn more about the basic safety and science of durvalumab (MEDI 4736) combined with Stereotactic Ablative Body Radiotherapy (SABR) vs. SABR alone, while extending the life and quality of life of these subjects.
Primary Outcome
the safety and tolerability associated with radiation therapy and durvalumab (MEDI 4736)
Conditions Studied
Interventions
- RADIATION Radiotherapy
- DRUG Durvalumab (MEDI 4736)
Study Locations (4)
California
- Jonsson Comprehensieve Cancer Center - Los Angeles
Colorado
- University of Colorado - Denver
New York
- New York Weill Cornell Cancer Center at Cornell University - New York
Victoria
- Peter MacCallum Cancer Centre - Melbourne E.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2017-10-11 |
| Est. Completion | 2027-06-01 |
| Phase | Phase 1 |
What the registry record for NCT03148327 still lists
NCT03148327 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 324-participant average among 130 other Carcinoma, Non-Small Cell Lung trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Carcinoma, Non-Small Cell Lung appearing as the primary indexed condition, and to 2 interventions - of which Radiotherapy is the first listed.
NCT03148327 reports a single indexed study location in California, Colorado, New York.
Frequently Asked Questions
What is clinical trial NCT03148327 about?
NCT03148327 is a clinical study titled "Astra Zeneca (Immuno Stereotactic Ablative Body Radiotherapy) ISABR Study: Randomized Phase I/II Study of Stereotactic Body Radiotherapy". This study uses durvalumab (MEDI 4736), an experimental type of drug made by Astra Zeneca Pharmaceuticals, (limited partnership) LP, which in early studies has shown to possibly reduce the growth of certain types of lung cancer. The Investigators will enroll up to 105 subjects into the study. After ...
What is the current status of trial NCT03148327?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2017-10-11. Estimated completion is 2027-06-01.
What conditions does trial NCT03148327 study?
This clinical trial studies the following conditions: Carcinoma, Non-Small Cell Lung.
What interventions are being tested in trial NCT03148327?
The interventions under investigation include: Radiotherapy (RADIATION), Durvalumab (MEDI 4736) (DRUG).
Who is sponsoring clinical trial NCT03148327?
This trial is sponsored by Jonsson Comprehensive Cancer Center, which has 321 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03148327 being conducted?
This trial has 4 study locations across California, Colorado, New York, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03148327's enrollment target sits among peer trials
18 120th of 130 higher than 9 of 130 other Carcinoma, Non-Small Cell Lung trials
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