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NCT03916419 · ClinicalTrials.gov registry record · Phase 2
Magnetic Resonance-Guided Hypofractionated Adaptive Radiation Therapy With Concurrent Chemotherapy and Consolidation Durvalumab for Inoperable Stage IIB, IIIA, and Select IIIB and IIIC Non-small Cell Lung Cancer
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT03916419: Completed Phase 2 study, sponsored by Washington University School of Medicine.
NCT03916419 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03916419, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
Building upon the clinical experience of the investigators with the magnetic resonance (MR)-guided radiation therapy system and applying principals of hypofractionation toward the current treatment paradigm of concurrent chemoradiation and consolidation immunotherapy for locally advanced non-small cell lung cancer (NSCLC), this prospective, single-arm Phase II clinical trial with safety lead-in will test the feasibility and outcomes of this approach.
Primary Outcome
* Safety of hypofractionated MRI-guided adaptive radiotherapy (60Gy/15 fractions) with concurrent chemotherapy (carboplatin and paclitaxel) and consolidation durvalumab is defined as \<2/6 participants experiencing dose limiting toxicities * DLT is defined as any possibly, probably, or definitely related to concurrent chemoradiation grade 3 toxicity that cannot be managed with maximal supportive care within 2 weeks, or any grade \> 4 toxicity that occurs during treatment * The descriptions and g
Interventions
- BIOLOGICAL Durvalumab
- DRUG Paclitaxel
- RADIATION Radiation therapy
- DRUG Carboplatin AUC
- DEVICE ViewRay MR-Linear Accelerator
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2019-06-20 |
| Est. Completion | 2025-09-28 |
| Phase | Phase 2 |
What the finished NCT03916419 record still lists
NCT03916419 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 5 interventions - of which Durvalumab is the first listed.
NCT03916419 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03916419 about?
NCT03916419 is a clinical study titled "Magnetic Resonance-Guided Hypofractionated Adaptive Radiation Therapy With Concurrent Chemotherapy and Consolidation Durvalumab for Inoperable Stage IIB, IIIA, and Select IIIB and IIIC Non-small Cell Lung Cancer". Building upon the clinical experience of the investigators with the magnetic resonance (MR)-guided radiation therapy system and applying principals of hypofractionation toward the current treatment paradigm of concurrent chemoradiation and consolidation immunotherapy for locally advanced non-small c...
What is the current status of trial NCT03916419?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2019-06-20. Estimated completion is 2025-09-28.
What interventions are being tested in trial NCT03916419?
The interventions under investigation include: Durvalumab (BIOLOGICAL), Paclitaxel (DRUG), Radiation therapy (RADIATION), Carboplatin AUC (DRUG), ViewRay MR-Linear Accelerator (DEVICE).
Who is sponsoring clinical trial NCT03916419?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03916419's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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