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NCT04505267 · ClinicalTrials.gov registry record · Phase 1
NBTXR3 and Radiation Therapy for the Treatment of Inoperable Recurrent Non-small Cell Lung Cancer
A Phase 1 study of Stage III Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT04505267: Active Phase 1 study of Stage III Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT04505267 is a Phase 1 study of Stage III Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 34 participants, below the 99-participant average among 40 other Stage III Lung Cancer AJCC v8 trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04505267, a Phase 1 study of Stage III Lung Cancer AJCC v8 and Recurrent Lung Non-Small Cell Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial investigates the best dose and side effects of NBTXR3 when given together with radiation therapy for the treatment of non-small cell lung cancer that cannot be treated by surgery (inoperable) and has come back (recurrent). NBTXR3 is a radio-enhancer designed to increase the radiotherapy energy dose deposition inside tumor cells. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving NBTXR3 and radiation therapy may increase radiation-dependent tumor cell killing without increasing the radiation exposure of healthy surrounding tissues.
Primary Outcome
Defined as the occurrence and frequency of DLTs by dose level of NBTXR3. Descriptive summary tables will be produced, providing the DLTs by initial planned dose level of NBTXR3, initial planned volume of NBTXR3 to be injected, the injected volume and the RT dose given.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- OTHER Hafnium Oxide-containing Nanoparticles NBTXR3
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2021-02-10 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What the registry record for NCT04505267 still lists
NCT04505267 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 99-participant average among 40 other Stage III Lung Cancer AJCC v8 trials with a reported enrollment target (66% lower).
The record links to 10 conditions, with Stage III Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Radiation Therapy is the first listed.
NCT04505267 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04505267 about?
NCT04505267 is a clinical study titled "NBTXR3 and Radiation Therapy for the Treatment of Inoperable Recurrent Non-small Cell Lung Cancer". This phase I trial investigates the best dose and side effects of NBTXR3 when given together with radiation therapy for the treatment of non-small cell lung cancer that cannot be treated by surgery (inoperable) and has come back (recurrent). NBTXR3 is a radio-enhancer designed to increase the radiot...
What is the current status of trial NCT04505267?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2021-02-10. Estimated completion is 2026-03-31.
What conditions does trial NCT04505267 study?
This clinical trial studies the following conditions: Stage III Lung Cancer AJCC v8, Recurrent Lung Non-Small Cell Carcinoma, Stage II Lung Cancer AJCC v8, Stage I Lung Cancer AJCC v8, Stage IIA Lung Cancer AJCC v8.
What interventions are being tested in trial NCT04505267?
The interventions under investigation include: Radiation Therapy (RADIATION), Hafnium Oxide-containing Nanoparticles NBTXR3 (OTHER).
Who is sponsoring clinical trial NCT04505267?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04505267 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage III Lung Cancer AJCC v8
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 NCT04505267's enrollment target sits among peer trials
34 28th of 40 higher than 12 of 40 other Stage III Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III 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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