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NCT05244239 · ClinicalTrials.gov registry record · Phase 1
Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer
A Phase 1 study of Stage IV Lung Cancer AJCC v8 and Extensive Stage Lung Small Cell Carcinoma, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
- 3
- Study locations
NCT05244239: Recruiting Phase 1 study of Stage IV Lung Cancer AJCC v8 and Extensive Stage Lung Small Cell Carcinoma, sponsored by Emory University.
NCT05244239 is a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Extensive Stage Lung Small Cell Carcinoma that is actively recruiting participants, run by Emory University. The registered enrollment target is 22 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05244239, a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Extensive Stage Lung Small Cell Carcinoma, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I trial aims to determine if it is safe to use palliative radiotherapy and lurbinectedin at the same time to treat small cell lung cancer that has spread outside of the chest and that has grown after being treated with chemotherapy (extensive stage). Lurbinectedin kills tumor cells by blocks a process called transcription that small cell lung cancer relies on to survive. It also damages the deoxyribonucleic acid (DNA) of tumor cells, which is similar to the way radiation kills tumor cells. Palliative radiotherapy is a routine medical treatment for patients who have lung cancer that has spread to other parts of the body (metastatic), and is used to relieve symptoms caused by cancer or to patients from developing symptoms. This trial may help doctors understand if treating patients with lurbinectedin and palliative radiotherapy at the same time would make them both work better than either one alone or if they could cause more side effects for patients when given together.
Primary Outcome
Will be defined as having one or none of the following: * Grade 4 or 5 serious adverse events possibly, probably, or definitely related to protocol treatment from 30 days from the start of RT. * Any adverse events possibly, probably, or definitely related to protocol treatment that leads to prolonged dose delays (defined as with-holding of two consecutive doses of lurbinectedin). * Any adverse event possibly, probably, or definitely related to treatment resulting in the permanent discontinuatio
Conditions Studied
Interventions
- RADIATION Palliative Radiation Therapy
- DRUG Lurbinectedin
Study Locations (3)
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2022-07-27 |
| Est. Completion | 2027-07-28 |
| Phase | Phase 1 |
What NCT05244239 shows while recruiting
NCT05244239 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (78% lower).
The record links to 2 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Palliative Radiation Therapy is the first listed.
NCT05244239 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05244239 about?
NCT05244239 is a clinical study titled "Palliative Radiotherapy With Lurbinectedin in Patients With Extensive Stage Small Cell Lung Cancer". This phase I trial aims to determine if it is safe to use palliative radiotherapy and lurbinectedin at the same time to treat small cell lung cancer that has spread outside of the chest and that has grown after being treated with chemotherapy (extensive stage). Lurbinectedin kills tumor cells by blo...
What is the current status of trial NCT05244239?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2022-07-27. Estimated completion is 2027-07-28.
What conditions does trial NCT05244239 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Extensive Stage Lung Small Cell Carcinoma.
What interventions are being tested in trial NCT05244239?
The interventions under investigation include: Palliative Radiation Therapy (RADIATION), Lurbinectedin (DRUG).
Who is sponsoring clinical trial NCT05244239?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05244239 being conducted?
This trial has 3 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV 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 NCT05244239's enrollment target sits among peer trials
22 61st of 81 higher than 18 of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV 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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