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NCT06110572 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation
A Phase 1 study of Extensive Stage Lung Small Cell Carcinoma and Stage IV Lung Cancer, sponsored by Vanderbilt-Ingram Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT06110572 is a Phase 1 study of Extensive Stage Lung Small Cell Carcinoma and Stage IV Lung Cancer that is actively recruiting participants, run by Vanderbilt-Ingram Cancer Center. The registered enrollment target is 18 participants, below the 151-participant average among 16 other Extensive Stage Lung Small Cell Carcinoma trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06110572, a Phase 1 study of Extensive Stage Lung Small Cell Carcinoma and Stage IV Lung Cancer, is actively recruiting participants, sponsored by Vanderbilt-Ingram Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects, safety, and effectiveness of low dose radiation to the entire body (total body irradiation \[TBI\]) and higher dose radiation to known areas of cancer (hypofractionated radiation therapy \[H-RT\]) combined with atezolizumab and chemotherapy (carboplatin \& etoposide) in treating patients with small cell lung cancer that has spread to disease sites outside of the lung (extensive stage). Extensive stage disease has historically been treated with chemotherapy alone with consideration of chest (thoracic) radiation therapy for those with response to chemotherapy, as well as consideration of preventative radiation therapy to the head (prophylactic cranial irradiation). Emerging evidence supports the synergistic interactions between immunotherapy and radiation therapy. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Combining TBI and H-RT with atezolizumab and chemotherapy may improve response to treatment.
Conditions Studied
Interventions
- DRUG Carboplatin
- BIOLOGICAL Atezolizumab
- DRUG Etoposide
- RADIATION Hypofractionated Radiation Therapy
- RADIATION Total Body Irradiation
Study Locations (1)
Tennessee
- Vanderbilt University/Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2024-04-24 |
| Est. Completion | 2028-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06110572
The ClinicalTrials.gov registry entry for NCT06110572 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 151-participant average among 16 other Extensive Stage Lung Small Cell Carcinoma trials with a reported enrollment target (88% lower). The listed sponsor is Vanderbilt-Ingram Cancer Center, which has 189 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Extensive Stage Lung Small Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT06110572 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT06110572 about?
NCT06110572 is a clinical study titled "Phase I/II Trial in ES-SCLC to Enhance Response to Atezolizumab Plus Chemotherapy With Total Body Irradiation". This phase I/II trial studies the side effects, safety, and effectiveness of low dose radiation to the entire body (total body irradiation \[TBI\]) and higher dose radiation to known areas of cancer (hypofractionated radiation therapy \[H-RT\]) combined with atezolizumab and chemotherapy (carboplati...
What is the current status of trial NCT06110572?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2024-04-24. Estimated completion is 2028-06-30.
What conditions does trial NCT06110572 study?
This clinical trial studies the following conditions: Extensive Stage Lung Small Cell Carcinoma, Stage IV Lung Cancer.
What interventions are being tested in trial NCT06110572?
The interventions under investigation include: Carboplatin (DRUG), Atezolizumab (BIOLOGICAL), Etoposide (DRUG), Hypofractionated Radiation Therapy (RADIATION), Total Body Irradiation (RADIATION).
Who is sponsoring clinical trial NCT06110572?
This trial is sponsored by Vanderbilt-Ingram Cancer Center, which has 189 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06110572 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Extensive Stage Lung Small Cell Carcinoma
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Stage IV Lung Cancer
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