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NCT04728230 · ClinicalTrials.gov registry record · Phase 1
Olaparib and Durvalumab With Carboplatin, Etoposide, and/or Radiation Therapy for the Treatment of Extensive-Stage Small Cell Lung Cancer, PRIO Trial
A Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 63
- Enrollment target
- 1
- Study location
NCT04728230: Active Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT04728230 is a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 63 participants, below the 97-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (35% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04728230, a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Stage IVA Lung Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 63 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trials investigates the side effects of olaparib and durvalumab and how well it works in combination with carboplatin, etoposide, and/or radiation therapy in treating patients with extensive stage-small cell lung cancer (ES-SCLC) who have not received treatment for their disease. PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as carboplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy sources to kill tumor cells and shrink tumors. Giving olaparib and durvalumab together with carboplatin, etoposide, and/or radiation therapy may help treat patients with ES-SCLC.
Primary Outcome
Will be assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. Toxicity data by type and severity will be summarized in frequency tables.
Conditions Studied
Interventions
- DRUG Carboplatin
- BIOLOGICAL Durvalumab
- DRUG Olaparib
- RADIATION Radiation Therapy
- DRUG Etoposide
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2021-01-05 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04728230 still lists
NCT04728230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 97-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (35% lower).
The record links to 4 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT04728230 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04728230 about?
NCT04728230 is a clinical study titled "Olaparib and Durvalumab With Carboplatin, Etoposide, and/or Radiation Therapy for the Treatment of Extensive-Stage Small Cell Lung Cancer, PRIO Trial". This phase I/II trials investigates the side effects of olaparib and durvalumab and how well it works in combination with carboplatin, etoposide, and/or radiation therapy in treating patients with extensive stage-small cell lung cancer (ES-SCLC) who have not received treatment for their disease. PAR...
What is the current status of trial NCT04728230?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 63 participants. The study started on 2021-01-05. Estimated completion is 2027-12-31.
What conditions does trial NCT04728230 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Extensive Stage Lung Small Cell Carcinoma.
What interventions are being tested in trial NCT04728230?
The interventions under investigation include: Carboplatin (DRUG), Durvalumab (BIOLOGICAL), Olaparib (DRUG), Radiation Therapy (RADIATION), Etoposide (DRUG).
Who is sponsoring clinical trial NCT04728230?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04728230 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 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 NCT04728230's enrollment target sits among peer trials
63 28th of 81 higher than 54 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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