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NCT04919369 · ClinicalTrials.gov registry record · Phase 1
All-Trans Retinoic Acid (ATRA) and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer
A Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, sponsored by Dwight Owen.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04919369: Active Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, sponsored by Dwight Owen.
NCT04919369 is a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma that is active but no longer recruiting, run by Dwight Owen. The registered enrollment target is 18 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04919369, a Phase 1 study of Stage IV Lung Cancer AJCC v8 and Metastatic Lung Non-Small Cell Carcinoma, is active but no longer recruiting, sponsored by Dwight Owen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase Ib trial is to find out the best dose and side effects of all-trans retinoic acid (ATRA) and atezolizumab in treating patients with non-small cell lung cancer that has come back (recurrent) or has spread to other places in the body (metastatic). All-trans retinoic acid (ATRA) is made in the body from vitamin A and helps cells to grow and develop. 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. Giving all-trans retinoic acid (ATRA) and atezolizumab may help treat patients with non-small cell lung cancer.
Primary Outcome
Safety will be measured by the occurrence of dose-limited toxicities (DLTs) as well as any other adverse events as defined in Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5. Frequency and severity of AEs and tolerability of the regimen will be collected and summarized by descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. All patients who have received at
Conditions Studied
Interventions
- BIOLOGICAL Atezolizumab
- DRUG Tretinoin
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2021-10-18 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT04919369 still lists
NCT04919369 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 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 (82% lower).
The record links to 5 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Atezolizumab is the first listed.
NCT04919369 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04919369 about?
NCT04919369 is a clinical study titled "All-Trans Retinoic Acid (ATRA) and Atezolizumab for the Treatment of Recurrent or Metastatic Non-Small Cell Lung Cancer". This phase Ib trial is to find out the best dose and side effects of all-trans retinoic acid (ATRA) and atezolizumab in treating patients with non-small cell lung cancer that has come back (recurrent) or has spread to other places in the body (metastatic). All-trans retinoic acid (ATRA) is made in t...
What is the current status of trial NCT04919369?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2021-10-18. Estimated completion is 2026-12-31.
What conditions does trial NCT04919369 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Metastatic Lung Non-Small Cell Carcinoma, Stage IVA Lung Cancer AJCC v8, Stage IVB Lung Cancer AJCC v8, Recurrent Lung Non-Small Cell Carcinoma.
What interventions are being tested in trial NCT04919369?
The interventions under investigation include: Atezolizumab (BIOLOGICAL), Tretinoin (DRUG).
Who is sponsoring clinical trial NCT04919369?
This trial is sponsored by Dwight Owen, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04919369 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04919369's enrollment target sits among peer trials
18 67th of 81 higher than 15 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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