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NCT03728361 · ClinicalTrials.gov registry record · Phase 2
Nivolumab and Temozolomide in Treating Patients With Recurrent or Refractory Small-Cell Lung Cancer or Advanced Neuroendocrine Cancer
A Phase 2 study of Neuroendocrine Tumors and Neuroendocrine Carcinoma, sponsored by Dwight Owen.
- Active
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
- 2
- Study locations
NCT03728361: Active Phase 2 study of Neuroendocrine Tumors and Neuroendocrine Carcinoma, sponsored by Dwight Owen.
NCT03728361 is a Phase 2 study of Neuroendocrine Tumors and Neuroendocrine Carcinoma that is active but no longer recruiting, run by Dwight Owen. The registered enrollment target is 55 participants, below the 179-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (69% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03728361, a Phase 2 study of Neuroendocrine Tumors and Neuroendocrine Carcinoma, is active but no longer recruiting, sponsored by Dwight Owen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies how well nivolumab and temozolomide work in treating patients with small-cell lung cancer that has come back or does not respond to treatment, or neuroendocrine cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as temozolomide, 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. Giving nivolumab and temozolomide may work better in treating patients with small-cell lung cancer and neuroendocrine cancer.
Primary Outcome
Response will be defined by a complete response (CR) or partial response (PR), confirmed or unconfirmed. Response will be defined for patients with measurable disease and who receive at least one dose of combination treatment. Exact binomial 95% confidence intervals for the true PR+CR response rate will be calculated.
Conditions Studied
Interventions
- DRUG Temozolomide
- BIOLOGICAL Nivolumab
Study Locations (2)
Ohio
- Ohio State University Comprehensive Cancer Center-COHORT 1 - Columbus
- Ohio State University Comprehensive Cancer Center-COHORT 2 - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2018-12-31 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
What the registry record for NCT03728361 still lists
NCT03728361 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 179-participant average among 52 other Neuroendocrine Tumors trials with a reported enrollment target (69% lower).
The record links to 10 conditions, with Neuroendocrine Tumors appearing as the primary indexed condition, and to 2 interventions - of which Temozolomide is the first listed.
NCT03728361 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT03728361 about?
NCT03728361 is a clinical study titled "Nivolumab and Temozolomide in Treating Patients With Recurrent or Refractory Small-Cell Lung Cancer or Advanced Neuroendocrine Cancer". This phase II trial studies how well nivolumab and temozolomide work in treating patients with small-cell lung cancer that has come back or does not respond to treatment, or neuroendocrine cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as nivolumab...
What is the current status of trial NCT03728361?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2018-12-31. Estimated completion is 2026-10-31.
What conditions does trial NCT03728361 study?
This clinical trial studies the following conditions: Neuroendocrine Tumors, Neuroendocrine Carcinoma, Large Cell Neuroendocrine Carcinoma, Metastatic Neuroendocrine Carcinoma, Recurrent Small Cell Lung Carcinoma.
What interventions are being tested in trial NCT03728361?
The interventions under investigation include: Temozolomide (DRUG), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03728361?
This trial is sponsored by Dwight Owen, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03728361 being conducted?
This trial has 2 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03728361's enrollment target sits among peer trials
55 30th of 52 higher than 23 of 52 other Neuroendocrine Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neuroendocrine Tumors 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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