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NCT03377023 · ClinicalTrials.gov registry record · Phase 1
Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer
A Phase 1 study of Non-Small Cell Lung Cancer and Non Small Cell Lung Cancer Metastatic, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 1
- Study location
NCT03377023: Active Phase 1 study of Non-Small Cell Lung Cancer and Non Small Cell Lung Cancer Metastatic, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03377023 is a Phase 1 study of Non-Small Cell Lung Cancer and Non Small Cell Lung Cancer Metastatic that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 66 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03377023, a Phase 1 study of Non-Small Cell Lung Cancer and Non Small Cell Lung Cancer Metastatic, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this study is to see if the combination of nivolumab, ipilimumab and nintedanib is effective in people with non- small cell lung cancer. Researchers also want to find out if the combination of nivolumab, ipilimumab and nintedanib is safe and tolerable.
Primary Outcome
Dose escalation to determine the MTD and Recommended Phase 2 Dose (RP2D) of concurrent administration of nivolumab, ipilimumab, and nintedanib. The maximum tolerated dose (MTD) is defined as the dose with the dose limiting toxicity (DLT) rate of 30%. Phase 1 began with 100 mg nintedanib, 3 mg/kg IV nivolumab + 1 mg/kg ipilimumab. Dosing of nintedanib increased by 50 mg in each level until dose limiting toxicity.
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Nintedanib
Study Locations (1)
Florida
- H. Lee Moffitt Cancer Center and Research Institute - Tampa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2018-02-02 |
| Est. Completion | 2026-08 |
| Phase | Phase 1 |
What the registry record for NCT03377023 still lists
NCT03377023 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (90% lower).
The record links to 3 conditions, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT03377023 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT03377023 about?
NCT03377023 is a clinical study titled "Phase I/II Study of Nivolumab and Ipilimumab Combined With Nintedanib in Non Small Cell Lung Cancer". The main purpose of this study is to see if the combination of nivolumab, ipilimumab and nintedanib is effective in people with non- small cell lung cancer. Researchers also want to find out if the combination of nivolumab, ipilimumab and nintedanib is safe and tolerable.
What is the current status of trial NCT03377023?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2018-02-02. Estimated completion is 2026-08.
What conditions does trial NCT03377023 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer, Non Small Cell Lung Cancer Metastatic, Lung Cancer, Non-Small Cell.
What interventions are being tested in trial NCT03377023?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Nintedanib (DRUG).
Who is sponsoring clinical trial NCT03377023?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03377023 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03377023's enrollment target sits among peer trials
66 301st of 454 higher than 151 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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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