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NCT03663166 · ClinicalTrials.gov registry record · Phase 1
Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)
A Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT03663166: Clinical Trial Phase 1 study, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT03663166 is a Phase 1 study that was terminated before completion, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03663166, a Phase 1 study, was terminated before completion, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
This study is to determine if Stage III NSCLC patients treated with ipilimumab with thoracic radiation therapy followed by nivolumab monotherapy every 4 weeks for up to 12 months show an improved 12-month Progression Free Survival (PFS) rate compared with a 12-month historical PFS rate of 49% among patients treated in a similar fashion with concurrent chemoradiotherapy.
Primary Outcome
Unacceptable toxicity defined as: * Any grade 4 immune related adverse event (irAE) * Any grade 3 irAE, excluding pneumonitis, that does not downgrade to grade 2 within 7 days after onset of the event despite optimal medical management including systemic corticosteroids or does not downgrade to ≤ grade 1 or baseline within 14 days * Liver transaminase elevation \> 8 × ULN or total bilirubin \> 5 × ULN, * Any ≥ grade 3 non-irAE, with some exclusions. Result is provided as number of participants
Interventions
- DRUG Nivolumab
- RADIATION Thoracic Radiotherapy
- DRUG ipilimumab
- DRUG Platinum Based Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2018-11-20 |
| Est. Completion | 2021-10-22 |
| Phase | Phase 1 |
Why NCT03663166 stopped before completion
NCT03663166 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 4 interventions - of which Nivolumab is the first listed.
NCT03663166 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03663166 about?
NCT03663166 is a clinical study titled "Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)". This study is to determine if Stage III NSCLC patients treated with ipilimumab with thoracic radiation therapy followed by nivolumab monotherapy every 4 weeks for up to 12 months show an improved 12-month Progression Free Survival (PFS) rate compared with a 12-month historical PFS rate of 49% among ...
What is the current status of trial NCT03663166?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2018-11-20. Estimated completion is 2021-10-22.
What interventions are being tested in trial NCT03663166?
The interventions under investigation include: Nivolumab (DRUG), Thoracic Radiotherapy (RADIATION), ipilimumab (DRUG), Platinum Based Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT03663166?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03663166's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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