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NCT03662074 · ClinicalTrials.gov registry record · Phase 2
Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 14
- Enrollment target
NCT03662074: Clinical Trial Phase 2 study, sponsored by Wake Forest University Health Sciences.
NCT03662074 is a Phase 2 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 14 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03662074, a Phase 2 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 14 participants
- Enrollment target
Study Summary
This phase II pilot trial studies how well gemcitabine and nivolumab work in treating participants with small cell lung cancer that has spread to other parts of the body after other treatments have failed. Drugs used in chemotherapy, such as gemcitabine, 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. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Giving second-line gemcitabine and nivolumab may work better in treating participants with small cell lung cancer.
Primary Outcome
Objective RR (complete response \[CR\] + partial response \[PR\]) will be compared between this study sample and a historical benchmark value of 10%. For this comparison we will use a one-sample test of proportion. * Complete Response (CR): Disappearance of all target lesions. * Partial Response (PR): Decrease by ≥ 30% in sum of longest diameter of target lesions. * Stable Disease (SD): Not meeting criteria for CR, PR, or PD. * Progressive Disease (PD): Increase by ≥ 20% in sum of longest diame
Interventions
- DRUG Gemcitabine
- BIOLOGICAL Nivolumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2018-11-07 |
| Est. Completion | 2022-02-03 |
| Phase | Phase 2 |
Why NCT03662074 stopped before completion
NCT03662074 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 2 interventions - of which Gemcitabine is the first listed.
NCT03662074 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03662074 about?
NCT03662074 is a clinical study titled "Subsequent Line Gemcitabine and Nivolumab in Treating Participants With Metastatic Small Cell Lung Cancer". This phase II pilot trial studies how well gemcitabine and nivolumab work in treating participants with small cell lung cancer that has spread to other parts of the body after other treatments have failed. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of ...
What is the current status of trial NCT03662074?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 14 participants. The study started on 2018-11-07. Estimated completion is 2022-02-03.
What interventions are being tested in trial NCT03662074?
The interventions under investigation include: Gemcitabine (DRUG), Nivolumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03662074?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03662074's enrollment target sits among peer trials
14 1941st of 2000 higher than 54 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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