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NCT02581943 · ClinicalTrials.gov registry record · Phase 2
Effect of Pembrolizumab With or Without Carboplatin and Paclitaxel on Immune Response in Patients With Recurrent or Stage IIIB-IV Non-small Cell Lung Cancer
A Phase 2 study of Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT02581943: Completed Phase 2 study of Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, sponsored by Wake Forest University Health Sciences.
NCT02581943 is a Phase 2 study of Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 43 participants, below the 688-participant average among 23 other Stage IV Non-small Cell Lung Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02581943, a Phase 2 study of Stage IV Non-small Cell Lung Cancer and Stage IIIB Non-small Cell Lung Cancer, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
This randomized pilot phase II trial studies the effect of pembrolizumab with or without carboplatin and paclitaxel on immune response in patients with non-small cell lung cancer that has come back or stage IIIB-IV. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, 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 pembrolizumab together with carboplatin and paclitaxel may improve immune responses in patients with non-small cell lung cancer.
Primary Outcome
Duration of response will also be assessed in each group and compared using survival analysis methods. Per response evaluation criteria in Solid Tumors Criteria: Complete Response (irCR): Complete disappearance of all target and new, measurable lesions, with the exceptions of lymph nodes which must decrease to \< 10 mm in short axis; Partial Response (irPR): Decrease in TMTB ≥ 30% relative to baseline; Stable Disease (irSD): Not meeting criteria for irCR or irPR, in absence of irPD; Progressive
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- DRUG Carboplatin
- OTHER Quality-of-Life Assessment
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2016-06-17 |
| Est. Completion | 2022-12-28 |
| Phase | Phase 2 |
What the finished NCT02581943 record still lists
NCT02581943 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 688-participant average among 23 other Stage IV Non-small Cell Lung Cancer trials with a reported enrollment target (94% lower).
The record links to 3 conditions, with Stage IV Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT02581943 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02581943 about?
NCT02581943 is a clinical study titled "Effect of Pembrolizumab With or Without Carboplatin and Paclitaxel on Immune Response in Patients With Recurrent or Stage IIIB-IV Non-small Cell Lung Cancer". This randomized pilot phase II trial studies the effect of pembrolizumab with or without carboplatin and paclitaxel on immune response in patients with non-small cell lung cancer that has come back or stage IIIB-IV. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumo...
What is the current status of trial NCT02581943?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2016-06-17. Estimated completion is 2022-12-28.
What conditions does trial NCT02581943 study?
This clinical trial studies the following conditions: Stage IV Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Recurrent Non-Small Cell Lung Carcinoma.
What interventions are being tested in trial NCT02581943?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Carboplatin (DRUG), Quality-of-Life Assessment (OTHER), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT02581943?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02581943 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02581943's enrollment target sits among peer trials
43 15th of 23 higher than 9 of 23 other Stage IV Non-small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV 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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