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NCT02621398 · ClinicalTrials.gov registry record · Phase 1
Pembrolizumab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Stage II-IIIB Non-Small Cell Lung Cancer
A Phase 1 study of Stage IIIB Non-small Cell Lung Cancer and Stage IIIA Non-Small Cell Lung Cancer, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 3
- Study locations
NCT02621398: Completed Phase 1 study of Stage IIIB Non-small Cell Lung Cancer and Stage IIIA Non-Small Cell Lung Cancer, sponsored by Rutgers, The State University of New Jersey.
NCT02621398 is a Phase 1 study of Stage IIIB Non-small Cell Lung Cancer and Stage IIIA Non-Small Cell Lung Cancer that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 23 participants, below the 47-participant average among 16 other Stage IIIB Non-small Cell Lung Cancer trials with a reported enrollment target (51% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02621398, a Phase 1 study of Stage IIIB Non-small Cell Lung Cancer and Stage IIIA Non-Small Cell Lung Cancer, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase I trial studies the side effects, best dose, and best way to give pembrolizumab when given together with paclitaxel, carboplatin, and radiation therapy in treating patients with stage II-IIIB non-small cell lung cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as paclitaxel and carboplatin, 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving pembrolizumab together with paclitaxel, carboplatin, and radiation therapy may kill more tumor cells.
Primary Outcome
The 3+3 algorithm design will be used to find the MTD. Safety will be evaluated by DLT, defined as grade 4 pneumonitis. Toxicities will be characterized based on seriousness, causality, toxicity grading, and action taken with regard to trial treatment.
Conditions Studied
Interventions
- DRUG Carboplatin
- OTHER Laboratory Biomarker Analysis
- DRUG Paclitaxel
- RADIATION Intensity-Modulated Radiation Therapy
- RADIATION 3-Dimensional Conformal Radiation Therapy
Study Locations (3)
Connecticut
- Yale Cancer Center - New Haven
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Pennsylvania
- University of Pennsylvania/Abramson Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2016-08-04 |
| Est. Completion | 2024-02-29 |
| Phase | Phase 1 |
What the finished NCT02621398 record still lists
NCT02621398 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 47-participant average among 16 other Stage IIIB Non-small Cell Lung Cancer trials with a reported enrollment target (51% lower).
The record links to 3 conditions, with Stage IIIB Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.
NCT02621398 reports a single indexed study location in Connecticut, New Jersey, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02621398 about?
NCT02621398 is a clinical study titled "Pembrolizumab, Paclitaxel, Carboplatin, and Radiation Therapy in Treating Patients With Stage II-IIIB Non-Small Cell Lung Cancer". This phase I trial studies the side effects, best dose, and best way to give pembrolizumab when given together with paclitaxel, carboplatin, and radiation therapy in treating patients with stage II-IIIB non-small cell lung cancer. Monoclonal antibodies, such as pembrolizumab, may interfere with the ...
What is the current status of trial NCT02621398?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2016-08-04. Estimated completion is 2024-02-29.
What conditions does trial NCT02621398 study?
This clinical trial studies the following conditions: Stage IIIB Non-small Cell Lung Cancer, Stage IIIA Non-Small Cell Lung Cancer, Stage II Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT02621398?
The interventions under investigation include: Carboplatin (DRUG), Laboratory Biomarker Analysis (OTHER), Paclitaxel (DRUG), Intensity-Modulated Radiation Therapy (RADIATION), 3-Dimensional Conformal Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT02621398?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02621398 being conducted?
This trial has 3 study locations across Connecticut, New Jersey, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IIIB Non-small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02621398's enrollment target sits among peer trials
23 13th of 16 higher than 4 of 16 other Stage IIIB Non-small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IIIB 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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