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NCT02658097 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab Alone or Sequentially Following Single Fraction Non-ablative Radiation to One of the Target Lesions, in Previously Treated Patients With Stage IV NSCLC
A Phase 2 study of Stage IV Non-small Cell Lung Cancer, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT02658097 is a Phase 2 study of Stage IV Non-small Cell Lung Cancer that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 13 participants, below the 689-participant average among 23 other Stage IV Non-small Cell Lung Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02658097, a Phase 2 study of Stage IV Non-small Cell Lung Cancer, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to determine if low single palliative dose radiation to the lung cancer will improve your immune response against the tumor and if sequential treatment with pembrolizumab (the study drug) would offer superior results compared to pembrolizumab alone in participants with non-small cell lung cancer. The purpose of this research is also to study whether there are any changes present in the DNA, RNA, and proteins of a participant's tumor or the blood cells that may contribute to a response to the study treatment or progression of cancer. This research may help researchers in the future to learn more about the causes, risks, treatments, or prevention of cancers or other health problems. Participants will consent to a screening period, a core or treatment phase, and a post-study observation phase. During the screening phase, participants will undergo a series of tests to determine if they are eligible for the study. The core study period, or treatment period, will start with a single dose of radiation and then continue for the first eight treatments of pembrolizumab, approximately 24-28 weeks. Participants will have a new biopsy taken after two treatments of the study drug. Following the 24-28 week treatment cycle, if the cancer is responding to treatment, the participant's physician will continue to treat with pembrolizumab as a standard treatment. Following treatment, the post-study observation phase will monitor participant response to drugs and outcomes.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- RADIATION Single Fraction Radiation Therapy
Study Locations (1)
Ohio
- Cleveland Clinic, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-06-07 |
| Est. Completion | 2023-03-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02658097
The ClinicalTrials.gov registry entry for NCT02658097 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 689-participant average among 23 other Stage IV Non-small Cell Lung Cancer trials with a reported enrollment target (98% lower). The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Stage IV Non-small Cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02658097 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT02658097 about?
NCT02658097 is a clinical study titled "Pembrolizumab Alone or Sequentially Following Single Fraction Non-ablative Radiation to One of the Target Lesions, in Previously Treated Patients With Stage IV NSCLC". The goal of this clinical trial is to determine if low single palliative dose radiation to the lung cancer will improve your immune response against the tumor and if sequential treatment with pembrolizumab (the study drug) would offer superior results compared to pembrolizumab alone in participants ...
What is the current status of trial NCT02658097?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2017-06-07. Estimated completion is 2023-03-10.
What conditions does trial NCT02658097 study?
This clinical trial studies the following conditions: Stage IV Non-small Cell Lung Cancer.
What interventions are being tested in trial NCT02658097?
The interventions under investigation include: Pembrolizumab (DRUG), Single Fraction Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT02658097?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02658097 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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