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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: Completed Phase 2 study of Stage IV Non-small Cell Lung Cancer, sponsored by Case Comprehensive Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Best Overall Response is the best response recorded from the start of the treatment until disease progression (taking as reference for progressive disease the smallest measurements recorded since the treatment started). The anti-tumor activity will be evaluated as an efficacy endpoints based on radiographic (CT or PET/CT). RECIST 1.1 will be applied for evaluation of tumor response. RECIST 1.1 criteria are as follows: Complete Response (CR) is defined as the disappearance of all lesions and
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 |
What the finished NCT02658097 record still lists
NCT02658097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 689-participant average among 23 other Stage IV Non-small Cell Lung Cancer trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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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 NCT02658097's enrollment target sits among peer trials
13 20th of 23 higher than 3 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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