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NCT03867175 · ClinicalTrials.gov registry record · Phase 3
Immunotherapy With or Without SBRT in Patients With Stage IV Non-small Cell Lung Cancer
A Phase 3 study of Metastatic Lung Cancer and Stage IV Lung Cancer, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT03867175: Completed Phase 3 study of Metastatic Lung Cancer and Stage IV Lung Cancer, sponsored by Wake Forest University Health Sciences.
NCT03867175 is a Phase 3 study of Metastatic Lung Cancer and Stage IV Lung Cancer that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 5 participants, below the 175-participant average among 10 other Metastatic Lung Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03867175, a Phase 3 study of Metastatic Lung Cancer and Stage IV Lung Cancer, has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase III trial studies immunotherapy and stereotactic body radiation therapy to see how well it works compared with immunotherapy alone after first-line systemic therapy (therapy that goes throughout the body) in treating patients with stage IV non-small cell lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. Giving immunotherapy with stereotactic body radiation therapy may work better than immunotherapy alone in treating patients with non-small cell lung cancer.
Primary Outcome
Will be determined using the product-limit method of Kaplan and Meier. Will compare unadjusted median PFS between the 2 arms using a log-rank test. Will also use a proportional hazards model to compare progression-free survival between the two groups, adjusting for key covariates such as age, performance (Eastern Cooperative Oncology Group) status, response to initial systemic therapy versus (vs) stable disease, the presence or absence of brain metastases, PD-L1 \[programmed death-ligand \] expr
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- RADIATION Stereotactic Body Radiation Therapy
Study Locations (1)
North Carolina
- Wake Forest Baptist Comprehensive Cancer Center - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2019-06-24 |
| Est. Completion | 2025-04-21 |
| Phase | Phase 3 |
What the finished NCT03867175 record still lists
NCT03867175 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 175-participant average among 10 other Metastatic Lung Cancer trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Metastatic Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT03867175 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03867175 about?
NCT03867175 is a clinical study titled "Immunotherapy With or Without SBRT in Patients With Stage IV Non-small Cell Lung Cancer". This phase III trial studies immunotherapy and stereotactic body radiation therapy to see how well it works compared with immunotherapy alone after first-line systemic therapy (therapy that goes throughout the body) in treating patients with stage IV non-small cell lung cancer. Immunotherapy with mo...
What is the current status of trial NCT03867175?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 5 participants. The study started on 2019-06-24. Estimated completion is 2025-04-21.
What conditions does trial NCT03867175 study?
This clinical trial studies the following conditions: Metastatic Lung Cancer, Stage IV Lung Cancer.
What interventions are being tested in trial NCT03867175?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Stereotactic Body Radiation Therapy (RADIATION).
Who is sponsoring clinical trial NCT03867175?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03867175 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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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 NCT03867175's enrollment target sits among peer trials
5 11th of 10 the lowest of 10 other Metastatic Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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