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NCT02971501 · ClinicalTrials.gov registry record · Phase 2
Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases
A Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
- 18
- Study locations
NCT02971501: Active Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, sponsored by National Cancer Institute (NCI).
NCT02971501 is a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 7 participants, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (93% lower). The trial reports 18 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02971501, a Phase 2 study of Stage IV Lung Cancer AJCC v8 and Metastatic Malignant Neoplasm in the Brain, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
- 18
- Study locations
Study Summary
This phase II trial studies how well osimertinib with or without bevacizumab works in treating patients with EGFR positive non-small cell lung cancer that has spread to the brain (brain metastases). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab may stop or slow non-small cell lung cancer by blocking the growth of new blood vessels necessary for tumor growth. Giving osimertinib with or without bevacizumab may work better in treating patients with non-small cell lung cancer.
Primary Outcome
The two study arms will be compared for PFS with Kaplan-Meier estimates and log-rank tests. The Rothman confidence interval (CI) will be reported. In addition, the possible risk factors will be compared for survival with log-rank test. For multivariate analysis, the proportional hazards Cox model will be applied to investigate potential prognostic factors, such as age and stage of disease of the PFS data. The adjusted p-values of the hazard ratios and the adjusted 95% confidence interval will be
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Biopsy Procedure
- BIOLOGICAL Bevacizumab
Study Locations (18)
California
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Keck Medical Center of USC Pasadena - Pasadena
- University of California Davis Comprehensive Cancer Center - Sacramento
Nebraska
- Nebraska Medicine-Bellevue - Bellevue
- Nebraska Medicine-Village Pointe - Omaha
- University of Nebraska Medical Center - Omaha
Connecticut
- Smilow Cancer Center/Yale-New Haven Hospital - New Haven
- Yale University - New Haven
Florida
- Moffitt Cancer Center-International Plaza - Tampa
- Moffitt Cancer Center - Tampa
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Hospital-Westwood Cancer Center - Westwood
New York
- NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center - New York
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2018-06-27 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 2 |
What the registry record for NCT02971501 still lists
NCT02971501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 98-participant average among 81 other Stage IV Lung Cancer AJCC v8 trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Stage IV Lung Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02971501 lists 18 locations in 10 states (California, Nebraska, Connecticut).
Frequently Asked Questions
What is clinical trial NCT02971501 about?
NCT02971501 is a clinical study titled "Osimertinib With or Without Bevacizumab in Treating Patients With EGFR Positive Non-small Cell Lung Cancer and Brain Metastases". This phase II trial studies how well osimertinib with or without bevacizumab works in treating patients with EGFR positive non-small cell lung cancer that has spread to the brain (brain metastases). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth...
What is the current status of trial NCT02971501?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2018-06-27. Estimated completion is 2026-07-01.
What conditions does trial NCT02971501 study?
This clinical trial studies the following conditions: Stage IV Lung Cancer AJCC v8, Metastatic Malignant Neoplasm in the Brain, Metastatic Lung Non-Small Cell Carcinoma.
What interventions are being tested in trial NCT02971501?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Biopsy Procedure (PROCEDURE), Bevacizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02971501?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02971501 being conducted?
This trial has 18 study locations across California, Connecticut, Florida, Kansas, Nebraska. 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 NCT02971501's enrollment target sits among peer trials
7 76th of 81 higher than 6 of 81 other Stage IV Lung Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Lung Cancer AJCC v8 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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