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NCT03191149 · ClinicalTrials.gov registry record · Phase 2
Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change
A Phase 2 study of Recurrent Lung Non-Small Cell Carcinoma and Advanced Lung Non-Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 20
- Study locations
NCT03191149: Recruiting Phase 2 study of Recurrent Lung Non-Small Cell Carcinoma and Advanced Lung Non-Small Cell Carcinoma, sponsored by National Cancer Institute (NCI).
NCT03191149 is a Phase 2 study of Recurrent Lung Non-Small Cell Carcinoma and Advanced Lung Non-Small Cell Carcinoma that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 46 participants, below the 118-participant average among 30 other Recurrent Lung Non-Small Cell Carcinoma trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03191149, a Phase 2 study of Recurrent Lung Non-Small Cell Carcinoma and Advanced Lung Non-Small Cell Carcinoma, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Will be evaluated via Response Evaluation Criteria in Solid Tumors 1.1 criteria. Categorical data, such as response rates (complete response + partial response), will be compared using Fisher's exact tests with a one-sided type I error rate of 10%; multivariable logistic regression modeling will be used to adjust for the effect of any covariates that are associated with these categorical outcomes. Any continuous outcomes will be analyzed using Wilcoxon rank sum test, and multivariable linear reg
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Magnetic Resonance Imaging
- PROCEDURE Echocardiography Test
- PROCEDURE Multigated Acquisition Scan
- PROCEDURE Computed Tomography with Contrast
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
Idaho
- Saint Alphonsus Cancer Care Center-Boise - Boise
- Saint Luke's Cancer Institute - Boise - Boise
- Saint Alphonsus Cancer Care Center-Caldwell - Caldwell
- Kootenai Health - Coeur d'Alene - Coeur d'Alene
Georgia
- Emory University Hospital Midtown - Atlanta
- Emory University Hospital/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Arkansas
- Mercy Hospital Fort Smith - Fort Smith
- CARTI Cancer Center - Little Rock
California
- Providence Saint Joseph Medical Center/Disney Family Cancer Center - Burbank
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Florida
- Holy Cross Hospital - Fort Lauderdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-04-25 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
What NCT03191149 shows while recruiting
NCT03191149 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 118-participant average among 30 other Recurrent Lung Non-Small Cell Carcinoma trials with a reported enrollment target (61% lower).
The record links to 4 conditions, with Recurrent Lung Non-Small Cell Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03191149 names 20 study sites across 7 states, led by Alaska, Idaho, Georgia.
Frequently Asked Questions
What is clinical trial NCT03191149 about?
NCT03191149 is a clinical study titled "Testing Osimertinib as a Treatment for Lung Cancers With an EGFR Exon 20 Change". This phase II trial studies how well osimertinib works in treating patients with non-small cell lung cancer with EGFR exon 20 insertion mutation that is stage IIIB-IV or has come back after a period of improvement (recurrent). Osimertinib may stop the growth of tumor cells by blocking some of the en...
What is the current status of trial NCT03191149?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2018-04-25. Estimated completion is 2027-06-30.
What conditions does trial NCT03191149 study?
This clinical trial studies the following conditions: Recurrent Lung Non-Small Cell Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Stage IV Lung Non-Small Cell Cancer AJCC v7, Stage IIIB Lung Non-Small Cell Cancer AJCC v7.
What interventions are being tested in trial NCT03191149?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Echocardiography Test (PROCEDURE), Multigated Acquisition Scan (PROCEDURE), Computed Tomography with Contrast (PROCEDURE).
Who is sponsoring clinical trial NCT03191149?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03191149 being conducted?
This trial has 20 study locations across Alaska, Arkansas, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Lung Non-Small Cell Carcinoma
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 NCT03191149's enrollment target sits among peer trials
46 17th of 30 higher than 14 of 30 other Recurrent Lung Non-Small Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Lung Non-Small Cell Carcinoma 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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