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NCT04410796 · ClinicalTrials.gov registry record · Phase 2
Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers
A Phase 2 study of Metastatic Non Small Cell Lung Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 571
- Enrollment target
- 18
- Study locations
NCT04410796: Recruiting Phase 2 study of Metastatic Non Small Cell Lung Cancer, sponsored by Memorial Sloan Kettering Cancer Center.
NCT04410796 is a Phase 2 study of Metastatic Non Small Cell Lung Cancer that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 571 participants, above the 364-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (57% higher). The trial reports 18 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04410796, a Phase 2 study of Metastatic Non Small Cell Lung Cancer, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 571 participants
- Enrollment target
- 18
- Study locations
Study Summary
This study will compare the effectiveness of osimertinib alone with the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene EGFR. Osimertinib alone is the usual treatment for metastatic EGFR-mutant lung cancer. Researchers think adding chemotherapy to osimertinib could possibly add to the anticancer effects of the usual treatment and help stop cancer from growing or spreading.
Primary Outcome
As the primary endpoint for the treatment comparison, it is the duration of time from randomization to the time of disease progression (in the CNS or systemically) or death. In addition, as a secondary endpoint, PFS is measured from the start of treatment to disease progression or death. Intracranial progression-free survival (PFS) is defined as the duration of time from time of randomization to time of progression (in the CNS) or death, whichever occurs first. Overall survival (OS) is defined a
Conditions Studied
Interventions
- DRUG Carboplatin
- DRUG Osimertinib
- DRUG Pemetrexed
Study Locations (18)
New York
- Memorial Sloan Kettering Commack (Limited protocol activities) - Commack
- Memorial Sloan Kettering Westchester (Limited protocol activities) - Harrison
- New York University - New York
- Columbia University (Data Collection Only) - New York
- Memorial Sloan Kettering Cancer Center (All protocol activities) - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Hackensack Meridian Health - Hackensack
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
California
- UC Davis Cancer Center (Data Collection Only) - Sacramento
- University of California San Francisco - San Francisco
Florida
- Moffitt Cancer Center - Tampa
Maryland
- John Hopkins Medical Center - Baltimore
Massachusetts
- Massachusetts General Hospital (Data Collection Only) - Boston
Tennessee
- Sarah Cannon Research Institute - Nashville
Texas
- MD ANDERSON CANCER CENTER (Data Collection Only) - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 571 participants |
| Start Date | 2020-05-28 |
| Est. Completion | 2026-05 |
| Phase | Phase 2 |
What NCT04410796 shows while recruiting
NCT04410796 is an interventional study that assigns participants to a tested intervention. The registered 571 participants enrollment target is mid-sized for trials with a published cap, above the 364-participant average among 31 other Metastatic Non Small Cell Lung Cancer trials with a reported enrollment target (57% higher).
The record links to 1 condition, with Metastatic Non Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Carboplatin is the first listed.
NCT04410796 lists 18 locations in 9 states (New York, New Jersey, California).
Frequently Asked Questions
What is clinical trial NCT04410796 about?
NCT04410796 is a clinical study titled "Osimertinib Alone or With Chemotherapy for EGFR-Mutant Lung Cancers". This study will compare the effectiveness of osimertinib alone with the combination of osimertinib and chemotherapy (carboplatin and pemetrexed) in people with metastatic lung cancer that has a change (mutation) in the gene EGFR. Osimertinib alone is the usual treatment for metastatic EGFR-mutant lu...
What is the current status of trial NCT04410796?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 571 participants. The study started on 2020-05-28. Estimated completion is 2026-05.
What conditions does trial NCT04410796 study?
This clinical trial studies the following conditions: Metastatic Non Small Cell Lung Cancer.
What interventions are being tested in trial NCT04410796?
The interventions under investigation include: Carboplatin (DRUG), Osimertinib (DRUG), Pemetrexed (DRUG).
Who is sponsoring clinical trial NCT04410796?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04410796 being conducted?
This trial has 18 study locations across California, Florida, Maryland, Massachusetts, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04410796's enrollment target sits among peer trials
571 8th of 31 higher than 24 of 31 other Metastatic Non Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic 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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