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NCT04035486 · ClinicalTrials.gov registry record · Phase 3
A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)
A Phase 3 study of Non-Small Cell Lung Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 587
- Enrollment target
- 20
- Study locations
NCT04035486 is a Phase 3 study of Non-Small Cell Lung Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 587 participants, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (11% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT04035486, a Phase 3 study of Non-Small Cell Lung Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 587 participants
- Enrollment target
- 20
- Study locations
Study Summary
The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some lung cancers are due to mutations in the Deoxyribonucleic acid (DNA) which, if known, can help physicians decide the best treatment for their patients. One type of mutation can occur in the gene that produces a protein on the surface of cells called the Epidermal Growth Factor Receptor (EGFR). Osimertinib is an Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI) that targets Epidermal Growth Factor Receptor (EGFR) mutations. Unfortunately, despite the benefit observed for patients treated with osimertinib, the vast majority of cancers are expected to develop resistance to the drug over time. The exact reasons why resistance develops are not fully understood but based upon clinical research it is hoped that combining osimertinib with another type of anti-cancer therapy known as chemotherapy will delay the onset of resistance and the worsening of a patient's cancer. In total the study aims to enroll approximately 586 patients, consisting of approximately 30 patients who will participate in a safety run-in component of the trial, and approximately 556 who will receive osimertinib alone or osimertinib in combination with chemotherapy in the main trial. In the main part of the trial there is a one in two chance of receiving osimertinib alone, and the treatment is decided at random by a computer. The study involves a Screening Period, Treatment Period, and Follow up Period. Whilst receiving study medication, it is expected patients will attend, on average, approximately 15 visits over the first 12 months and then approximately 4 visits per year afterwards. Each visit will last about 2 to 6 hours depending on the arrangement of medical assessments by the s
Conditions Studied
Interventions
- DRUG Osimertinib
- DRUG Pemetrexed/Carboplatin
- DRUG Pemetrexed/Cisplatin
Study Locations (20)
California
- Research Site - Bellflower
- Research Site - Fullerton
- Research Site - La Jolla
- Research Site - Santa Monica
- Research Site - Santa Rosa
- Research Site - West Hollywood
- Research Site - Whittier
Pennsylvania
- Research Site - Philadelphia
- Research Site - Pittsburgh
- Research Site - Pittsburgh
Florida
- Research Site - Orlando
- Research Site - Tampa
Texas
- Research Site - Houston
- Research Site - San Antonio
Kansas
- Research Site - Kansas City
Kentucky
- Research Site - Louisville
Massachusetts
- Research Site - Boston
Nevada
- Research Site - Henderson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 587 participants |
| Start Date | 2019-07-02 |
| Est. Completion | 2026-12-22 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04035486
The ClinicalTrials.gov registry entry for NCT04035486 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 587 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (11% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 3 interventions - of which Osimertinib is the first listed.
NCT04035486 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Pennsylvania, Florida.
Frequently Asked Questions
What is clinical trial NCT04035486 about?
NCT04035486 is a clinical study titled "A Study of Osimertinib With or Without Chemotherapy as 1st Line Treatment in Patients With Mutated Epidermal Growth Factor Receptor Non-Small Cell Lung Cancer (FLAURA2)". The reason for the study is to find out if an experimental combination of an oral medication called osimertinib (TAGRISSO®) when used in combination with chemotherapy is more effective than giving osimertinib alone for the treatment of locally advanced or metastatic non-small cell lung cancer. Some ...
What is the current status of trial NCT04035486?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 587 participants. The study started on 2019-07-02. Estimated completion is 2026-12-22.
What conditions does trial NCT04035486 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT04035486?
The interventions under investigation include: Osimertinib (DRUG), Pemetrexed/Carboplatin (DRUG), Pemetrexed/Cisplatin (DRUG).
Who is sponsoring clinical trial NCT04035486?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04035486 being conducted?
This trial has 20 study locations across California, Florida, Kansas, Kentucky, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
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