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)
Public ClinicalTrials.gov record NCT04035486. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Open-label, Randomized Study of Osimertinib With or Without Platinum Plus Pemetrexed Chemo, as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation Positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer (FLAURA2).
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 study centre.
Study identification
- NCT ID
- NCT04035486
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 587 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 110 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 1, 2019
- Primary completion
- Apr 2, 2023
- Completion
- Sep 29, 2027
- Last update posted
- Sep 2, 2026
2019 – 2027
United States locations
- U.S. sites
- 23
- U.S. states
- 12
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Bellflower | California | 90706 | — |
| Research Site | Fullerton | California | 92835 | — |
| Research Site | La Jolla | California | 92093 | — |
| Research Site | Santa Monica | California | 90404 | — |
| Research Site | Santa Rosa | California | 95403 | — |
| Research Site | West Hollywood | California | 90048 | — |
| Research Site | Whittier | California | 90602 | — |
| Research Site | Orlando | Florida | 32804 | — |
| Research Site | Tampa | Florida | 33612 | — |
| Research Site | Kansas City | Kansas | 66160 | — |
| Research Site | Louisville | Kentucky | 40202 | — |
| Research Site | Boston | Massachusetts | 02215 | — |
| Research Site | Henderson | Nevada | 89074 | — |
| Research Site | Albany | New York | 12208 | — |
| Research Site | Canton | Ohio | 44710 | — |
| Research Site | Philadelphia | Pennsylvania | 19104 | — |
| Research Site | Pittsburgh | Pennsylvania | 15212 | — |
| Research Site | Pittsburgh | Pennsylvania | 15232 | — |
| Research Site | Houston | Texas | 77090 | — |
| Research Site | San Antonio | Texas | 78240 | — |
| Research Site | Blacksburg | Virginia | 24060 | — |
| Research Site | Fairfax | Virginia | 22031 | — |
| Research Site | Vancouver | Washington | 98684 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 130 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04035486, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 2, 2026 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04035486 live on ClinicalTrials.gov.