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)

Part of paid clinical trials in Bellflower, California.

Sponsor
AstraZeneca
Study ID
NCT04035486
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 110 Years
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Drug: Osimertinib (Oral) Other Names: AZD9291
  • Pemetrexed/Carboplatin — DRUG
    Drug: Pemetrexed (500 mg/m2) plus carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
  • Pemetrexed/Cisplatin — DRUG
    Drug: Pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.

Study Details

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.

Key Dates

Start date
Jul 2, 2019
Status verified
Sep 2025
Primary completion
Apr 3, 2023
Completion
Dec 22, 2026

Study Design

Enrollment
587 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Osimertinib 80mg QD
    Osimertinib (AZD9291) 80mg QD. All patients randomized into this will only receive Osimertinib 80mg. Dose may be reduced to allow for the management of IP related toxicity.
  • Experimental: Osimertinib 80 mg QD and platinum-based chemotherapy
    Osimertinib 80 mg in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks. Dose may be reduced to allow for the management of IP related toxicity.

Primary Outcome Measure

Adverse Events Graded by Common Terminology Criteria for Adverse Event v5 (Safety Run-In Treatment Arms Only) [ Time Frame: From first dose date to 28 days following last dose, up to 45 months ]

Locations (23)

FacilityCityStateZIPSite coordinators
Research SiteBellflowerCalifornia90706-
Research SiteFullertonCalifornia92835-
Research SiteLa JollaCalifornia92093-
Research SiteSanta MonicaCalifornia90404-
Research SiteSanta RosaCalifornia95403-
Research SiteWest HollywoodCalifornia90048-
Research SiteWhittierCalifornia90602-
Research SiteOrlandoFlorida32804-
Research SiteTampaFlorida33612-
Research SiteKansas CityKansas66160-
Research SiteLouisvilleKentucky40202-
Research SiteBostonMassachusetts02215-
Research SiteHendersonNevada89074-
Research SiteAlbanyNew York12208-
Research SiteCantonOhio44710-
Research SitePhiladelphiaPennsylvania19104-
Research SitePittsburghPennsylvania15212-
Research SitePittsburghPennsylvania15232-
Research SiteHoustonTexas77090-
Research SiteSan AntonioTexas78240-
Research SiteBlacksburgVirginia24060-
Research SiteFairfaxVirginia22031-
Research SiteVancouverWashington98684-

Find similar trials in Bellflower, CA

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Research Site· Bellflower, CAResearch Site· Fullerton, CAResearch Site· La Jolla, CAResearch Site· Santa Monica, CAResearch Site· Santa Rosa, CAResearch Site· West Hollywood, CA

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