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)

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 study centre.

Conditions

• Non-Small Cell Lung Cancer

Interventions

DRUG

Osimertinib

Drug: Osimertinib (Oral) Other Names: AZD9291

DRUG

Pemetrexed/Carboplatin

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.

DRUG

Pemetrexed/Cisplatin

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.

Sponsors & Collaborators

• AstraZeneca

  lead INDUSTRY

Principal Investigators

• Pasi A. Jänne, MD · Dana Farber Cancer Institute, 450 Brookline Avenue, LC4114, Boston, MA 02215, USA

• Kunihiko Kobayashi, MD · Department of Respiratory Medicine, Saitama Medical University International Medical Center, Saitama, Japan

• David Planchard, MD · Department of Medical Oncology - Institut Gustave Roussy (IGR) - Villejuif - France

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-02

Primary Completion

2023-04-03

Completion

2026-12-22

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Brazil
• Canada
• Chile
• China
• Czechia
• France
• India
• Japan
• Peru
• Philippines
• Russia
• Slovakia
• South Africa
• South Korea
• Taiwan
• Thailand
• United Kingdom
• Vietnam

Study Locations