Study on Osimertinib and Chemotherapy for Patients with Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer

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What is this study about?

This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC) that has specific changes in the EGFR gene, which stands for Epidermal Growth Factor Receptor. These changes, or mutations, are known as Ex19del and L858R. The study is investigating the effectiveness and safety of a medication called osimertinib, also known by its code name AZD9291, when used alone or in combination with chemotherapy. The chemotherapy drugs being used in this study are carboplatin, pemetrexed, and cisplatin. Osimertinib is taken as a tablet, while the chemotherapy drugs are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to compare how well patients respond to treatment with osimertinib alone versus osimertinib combined with chemotherapy. Participants in the study will be randomly assigned to receive either osimertinib by itself or osimertinib with the chemotherapy drugs. The study will monitor the participants over time to see how their cancer responds to the treatment and to check for any side effects. The study aims to provide valuable information on whether adding chemotherapy to osimertinib offers any additional benefits for patients with this type of lung cancer.

Throughout the study, participants will undergo regular check-ups and tests to track their health and the progress of their cancer. These tests may include imaging scans like MRI or CT scans, which help doctors see inside the body to check how the cancer is responding to treatment. The study is expected to continue for several years, allowing researchers to gather comprehensive data on the long-term effects and benefits of the treatments being tested.

1 initial treatment phase

Begin taking osimertinib in the form of TAGRISSO 80 mg film-coated tablets. This medication is taken orally once daily.

This phase involves the use of osimertinib alone as a treatment for non-small cell lung cancer with specific genetic mutations.

2 combination treatment phase

In addition to osimertinib, receive chemotherapy treatments. The chemotherapy includes carboplatin, pemetrexed, and cisplatin, administered through intravenous infusion.

The frequency and duration of these chemotherapy treatments will be determined by the study protocol and your healthcare provider.

3 monitoring and assessment

Regular assessments will be conducted to monitor the effectiveness of the treatment. This includes imaging tests to measure tumor size and progression.

Blood tests and other evaluations will be performed to check for side effects and overall health status.

4 follow-up phase

After completing the treatment phases, follow-up visits will be scheduled to continue monitoring health and any long-term effects of the treatment.

These visits may include additional imaging tests and health assessments.

Who Can Join the Study?

Must be able to give signed informed consent, agreeing to follow the study’s requirements and restrictions.
Must have a WHO PS (World Health Organization Performance Status) of 0 to 1, meaning they are fully active or have some symptoms but do not need to stay in bed, with no significant worsening in the last 2 weeks.
Must have a life expectancy of more than 12 weeks from the start of the study.
Must have at least one tumor that has not been treated with radiation and can be measured accurately using a CT or MRI scan. This tumor should be at least 10 mm in size, except for lymph nodes, which should be at least 15 mm. If there is only one measurable tumor, it can be used if it hasn’t been treated with radiation or biopsied within 14 days before the study starts.
Female patients who are not abstinent and plan to be sexually active with a male partner must use highly effective birth control, not be breastfeeding, and have a negative pregnancy test before the first dose of the study drug. Alternatively, they must show they cannot have children by being post-menopausal or having had certain surgeries.
Male patients must agree to use barrier contraception, like condoms.
Must provide a signed and dated written informed consent form before any study-specific procedures, sampling, and analyses.
If participating in optional genetic testing, must provide signed consent for genetic testing before giving a sample for analysis.
Must be male or female and at least 18 years old, or at least 20 years old if from Japan.
Must have a confirmed diagnosis of nonsquamous NSCLC (Non-Small Cell Lung Cancer), which can include mixed types.
Must have newly diagnosed locally advanced or metastatic NSCLC, or recurrent NSCLC, that cannot be treated with surgery or radiation to cure it.
The tumor must have one of the two common EGFR mutations (Ex19del or L858R) that respond to certain treatments, confirmed by a certified laboratory.
Must provide a baseline blood sample and a stored tumor tissue sample to confirm the EGFR mutation status.
Must have untreated advanced NSCLC that cannot be cured with surgery or radiation. Previous treatments like chemotherapy or radiation are allowed if they were completed at least 12 months before the cancer returned.

Who Cannot Join the Study?

Patients who do not have a specific type of lung cancer called EGFRm Non-Small Cell Lung Cancer cannot participate. This type of cancer involves certain changes in the cancer cells, known as Ex19del and/or L858R mutations.
Patients who are not in the age range specified for the study cannot participate. The study includes certain age groups, so if you are outside these groups, you may not be eligible.
Patients who are part of a vulnerable population, which means they might need special protection or care, are not included in this study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
Nemocnice AGEL Ostrava-Vitkovice a.s.	Ostrava	Czechia
University Hospital Olomouc	Olomouc	Czechia
Fakultni Thomayerova nemocnice	Prague	Czechia
Igrmwdul Rgfjdeia Dn Congpn Dm Mvhsfndbkih	Montpellier	France
Chtkyu Lqun Bbahsd	Lyon	France
Ffyxuepp noxmvqaoe Mjiyk a Hzbdhhp	Prague	Czechia

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	23.05.2024
France	Not recruiting	23.05.2024

Trial locations

Investigated drugs:

Osimertinib is a medication used in this trial as a treatment for patients with a specific type of lung cancer that has certain genetic mutations. It works by targeting and blocking the activity of proteins that help cancer cells grow and spread. This medication is being tested to see how effective it is when used alone or in combination with other treatments.

Platinum-based Chemotherapy is a type of cancer treatment that uses drugs containing the metal platinum. These drugs work by damaging the DNA of cancer cells, which prevents them from dividing and growing. In this trial, platinum-based chemotherapy is combined with other treatments to see if it improves outcomes for patients with lung cancer.

Pemetrexed is a chemotherapy drug used in this trial to treat lung cancer. It works by interfering with the cancer cells’ ability to use folate, a type of vitamin, which is necessary for them to grow and multiply. This medication is being tested in combination with other treatments to determine its effectiveness in improving patient outcomes.

Investigated diseases:

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung. NSCLC is often diagnosed at an advanced stage, where it may have spread to other parts of the body. The disease progresses as cancer cells continue to grow and divide, potentially forming tumors and affecting lung function. Specific genetic mutations, such as EGFR mutations like Ex19del and L858R, can influence the behavior and progression of the cancer. These mutations may also impact how the disease responds to certain treatments.

Trial ID:

2023-508800-39-00

Protocol code:

D5169C00001 FLAURA2

NCT ID:

NCT04035486

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Osimertinib and Chemotherapy for Patients with Advanced EGFR Mutation-Positive Non-Small Cell Lung Cancer

What is this study about?

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