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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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 trial?

14 criteria

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 trial?

3 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Universitaire De Bordeaux
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Bordeaux, France
Centre Leon Berard
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Lyon, France
Fakultni Thomayerova nemocnice
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Prague, Czechia

Trial locations

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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.

What is already known about the treatment

Osimertinib – This medication is administered orally and is currently used in the treatment of non-small cell lung cancer (NSCLC) with specific EGFR mutations. It is well-documented in medical literature as an effective first-line treatment for patients with locally advanced or metastatic forms of this cancer. Osimertinib works by inhibiting the activity of the epidermal growth factor receptor (EGFR) at the molecular level, which is crucial for the growth and survival of cancer cells. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

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.