Not recruitingRare disease

Study on Additional Chemotherapy with Osimertinib, Carboplatin, and Cisplatin for Patients with Advanced Non-Small Cell Lung Cancer and EGFR Mutation

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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 Advanced Non-Small Cell Lung Cancer (NSCLC) that has a specific mutation called the EGFR mutation. The study is investigating the effectiveness of adding extra chemotherapy for patients who still have signs of this mutation in their blood after starting treatment with a medication called osimertinib, which is also known by its code name AZD9291. Osimertinib is taken as a tablet and is used as a first-line treatment, meaning it is the first treatment given for this type of cancer.

The purpose of the study is to see if adding chemotherapy can help patients live longer without their cancer getting worse. The chemotherapy drugs being used in this study include carboplatin, cisplatin, and pemetrexed. These drugs are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein. The study will follow patients over a period of time to monitor their health and see how well the treatment is working.

Participants in the study will start with osimertinib treatment and, if needed, will receive additional chemotherapy. The study will track the progression of the disease and any changes in the patients' condition. The goal is to determine if this combination of treatments can improve the time patients live without their cancer progressing. This study is expected to continue until 2026, and it aims to provide valuable information on the best treatment approach for patients with this type of lung cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of treatment
Upon joining the clinical trial, the patient will start treatment with osimertinib. This medication is taken orally in the form of film-coated tablets. The dosage is 80 mg per day.
The patient will continue taking osimertinib daily for up to 28 days as the first-line treatment. This period is crucial for assessing the initial response to the medication.
Step 2
Assessment of ctDNA
Between 21 to 28 days after starting osimertinib, a blood test will be conducted to check for the presence of a specific genetic marker called ctDNA EGFRm. This test helps determine if additional treatment is needed.
Step 3
Additional chemotherapy
If the genetic marker is still present, the patient will begin additional chemotherapy. This involves a combination of medications administered through an intravenous (IV) route.
The chemotherapy regimen includes carboplatin, cisplatin, and pemetrexed. The specific dosages and frequency will be determined by the healthcare team based on individual needs and responses.
Step 4
Ongoing treatment and monitoring
Throughout the trial, the patient will have regular hospital visits for treatment and monitoring. These visits are essential to assess the effectiveness of the treatment and to manage any side effects.
The healthcare team will conduct various tests and evaluations to monitor the patient's health and the progression of the disease.
Step 5
End of trial participation
The trial is expected to continue until September 2026. The patient's participation may end earlier if the disease progresses, if there are significant side effects, or if the patient chooses to withdraw consent.
At the end of the trial, the healthcare team will provide guidance on the next steps for the patient's treatment and care.

Who can join the trial?

17 criteria

Provide written consent to participate in the pre-screening phase of the study.
If you are a woman who cannot have children, you must meet one of the following conditions:
- Be over 50 years old and have not had a period for at least 12 months after stopping hormone treatments.
- If under 50, have not had a period for 12 months or more after stopping hormone treatments, and have hormone levels in the post-menopausal range.
- Have had surgery that permanently prevents pregnancy, such as removal of the uterus or both ovaries.
- Provide consent for the screening and treatment phase before any study-specific procedures.
- Have a persistent **mEGFR ctDNA** signal 21 to 28 days after starting **osimertinib** treatment, as determined by a blood test in the central laboratory. **mEGFR ctDNA** is a marker found in the blood that helps identify certain cancer mutations. **Osimertinib** is a medication used to treat specific types of lung cancer.
- Have an **ECOG performance status** of 0-2, which means you are fully active or have some limitations but can still take care of yourself.
- Be willing and able to follow the study protocol, including attending hospital visits and follow-up examinations.
- Have started **osimertinib** treatment no more than 10 weeks before beginning chemotherapy in the study.
- Be at least 18 years old.
- Have a confirmed diagnosis of stage IIIB or IV **NSCLC**. **NSCLC** stands for non-small cell lung cancer, which is a type of lung cancer.
- Have a tumor that tests positive for **Ex19del** or **L858R EGFR mutation**, according to local standards. These are specific genetic changes found in some lung cancers.
- Plan to be treated with **osimertinib** 80mg daily as the first-line standard of care or have been on this treatment for no more than 28 days.
- Have available chest and abdominal CT or MRI scans done up to 42 days before starting **osimertinib** treatment.
- Have not received any previous systemic treatment for advanced or metastatic disease, except for **osimertinib** for a maximum of 28 days.
- Have at least one measurable site of disease as defined by **RECISTv1.1 criteria**, which is a standard way to measure how well a cancer treatment is working.
- If you are a woman of childbearing potential, you must use highly effective birth control methods, have a negative pregnancy test within 7 days before starting the study treatment, and not be breastfeeding.

Who cannot join the trial?

3 criteria

Patients who do not have advanced NSCLC (a type of lung cancer) with a common EGFR-Mutation cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection, cannot participate.

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Verified sites

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

Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Verified
Mainz, Germany
Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Thoraxklinik Heidelberg gGmbH
Responsive
Heidelberg, Germany

Trial locations

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Investigated drugs

Osimertinib
is a medication used to treat certain types of lung cancer. It works by targeting and blocking specific proteins in cancer cells that help them grow. In this trial, osimertinib is used as the initial treatment to see how well it can control the cancer.
Platinum-based regimen
refers to a group of chemotherapy drugs that contain the metal platinum. These drugs are used to kill cancer cells or stop them from growing. In this trial, the platinum-based regimen is added to the treatment plan if certain cancer markers are still present after starting osimertinib. This combination aims to improve the effectiveness of the treatment by attacking the cancer in a different way.

What is already known about the treatment

Osimertinib – Osimertinib is a medication taken orally, usually in the form of a tablet, and is used to treat advanced non-small cell lung cancer (NSCLC) with specific mutations in the EGFR gene. It is well-established in medical literature as a targeted therapy for this type of cancer. The main therapeutic indication for osimertinib is to inhibit the growth of cancer cells by blocking the activity of the mutated EGFR protein, which is responsible for the uncontrolled division of these cells. Osimertinib belongs to a class of drugs known as tyrosine kinase inhibitors, which work by interfering with the signaling pathways that promote cancer cell growth.

Investigated diseases

Non-Small Cell Lung Cancer with EGFR Mutation – Non-Small Cell Lung Cancer (NSCLC) with an Epidermal Growth Factor Receptor (EGFR) mutation is a type of lung cancer characterized by changes in the EGFR gene, which can lead to uncontrolled cell growth. This mutation is more common in certain populations, such as non-smokers and individuals of Asian descent. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. As it progresses, patients may experience symptoms such as persistent cough, shortness of breath, and chest pain. The cancer can advance through stages, starting from localized tumors to more widespread metastasis. The progression of the disease is often monitored through imaging and clinical assessments.