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Study on Osimertinib and Chemotherapy for Stage IV Non-Small Cell Lung Cancer with Atypical EGFR Mutations

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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 stage IV non-small-cell lung cancer (NSCLC). This specific study is for patients who have certain unusual changes, called mutations, in a gene known as EGFR. The purpose of the study is to evaluate how effective a treatment combination is for these patients. The treatment involves a medication called osimertinib, which is also known by its code name AZD9291, combined with chemotherapy drugs. The chemotherapy drugs used in this study include pemetrexed, carboplatin, and cisplatin. These medications are given to help stop the cancer cells from growing and spreading.

Participants in the study will receive the treatment as a first-line therapy, meaning it is the first treatment they will receive for their cancer. The study will monitor how well the treatment works over time, including how long patients live without their disease getting worse. The treatment with osimertinib is taken orally in the form of film-coated tablets, while the chemotherapy drugs are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The study will take place over a period of time, with regular check-ups to see how the patients are responding to the treatment. The goal is to understand if this combination of medications can help improve the outcomes for patients with this specific type of lung cancer. The study will also look at the safety of the treatment and any side effects that may occur. This research is important for finding better ways to treat patients with NSCLC who have these specific EGFR mutations.

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
Beginning of treatment
Upon joining the clinical trial, you will start your treatment for stage IV non-small-cell lung cancer (NSCLC) with specific genetic mutations. The treatment involves a combination of medications, including osimertinib and chemotherapy drugs.
You will receive osimertinib orally. The dosage will be either 80 mg or 40 mg, depending on your specific treatment plan. This medication is taken daily in the form of film-coated tablets.
Step 2
Chemotherapy administration
In addition to osimertinib, you will receive chemotherapy drugs through intravenous infusion. These drugs include pemetrexed, carboplatin, and cisplatin. The specific dosage and frequency will be determined by your healthcare provider based on your individual needs.
The chemotherapy sessions will be scheduled at regular intervals, and the duration of each session will be communicated to you by the medical team.
Step 3
Monitoring and follow-up
Throughout the trial, your health and response to the treatment will be closely monitored. This includes regular check-ups, blood tests, and imaging studies to assess the effectiveness of the treatment and to ensure your safety.
You will be informed about the schedule for these follow-up appointments and any additional tests that may be required.
Step 4
End of treatment
The treatment period will continue as planned unless there are reasons to stop earlier, such as significant side effects or disease progression. The estimated end date for the trial is April 2, 2029.
After completing the treatment, there will be a final evaluation to assess your overall health and the outcomes of the trial.

Who can join the trial?

20 criteria

Patient has provided written informed consent.
Patient is 18 years or older at the time of signing the informed consent form.
Patient has stage IV NSCLC (a type of lung cancer) confirmed by tests.
Patient has not received prior treatment for the cancer that has spread.
Patient has specific EGFR mutations (changes in a gene related to cancer) in Exons 18-21, but not the L858R, Exon 19 del, Exon 20 Ins, or T790M mutations.
Patient has negative test results for ALK and ROS1 alterations (other gene changes related to cancer).
Patient has an ECOG performance status of 0 or 1, which means they are fully active or have some symptoms but do not need to stay in bed.
Patient must have a life expectancy of at least 12 weeks.
Patient has at least one measurable tumor according to RECIST v1.1 (a standard way to measure cancer response to treatment).
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Patient has adequate liver, kidney, and bone marrow function, which includes:
- Hemoglobin (a protein in red blood cells) level of at least 9.0 g/dL.
- Absolute neutrophil count (a type of white blood cell) of at least 1.5 x 10⁹/L.
- Platelets (cells that help with blood clotting) of at least 100 x 10⁹/L.
- Creatinine clearance (a measure of kidney function) of at least 60 mL/min and creatinine level within normal limits.
- Serum bilirubin (a substance made by the liver) within normal limits, or higher if there is a specific condition like Gilbert's Syndrome or liver metastases.
- AST/ALT and alkaline phosphatase (liver enzymes) within normal limits, or higher if there are liver metastases.
- INR/aPTT (blood clotting tests) within normal limits unless on blood thinners.
- Female patients who can have children must agree to use effective birth control or not have heterosexual intercourse during treatment and for a period after treatment ends.
- Female patients must have a negative pregnancy test and not be breastfeeding before starting treatment.
- Male patients with partners who can have children must agree to use condoms or not have heterosexual intercourse during treatment and for a period after treatment ends.
- Male patients with pregnant partners must agree to use condoms or not have intercourse during the pregnancy.

Who cannot join the trial?

5 criteria

Patients with a different type of cancer other than stage IV NSCLC (non-small-cell lung cancer) cannot participate.
Patients with EGFR mutations that are not atypical, such as L858R, Exon 19 deletion, Exon 20 insertion, or T790M mutation, are excluded. EGFR mutations are changes in a gene that can affect how cancer grows.
Patients who are not within the specified age range for the study cannot participate.
Patients who are not able to follow the study procedures or take the study medication as required will be excluded.
Patients with any other medical condition that the study doctors think might make it unsafe for them to participate will be excluded.

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Verified sites

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

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Goethe University Frankfurt
Frankfurt, Germany
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Justus-Liebig-Universitaet Giessen
Giessen, Germany
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Klinikum der Universitaet Muenchen AöR
Munich, Germany

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Investigated drugs

Osimertinib
is a medication used in this clinical trial to treat patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC). It works by targeting and blocking certain proteins that help cancer cells grow and spread. This medication is particularly used for patients who have specific mutations in their cancer cells, making it a targeted therapy that aims to slow down or stop the progression of the disease.
Chemotherapy
is a type of cancer treatment that uses drugs to destroy cancer cells. In this trial, chemotherapy is used alongside osimertinib to enhance the treatment's effectiveness. Chemotherapy works by attacking rapidly dividing cells, which include cancer cells, and can help reduce the size of tumors or slow their growth. It is a common treatment for many types of cancer and is used here to support the action of osimertinib in fighting the disease.

What is already known about the treatment

Osimertinib – Osimertinib is a medication administered orally in the form of a tablet. It is currently being studied in clinical trials as a first-line treatment for patients with stage IV non-small-cell lung cancer (NSCLC) who have specific atypical mutations in the EGFR gene. The main therapeutic use of osimertinib is to target and inhibit the activity of the EGFR protein, which is often overactive in certain types of cancer cells, leading to their growth and spread. By blocking this protein, osimertinib helps to slow down or stop the progression of the cancer. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) Stage IV – This is a type of lung cancer that begins in the tissues of the lung and is characterized by the presence of large cells. In stage IV, the cancer has spread beyond the lungs to other parts of the body, such as the bones, brain, or liver. The disease progresses as cancer cells grow and multiply, forming tumors that can interfere with the function of affected organs. As the cancer spreads, it can cause symptoms like persistent cough, chest pain, and difficulty breathing. The progression of the disease can lead to further complications as it affects more areas of the body. The spread of cancer cells to distant organs is a key feature of this advanced stage.