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Study on the Effect of Ivonescimab, Pemetrexed, and Carboplatin in Patients with Advanced Non-Small Cell Lung Cancer with EGFR Mutation After Previous Treatment

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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 epidermal growth factor receptor (EGFR) gene. This type of cancer is called EGFR-mutant NSCLC. The study is for patients whose cancer has advanced locally or spread to other parts of the body and who have not responded to previous treatments with drugs called EGFR tyrosine kinase inhibitors (TKIs). The trial aims to evaluate the effectiveness of a new treatment combination involving a study drug known as ivonescimab (also referred to as AK112 or SMT112) along with two chemotherapy drugs, pemetrexed and carboplatin. Some patients will receive a placebo instead of ivonescimab, combined with the same chemotherapy drugs.

The purpose of the study is to compare the overall survival and progression-free survival of patients receiving the combination of ivonescimab, pemetrexed, and carboplatin with those receiving the placebo, pemetrexed, and carboplatin. The study will be conducted in a double-blind manner, meaning neither the patients nor the researchers will know who is receiving the study drug or the placebo. This helps ensure that the results are not biased. The treatment will be administered through an intravenous drip, which means the medication is given directly into a vein over a period of time.

Participants in the study will receive treatment for a maximum period of 24 weeks, with regular monitoring to assess the effectiveness and safety of the treatment. The study will also evaluate the presence of any side effects and the body's immune response to the study drug. The trial is expected to continue until the end of 2025, with the goal of providing valuable information on the potential benefits of this new treatment combination for patients with EGFR-mutant NSCLC.

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 visit
Upon joining the study, you will attend an initial visit where medical staff will review your medical history and confirm your eligibility. This includes checking your performance status and ensuring you have a life expectancy of at least 3 months.
You will undergo tests to confirm the presence of specific mutations in your cancer and to ensure you have previously received and not responded to certain treatments.
Step 2
Treatment phase
During the treatment phase, you will receive a combination of medications through an intravenous drip. This means the medication will be administered directly into your bloodstream through a vein.
The medications include carboplatin and pemetrexed, which are chemotherapy drugs, and possibly ivonescimab or a placebo. The specific dosage and frequency will be determined by the study protocol.
Step 3
Regular monitoring
Throughout the trial, you will have regular appointments to monitor your health and the effects of the treatment. This includes blood tests, imaging scans, and assessments of your overall well-being.
The study team will also monitor for any side effects or adverse reactions to the treatment.
Step 4
Follow-up visits
After completing the treatment phase, you will have follow-up visits to assess your response to the treatment and to monitor your health.
These visits will help determine the long-term effects of the treatment and gather data for the study.

Who can join the trial?

8 criteria

Must have a performance status of 0 or 1 according to the Eastern Cooperative Oncology Group (ECOG). This means you should be fully active or have some symptoms but can still do light work.
Must have a life expectancy of at least 3 months.
Must have locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) that cannot be treated with surgery, radiation, or standard chemotherapy. This means the cancer has spread beyond the original site and cannot be removed or treated with standard methods.
The presence of EGFR activating mutations must be confirmed by a test before joining the study. EGFR mutations are changes in a specific gene that can affect cancer growth.
Must have previously received treatment with EGFR-TKI and the treatment did not work. EGFR-TKI is a type of medication that targets the EGFR mutations.
Must have at least one measurable tumor outside the brain, as determined by specific criteria called RECIST v1.1.
Must have major organ function that meets specific criteria before starting treatment. This means your vital organs like the heart, liver, and kidneys should be working well enough.
If you are of childbearing potential, you must agree to use highly effective contraceptive measures to prevent pregnancy during the study.

Who cannot join the trial?

4 criteria

Patients who do not have a specific type of lung cancer called EGFR-mutant non-squamous non-small cell lung cancer (NSCLC) that has spread or is locally advanced.
Patients who have not previously been treated with EGFR-TKI therapy, which is a type of medication that targets specific proteins in cancer cells.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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

Azienda Ospedaliero Universitaria Parma
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Parma, Italy
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
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Madrid, Spain
Istituto Europeo Di Oncologia S.r.l.
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Milan, Italy

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Investigated drugs

AK112
is an experimental medication being tested in this clinical trial. It is being studied to see if it can help patients with a specific type of lung cancer, known as non-squamous non-small cell lung cancer, which has certain genetic changes called EGFR mutations. These patients have already tried other treatments that target these mutations, but their cancer has continued to grow. AK112 is being combined with other cancer-fighting drugs to see if it can improve survival and slow down the progression of the disease.
Pemetrexed
is a medication used in this trial that helps to stop the growth of cancer cells. It works by interfering with the cancer cells' ability to make and repair DNA, which is essential for their growth and survival. Pemetrexed is often used in combination with other drugs to treat certain types of lung cancer, including the type being studied in this trial.
Carboplatin
is another medication used in this trial. It is a type of chemotherapy that works by damaging the DNA of cancer cells, which prevents them from dividing and growing. Carboplatin is commonly used to treat various types of cancer, including lung cancer, and is often used in combination with other cancer treatments to enhance its effectiveness.

What is already known about the treatment

AK112 – AK112 is administered intravenously, meaning it is given through a vein, typically in a hospital or clinical setting. It is currently being studied in clinical trials and is not yet widely available in medical practice. This medication is being tested for its effectiveness in treating patients with a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that has certain genetic mutations and has not responded to previous treatments. AK112 works by targeting specific proteins involved in cancer cell growth, aiming to slow down or stop the progression of the disease. It is classified as an investigational drug, meaning it is still under research to determine its safety and effectiveness.

Investigated diseases

Non-squamous Non-small Cell Lung Cancer with EGFR Mutations – This type of lung cancer is characterized by the presence of mutations in the epidermal growth factor receptor (EGFR) gene. It primarily affects the cells lining the air passages in the lungs and is not of the squamous cell type. The disease often begins with symptoms such as a persistent cough, shortness of breath, and chest pain. As it progresses, the cancer can spread to other parts of the body, including the bones and brain. The progression is typically marked by an increase in tumor size and the development of additional symptoms related to the areas affected by metastasis. The disease is known to progress despite initial treatment with EGFR tyrosine kinase inhibitors.