Study on the Effectiveness and Safety of BAY 2927088 Compared to Standard Treatment in Patients with Advanced Non-Small Cell Lung Cancer with HER2 Mutations
This clinical trial is focused on studying a type of lung cancer known as advanced non-small cell lung cancer (NSCLC) that has specific changes in the genes called HER2 mutations. The study is testing a new treatment called BAY 2927088, which is taken as a tablet, to see how well it works and how safe it is compared to the usual treatments. The usual treatments include a combination of medicines such as pembrolizumab, pemetrexed, cisplatin, and carboplatin, which are given through an infusion into a vein.
The purpose of the study is to find out if BAY 2927088 can help patients live longer without their cancer getting worse. Participants in the study will be randomly assigned to receive either the new treatment or the standard treatment. The study will monitor the participants over a period of time to see how their cancer responds to the treatment and to check for any side effects.
Throughout the study, participants will have regular check-ups and tests to track their health and the progress of their cancer. The study aims to provide valuable information on whether BAY 2927088 could be a better option for treating this type of lung cancer in the future.
1initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of advanced non-small cell lung cancer with a specific mutation in the HER2 gene.
Eligibility criteria include being 18 years or older and having no prior systemic therapy for advanced disease.
2treatment assignment
Participants are randomly assigned to receive either the experimental treatment or the standard treatment.
The experimental treatment involves taking BAY 2927088 orally in the form of coated tablets.
3standard treatment
The standard treatment consists of a combination of medications administered through intravenous (IV) infusion.
These medications include pembrolizumab, pemetrexed, and either cisplatin or carboplatin.
4treatment duration
The treatment continues for a specified duration, with regular monitoring to assess the response to the therapy.
The primary goal is to evaluate progression-free survival, which means the length of time during and after treatment that the cancer does not worsen.
5monitoring and assessments
Throughout the trial, regular assessments are conducted to monitor the effectiveness and safety of the treatment.
These assessments include imaging tests and evaluations of symptoms and overall health.
6completion of trial
The trial is expected to conclude by May 2028, with final assessments to determine the overall outcomes of the treatments.
Participants will be informed of the results and any further steps if necessary.
Who Can Join the Study?
Participant must be at least 18 years old or older, depending on the legal age of consent in their country, at the time of signing the informed consent.
Must have a confirmed diagnosis of advanced non-squamous non-small cell lung cancer (NSCLC) that cannot be treated with surgery or has spread to other parts of the body. This should be confirmed through specific medical tests. Small cell lung cancer or mixed types are not included.
Must have a specific change, called an activating HER2 mutation, in a part of the cancer cell known as the tyrosine kinase domain. This should be confirmed by a tissue test done in a certified laboratory.
Must not have received any previous treatment for advanced or spreading disease. Also, must not have been treated with medicines targeting the HER2 mutation. If they had treatment after surgery or before surgery, it should have been completed at least 12 months before the start of the study.
Must be eligible to receive a specific type of chemotherapy treatment, which includes medicines like cisplatin/pemetrexed or carboplatin/pemetrexed, along with pembrolizumab, according to the product information.
Who Cannot Join the Study?
Patients with a different type of lung cancer that is not advanced non-small cell lung cancer with a HER2 (ERBB2) mutation cannot participate. The HER2 (ERBB2) mutation is a specific change in the genes that can affect cancer growth.
Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
Patients who are not part of the specified clinical trial groups cannot participate. Clinical trial groups are categories that help organize participants based on certain characteristics.
Patients who are not male or female cannot participate, as the study includes both male and female subjects.
Patients who are considered part of a vulnerable population cannot participate. Vulnerable populations include groups that may need special protection or care.
BAY 2927088 is an experimental medication being tested for its effectiveness and safety in treating patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC) that has certain genetic changes called HER2-activating mutations. This medication is taken by mouth and is being compared to the usual treatments to see if it can help patients live longer without their cancer getting worse.
Advanced Non-Small Cell Lung Cancer with HER2 (ERBB2) Mutation – This is a type of lung cancer characterized by the presence of a specific genetic mutation in the HER2 gene, also known as ERBB2. It is a subtype of non-small cell lung cancer, which is the most common form of lung cancer. The disease typically begins in the tissues of the lungs and can spread to other parts of the body. The HER2 mutation can lead to uncontrolled cell growth, contributing to the progression of the cancer. Symptoms may include persistent cough, chest pain, and difficulty breathing. The progression of the disease can vary, with some patients experiencing rapid advancement while others may have a slower progression.
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