Study of Amivantamab, a Human Bispecific EGFR and cMet Antibody, in Participants With Advanced Non-Small Cell Lung Cancer

To join this study, you must have non-small cell lung cancer that has spread or cannot be removed by surgery. You also need to have already tried standard treatments that didn’t work, or your doctors decide that other available treatments are not suitable for you. You must be willing to receive Amivantamab along with standard chemotherapy if you're in that part of the study.

For some parts of the study, specifically when Amivantamab is combined with another drug called Lazertinib, your lung cancer must have a specific change in your genes (called an EGFR mutation, either Exon 19del or L858R). You might be eligible if you haven't received treatment for advanced disease, or if you've already had certain targeted therapies (called first, second, or third-generation TKIs). If you're in the part of the study testing Amivantamab with chemotherapy, your cancer can have an EGFR mutation or not.

Generally, you need to be at least 18 years old to take part. The study team will review your full medical history and test results to see if you meet all the requirements. It’s important to remember that these are just some of the main criteria; your doctor will be able to tell you all the details.

If you decide to take part in this study, it will involve several visits to the clinic. First, there's a 'screening' period, which could last up to 28 days, where doctors will do tests to make sure the study is right for you. If you qualify, you'll then enter the 'treatment period,' which starts when you receive your first dose of the study medicine.

During the treatment period, you'll receive Amivantamab, either alone or with Lazertinib, or with standard chemotherapy (Carboplatin and Pemetrexed). The frequency and how you receive these medicines (for example, through an injection into a vein) will depend on which group you're in. Treatment cycles are either 28 days or 21 days long. You'll have regular checks, blood tests, and scans to monitor your health, how the drug is working, and any side effects.

The treatment period continues until about 30 days after your last dose of the study drug, or if you need to start other cancer treatments. After the treatment period, you'll enter a 'follow-up period' that lasts for approximately 6 months. During this time, doctors will keep track of your health. All participants will also be followed up for their survival until the study officially ends.