Your treatment will be assigned based on which part of the trial you are enrolled in. The trial consists of three parts: Part 1 (Dose Escalation), Part 2a (Dose Expansion), and Part 2b (Dose Optimization).

All parts involve receiving BNT326 in combination with BNT327. These are investigational medications that will be given to you through intravenous infusion, which means they will be administered directly into your vein.

Depending on your specific treatment group, you may also receive additional medications such as carboplatin, pembrolizumab, pemetrexed, or paclitaxel. All medications are given through intravenous infusion.

You will need to provide a tumor tissue sample. This can be from previously collected tissue stored from an earlier procedure, known as archival tissue.

If archival tissue is not available, a fresh biopsy may need to be collected. A biopsy is a procedure where a small sample of tumor tissue is removed for testing. This will only be done if it is medically appropriate for your situation.

Before starting treatment, your organ and bone marrow function will be assessed within 7 days before treatment begins. This involves blood tests to ensure your body can safely receive the medications.

Your disease status will be evaluated to confirm you have measurable disease. This means your tumor can be measured using imaging scans, following specific criteria known as RECIST v1.1.

You will begin receiving the study medications. BNT326 and BNT327 will be administered as intravenous infusions.

If you are in Part 1 (Dose Escalation), you will be monitored closely during a specific period called the dose limiting toxicity evaluation period. During this time, your medical team will watch for any serious side effects that might require adjusting the dose.

The treatment will be given in cycles. The specific dosage, frequency, and duration will depend on which part of the trial you are in and how your body responds to the treatment.

Throughout your treatment, you will be monitored for any adverse events, which are unwanted side effects or health problems that occur during the trial.

Your medical team will track treatment emergent adverse events, which are any health issues that develop or worsen after you start taking the study medications.

Blood samples will be collected at various times to measure the levels of the study medications in your body. This is called pharmacokinetic assessment and helps understand how your body processes these medications.

Your tumor will be assessed regularly using imaging scans to determine how well the treatment is working.

The medical team will look for signs of objective response, which includes whether your tumor has shrunk significantly (partial response) or disappeared completely (complete response).

These assessments will also determine if your disease has remained stable or if there has been tumor progression, meaning the cancer has grown or spread.

Blood samples will be taken to check for anti-drug antibodies. These are proteins your immune system might produce in response to the study medications.

This testing helps determine if your body is developing an immune response to the treatment, which could affect how well the medications work.

Depending on how you tolerate the treatment, your dose may need to be interrupted, reduced, or discontinued.

These adjustments are made based on any adverse events you experience to ensure your safety while receiving treatment.

You will continue receiving treatment cycles as long as the treatment is benefiting you and you are tolerating it well.

Your progression-free survival will be tracked, which measures the length of time from starting treatment until your cancer progresses or death occurs.

Your duration of response will be measured if your tumor responds to treatment. This tracks how long your tumor remains shrunk or stable after responding to the medications.

Your overall survival will also be followed, which measures the time from starting treatment until death from any cause.

Even after you stop receiving the study medications, you will continue to be monitored for your health status and disease progression.

The trial is expected to continue collecting information until approximately January 2029, though your individual participation duration may vary.