Upon joining the trial, you will be randomly assigned to one of two treatment groups. This process is similar to flipping a coin and ensures fairness in the study.

One group will receive izalontamab brengitecan (also called iza-bren), and the other group will receive platinum-based chemotherapy (also called PBC), which includes drugs such as cisplatin or carboplatin combined with gemcitabine.

If you are assigned to the izalontamab brengitecan group, you will receive this medication through an intravenous infusion, which means it will be given directly into your vein.

The trial includes two phases. In Phase 2, the appropriate dose of iza-bren will be determined. In Phase 3, this established dose will be used to compare the effectiveness of the treatment.

The specific dosage, frequency, and duration of treatment with iza-bren will be determined by the trial protocol and your response to the medication.

If you are assigned to the platinum-based chemotherapy group, you will receive a combination of medications through intravenous infusion, meaning they will be given directly into your vein.

The treatment may include cisplatin or carboplatin combined with gemcitabine. The choice between cisplatin and carboplatin will depend on your ability to tolerate these medications.

You may also receive pegfilgrastim as a subcutaneous injection, which means it will be given under your skin. This medication helps your body produce white blood cells and may reduce the risk of infections during chemotherapy.

The specific dosage, frequency, and duration of each medication will be determined by the trial protocol.

Throughout the trial, you will undergo regular assessments to monitor how the treatment is working and to check for any side effects.

These assessments will include measurements of progression-free survival, which refers to the time from the start of treatment until your disease worsens or death occurs, whichever comes first.

Your overall survival, meaning how long you live, will also be tracked.

Other measurements will include the objective response rate, which shows what proportion of patients respond to treatment, time to response, which indicates how long it takes for you to respond to treatment, and duration of response, which measures how long your response to treatment lasts.

If you are participating in Phase 3 of the trial, you will be asked to complete questionnaires about your quality of life.

These assessments will measure the time it takes for you to report a decline in your quality of life, and the results will be compared between the two treatment groups.

Throughout the trial, your safety will be closely monitored. This includes checking for any side effects or adverse reactions to the medications.

Information about the safety and tolerability of the treatments will be collected and reviewed regularly.

In Phase 2, this information will help determine the recommended dose of iza-bren for Phase 3.

You will continue to receive your assigned treatment according to the trial protocol.

The duration of your participation in the trial will depend on how your disease responds to treatment and your overall health.

The trial is estimated to continue until October 2029, though your individual participation may be shorter or longer depending on your specific circumstances.