Study of Eftilagimod Alfa (Efti) in Combination With Pembrolizumab and Chemotherapy Versus Placebo in Combination With Pembrolizumab and Chemotherapy in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC) (TACTI-004)

To join this study, you would need to have non-small cell lung cancer that has spread or is advanced. This means your cancer can't be cured with surgery or radiotherapy, and you haven't had treatment for it yet for the advanced stage. You also need to be at least 18 years old.

Before you start, doctors will need to check some things. They will need a sample of your cancer tissue – either an old one you already have or a small piece taken recently. This helps them understand more about your cancer. They'll also check a specific marker in your cancer cells called PD-L1.

There are also specific rules about contraception for both men and women taking part, to prevent pregnancy during the study and for a period after. This includes using effective birth control and refraining from donating sperm or eggs. Pregnancy tests will be done for women before starting any treatment in the study.

If you join this study, you'll be treated for up to two years. You will be randomly assigned to one of two groups: one will receive the new drug (efti) along with your regular cancer treatment (pembrolizumab and chemotherapy), while the other group will get a placebo (a dummy drug) with your regular cancer treatment. You won't know which group you're in, and neither will your doctors – this helps make the study fair.

Throughout the study, you'll have regular hospital visits for your treatments, which will be given through a drip (intravenous infusion). You'll also have tests like blood checks and scans to see how you're responding to the treatment and to keep an eye on your general health. Your doctors will carefully monitor you for any side effects. After your treatment period, there will be follow-up appointments to continue monitoring your health and the cancer's progress.