A Phase 2, multicenter, randomized, open-label trial of GEN1046 as monotherapy and in combination with Pembrolizumab in subjects with relapsed/refractory metastatic non-small cell lung cancer after treatment with standard care therapy with a immune checkpoint inhibitor.

This trial is open to adults aged 18 and over who have been diagnosed with advanced or metastatic non-small cell lung cancer. 'Metastatic' means the cancer has spread beyond the lungs to other parts of the body.

To be considered, participants must have already received standard treatment that included an immune checkpoint inhibitor (a common type of immunotherapy), but the cancer must have returned or continued to grow during or after that therapy.

Because this is a clinical trial, there are additional health and safety requirements. People will need to have a general level of fitness that allows them to carry out daily tasks, and their vital organs—such as the heart, liver, and kidneys—must be working reasonably well. Your cancer doctor can look at your full medical history to see if this study is suitable for you.

Taking part in this study involves regular visits to a specialist hospital or clinical trial centre. If you join, you will be assigned to receive either acasunlimab alone or acasunlimab combined with pembrolizumab. Both medicines are given as an infusion (a slow drip into a vein), usually every few weeks.

Before treatment begins and throughout the study, you will have regular health checks. These include blood tests, physical examinations, heart checks, and imaging scans (such as CT or MRI scans) to measure your tumours and see how well the treatment is working.

You will continue receiving the trial treatment for as long as it helps keep your cancer under control and the side effects remain manageable. After finishing treatment, the study team will continue to check on your health and wellbeing through regular follow-up clinic visits or phone calls.