Phase 1b/2 Platform Study of Select Immunotherapy Combinations in Participants With Advanced Non-small Cell Lung Cancer (NSCLC)

The study is needed to test three new drugs, S095018, S095024, or S095029, in combination with an approved drug called cemiplimab. The study is intended for patients with non-small cell lung cancer (NSCLC), the most common type of lung cancer.

Normally, the immune system protects the body from foreign substances and fights diseases including cancer cells. However, cancer cells can find ways to escape from immune cells, allowing them to survive and spread. The study drugs and cemiplimab are antibodies (proteins) that help the immune system recognize and attack cancer cells. They do this by blocking proteins (such as TIM3, CD73, NKG2A and PD-1) that help cancer cells escape from the immune system.

S095018 blocks TIM3, S095024 blocks CD73, S095029 blocks NKG2A, and cemiplimab blocks PD-1. Research has shown that these combinations may help more patients with NSCLC who have high levels of PD-L1 in their cancer cells. PD-L1 is a protein that helps cancer cells escape from the immune system by binding to PD-1.

This study has two parts: an open-label part (part A) where both researchers and participants know what treatment is being given, and a randomized part (part B), where participants are put by chance (like the flip of a coin) into one of the groups of treatments.

The main goals of this study are:

• For part A, to see how safe the study drugs are in combination with cemiplimab and to confirm the recommended doses for each combination (the doses that are both safe and effective).
• For part B, to test how well S095018, S095024, or S095029 work in combination with cemiplimab, compared to using cemiplimab alone.