Summary
This clinical trial is testing new treatment options for people with advanced non-small cell lung cancer (NSCLC) who have a specific gene change called KRAS G12C.
The study is looking at how well these treatments work, how safe they are, and how well people tolerate them. It focuses on people who are starting treatment for the first time for their advanced cancer.
To be eligible for this study, you must not have received prior systemic treatment for locally advanced or metastatic NSCLC, including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation.
What treatments are being studied?
The trial involves two medicines:
- Adagrasib (also called MRTX849) - a targeted therapy tablet that blocks the KRAS G12C mutation, which helps cancer grow.
- Pembrolizumab (Keytruda®) - an immunotherapy drug given by IV infusion that helps your immune system recognise and attack cancer.
The study has two parts: Phase 2 and Phase 3.
Phase 2
This part is testing adagrasib on its own, and adagrasib combined with pembrolizumab. Participants will be placed into groups based on a tumour test called PD-L1.
- There will be two groups of participants with a PD-L1 score less than 1%. These participants will be randomly assigned (by chance) to receive either:
- adagrasib alone, or
- adagrasib in combination with pembrolizumab
- A third group includes participants with a PD-L1 score of 1% or higher. These participants will receive adagrasib together with pembrolizumab.
Phase 3
This part compares adagrasib + pembrolizumab with pembrolizumab alone. The aim is to find out whether adding adagrasib to pembrolizumab improves treatment outcomes. Participants in this part will have a PD-L1 score of 50% or higher.
Participants will be randomly allocated (by chance) to receive either adagrasib + pembrolizumab, or pembrolizumab alone.