Summary
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and a leading cause of cancer-related death worldwide.
You may be eligible for this study if you have non-squamous (NSq) NSCLC that is locally advanced or metastatic. There are different criteria regarding prior treatment history for each stage of the study. Please speak with your doctor about whether you may be eligible.
This study is looking at how safe and effective a new treatment approach is for people with NSCLC. It is testing a medicine called telisotuzumab adizutecan (ABBV-400) when given together with immunotherapy. Telisotuzumab adizutecan (ABBV-400) and budigalimab are new (investigational) drugs that are still being tested.
The study has two stages.
Stage 1 (dose escalation)
- Participants receive increasing doses of telisotuzumab adizutecan together with budigalimab.
- This helps researchers find a dose that is safe and likely to work well.
Stage 2 (dose optimisation)
Participants are divided into three treatment groups:
- Telisotuzumab adizutecan at one dose level + pembrolizumab (immunotherapy)
- Telisotuzumab adizutecan at another dose level+ pembrolizumab
- Standard treatment (current usual care), which includes pembrolizumab and chemotherapy
What participation invovles
- Treatment is given through a drip into a vein (intravenous infusion)
- The study will last about 33 months
- You will need to attend regular visits at a hospital or clinic
During the study, doctors will closely monitor your health using:
- Medical checkups
- Blood tests
- Questionnaires
- Monitoring of any side effects
Being in this study may involve more visits and tests than standard treatment. The goal is to understand how well these new treatments work and how safe they are.