Summary
Researchers are investigating zongertinib in combination with chemotherapy, with or without immunotherapy, for people with advanced non-small cell lung cancer that has a HER2 gene mutation.
The main aim is to find out how safe and tolerable zongertinib is when used together with chemotherapy, with or without the immunotherapy drug pembrolizumab.
Zongertinib works by targeting and blocking HER2, a protein involved in cancer cell growth.
Who can take part?
You may be eligible for this study if you:
- are aged 18 years or older
- have non-squamous non-small cell lung cancer (NSCLC)
- have a HER2 mutation in your tumour
- have locally advanced or metastatic disease
- have not received previous treatment for your lung cancer
Study details
Participants are randomly assigned (by chance) to one of two treatment groups:
- Zongertinib tablets plus platinum-based chemotherapy
- Zongertinib tablets plus platinum-based chemotherapy and pembrolizumab (an immunotherapy)
Zongertinib is taken by mouth once a day.
Chemotherapy and pembrolizumab are given through a drip into a vein (IV infusion). Chemotherapy is given every 3 weeks for up to 3 months, followed by maintenance treatment for up to 2 years. Participants in the immunotherapy group receive pembrolizumab every 3 weeks for up to 2 years.
How long does the study go for?
The study does not have a set end date.
Participants may receive some study treatments for up to 2 years. People who are benefiting from zongertinib and tolerating it well may continue taking it for longer.
During the study, participants will attend regular clinic visits. The study team will monitor tumour size and whether the cancer has spread, check participants' overall health, and record any side effects or unwanted effects from treatment.