In short
Clinical trials are studying SEVABERTINIB in people with HER2-mutated cancers, including advanced solid tumors and advanced non-small cell lung cancer. These trials are checking how well the treatment works and how safe it is, and they compare it with standard treatment in some studies. The main goals include tumor response and time without cancer growth.
Key points
- SEVABERTINIB is being studied in clinical trials for cancers with HER2 mutations. One Phase 2 trial is in people with advanced solid tumors, and one Phase 3 trial is in people with advanced non-small cell lung cancer. The studies are looking at how well the treatment works and how safe it is. The Phase 2 study measures objective response rate, while the Phase 3 study measures progression free survival. Both trials are authorised and are testing SEVABERTINIB in adults with HER2-related cancer.
Trial overview
Clinical trials are studying SEVABERTINIB in cancers with HER2 mutations, which are changes in the HER2 gene that may help cancer grow. The available trials focus on two groups: people with advanced solid tumors and people with advanced non-small cell lung cancer (NSCLC). Both studies are marked as Authorised.
Who is being studied
One trial includes participants with a solid tumor and a HER2 mutation, which means a cancer starting in a solid organ or tissue with a change in the HER2 gene. This study is not limited to one cancer type and looks at advanced solid tumors more broadly.
The other trial includes participants with advanced NSCLC and a HER2 (ERBB2) mutation. ERBB2 is another name used for the HER2 gene, so both terms point to the same target in the trial record.
Trial phases and study design
The first study is a Phase 2 interventional trial with 111 planned participants. Phase 2 trials usually look more closely at whether a treatment shows signs of benefit and whether it can be given safely in the study group.
The second study is a Phase 3 interventional trial with 444 planned participants. Phase 3 trials are later-stage studies that often compare a study treatment with standard treatment in a larger group.
The Phase 3 study compares SEVABERTINIB with standard treatment, also called SoC. The trial record lists several standard treatment drugs in the comparison group, including cisplatin, pemetrexed, pembrolizumab, and carboplatin.
What the trials measure
The Phase 2 study measures objective response rate (ORR), using RECIST 1.1 and blinded independent central review (BICR). ORR means the share of participants whose tumors shrink or disappear, and BICR means independent experts review scan results without knowing which treatment was given.
The Phase 3 study measures progression free survival (PFS), also assessed by RECIST 1.1 and BICR. PFS is the time people live without the cancer getting worse, so it is a key way to see whether the treatment helps control the disease.
Both studies also aim to learn about safety and overall treatment effect in their target populations.
Trial details
The Phase 2 study is titled as a study to learn more about how well treatment with sevabertinib (BAY2927088) tablets works and how safe it is in participants with a solid tumor and HER2 mutations. The intervention list shows oral SEVABERTINIB tablet strengths of 30 mg and 40 mg.
The Phase 3 study is titled as a study to learn more about how well SEVABERTINIB works and how safe it is compared with standard treatment in participants with advanced NSCLC and HER2 mutations. The intervention list includes oral SEVABERTINIB and comparison medicines used in standard care.
In simple terms, the first trial asks whether the treatment can shrink tumors in a mixed group of HER2-mutated solid cancers, while the second asks whether it can keep lung cancer from getting worse longer than standard treatment.
Key patient terms
Interventional study means researchers give a treatment and track what happens. Authorised means the study has been approved to move forward.
Enrollment is the number of people the study plans to include. Primary outcome is the main result the trial is designed to measure.