Table of Contents
- Trial overview
- Who is being studied
- Trial phases and study design
- What the trials measure
- Trial details
- Key patient terms
Trial overview
Clinical trials are studying SEVABERTINIB in cancers with HER2 mutations, which are changes in the HER2 gene that may help cancer grow.[1][2] The available trials focus on two groups: people with advanced solid tumors and people with advanced non-small cell lung cancer (NSCLC).[1][2] Both studies are marked as Authorised.[1][2]
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.[1] This study is not limited to one cancer type and looks at advanced solid tumors more broadly.[1]
The other trial includes participants with advanced NSCLC and a HER2 (ERBB2) mutation.[2] ERBB2 is another name used for the HER2 gene, so both terms point to the same target in the trial record.[2]
Trial phases and study design
The first study is a Phase 2 interventional trial with 111 planned participants.[1] 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.[2] 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.[2] The trial record lists several standard treatment drugs in the comparison group, including cisplatin, pemetrexed, pembrolizumab, and carboplatin.[2]
What the trials measure
The Phase 2 study measures objective response rate (ORR), using RECIST 1.1 and blinded independent central review (BICR).[1] 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.[1]
The Phase 3 study measures progression free survival (PFS), also assessed by RECIST 1.1 and BICR.[2] 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.[2]
Both studies also aim to learn about safety and overall treatment effect in their target populations.[1][2]
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.[1] The intervention list shows oral SEVABERTINIB tablet strengths of 30 mg and 40 mg.[1]
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.[2] The intervention list includes oral SEVABERTINIB and comparison medicines used in standard care.[2]
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.[1][2]
Key patient terms
Interventional study means researchers give a treatment and track what happens.[1][2] Authorised means the study has been approved to move forward.[1][2]
Enrollment is the number of people the study plans to include.[1][2] Primary outcome is the main result the trial is designed to measure.[1][2]
