Table of contents
- Trial overview
- Who is being studied
- Trial phases and design
- Main endpoints
- Trial interventions and comparison groups
- Patient-friendly terms
Trial overview
Two authorised interventional studies are investigating 3-(3-CHLORO-2-METHOXYANILINO)-2-{3-[(2S)-1,4-DIOXAN-2-YLMETHOXY]PYRIDIN-4-YL}-1,5,6,7-TETRAHYDRO-4H-PYRROLO[3,2-C]PYRIDIN-4-ONE, which is named sevabertinib or BAY 2927088 in the trial records.[1][2] One study focuses on advanced non-small cell lung cancer with a HER2 mutation, and the other focuses on advanced solid tumors with HER2 mutations.[1][2]
The studies are designed to learn about both effectiveness and safety.[1][2] Effectiveness means how well the treatment works against the cancer, while safety means how well people tolerate it during the study.[1][2]
Who is being studied
The Phase 3 trial includes participants with advanced non-small cell lung cancer and a HER2 (ERBB2) mutation.[1] This means the study is aimed at people whose lung cancer has progressed and has a specific gene change found in the tumor.[1]
The Phase 2 trial includes participants with advanced solid tumors that have HER2 mutations.[2] Solid tumors are cancers that form a mass in an organ or tissue, and this study is not limited to one cancer type.[2]
Trial phases and design
The lung cancer study is a Phase 3 trial with 444 planned participants.[1] Phase 3 studies are usually larger and compare a study treatment with standard treatment to see which works better.[1]
The solid tumor study is a Phase 2 trial with 111 planned participants.[2] Phase 2 studies often look more closely at whether a treatment shows signs of benefit and continue to monitor safety.[2]
Both trials are listed as Authorised in the source data.[1][2]
Main endpoints
The main endpoint in the Phase 3 lung cancer study is progression-free survival (PFS) measured by RECIST 1.1 and checked by blinded independent central review.[1] PFS is the time before the cancer gets worse, and RECIST 1.1 is a standard way to measure tumor change on scans.[1]
The main endpoint in the Phase 2 solid tumor study is objective response rate (ORR) measured by RECIST 1.1 and checked by blinded independent central review.[2] ORR tells researchers how many participants have a measurable tumor response, such as tumor shrinkage.[2]
Trial interventions and comparison groups
The Phase 3 study compares sevabertinib with standard treatment in advanced HER2-mutated non-small cell lung cancer.[1] The source data lists several standard treatment drugs used in the study record, including cisplatin, pemetrexed, carboplatin, and KEYTRUDA.[1]
The Phase 2 study evaluates sevabertinib tablets in participants with HER2-mutated advanced solid tumors.[2] The source data lists oral study doses of BAY 2927088 in this trial record.[2]
Patient-friendly terms
HER2 mutation means a change in a gene that can be found in some cancers.[1][2] In these studies, the treatment is being tested in cancers with this gene change, not in all cancers.[1][2]
Blinded independent central review means scan results are checked by experts who do not know which treatment a person received.[1][2] This helps make the results more fair and reliable.[1][2]
Standard treatment means the usual care used for comparison in a clinical trial.[1] In this data set, the standard treatment arm includes chemotherapy drugs and KEYTRUDA.[1]
