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