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Study 22615

A Phase 3 study of BAY 2927088 compared to standard treatment in advanced non-small cell lung cancer (NSCLC) with HER2 mutations. Study 22615 ("SOHO-02")

The researchers are looking for a better treatment for people suffering from advanced lung cancer that has certain specific genetic changes ("HER2 mutation"). Advanced non-small cell lung cancer (NSCLC) is a group of lung cancers that have already spread to nearby tissues outside the lungs or to other parts of the body. The likelihood of curing or controlling this with available therapy is low. HER2 is a protein that promotes the growth and spread of cells. If it is genetically modified, the modified HER2 promotes this even more. We expect BAY 2927088 to block the altered HER2, which should stop the spread of lung cancer. The main purpose of this study is to investigate how well BAY 2927088 works and how safe it is compared to standard therapy in patients with advanced NSCLC with HER2 gene alterations (mutations). Patients will receive either BAY 2927088 as tablets twice daily, or standard therapy administered by infusion into the veins, in cycles of 21 days. The therapy will be continued as long as the patients benefit from the therapy and have no severe side effects or until the treating physician or the patient decides to discontinue the therapy. During the course of the study, images are also taken using computer tomography, magnetic resonance therapy, PET scanner or X-ray. In addition, general health is monitored, blood and urine tests are carried out and cardiac activity is checked with an ECG. Patients also have to complete questionnaires.

Advanced non-small cell lung cancer || HER2 mutation | Study 22615 | Bayer - Clinical Trials Explorer

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