ASCO 2025: SOHO-02 Trial to Investigate BAY 2927088 as Frontline Treatment for HER2-Positive NSCLC

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Published Jul 13, 2025

Xiuning Le, MD, PhD, of the University of Texas MD Anderson Cancer Center, joined Lung Cancers Today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting to discuss the SOHO-02 trial.
The phase 3 trial is evaluating BAY 2927088 in patients who have locally advanced or metastatic non–small cell lung cancer (NSCLC) with HER2-activating mutations. The study follows the SOHO-01 trial, which evaluated the oral tyrosine kinase inhibitor in patients with previously treated NSCLC with HER2-activating mutations.
“Initially we started with dose escalation and dose expansion based on the SOHO-01 data, [and] we observed fantastic treatment efficacy,” Dr. Le said.
She explained that due to the “impressive efficacy” of BAY 2927088 and the high level of unmet need for this population of patients with locally advanced or metastatic NSCLC with HER2-activating mutations, they began the randomized global phase 3 SOHO-02 trial. The trial will randomize treatment-naive patients to receive BAY 2927088 or standard-of-care chemoimmunotherapy.
“We look forward to enrolling patients from all continents and then testing if the HER2-targeted therapy can be superior to what we're using now,” Dr. Le explained.