Beamion LUNG-2 Trial

A study to test whether zongertinib (BI 1810631) helps people with advanced non-small cell lung cancer with HER2 mutations compared with standard treatment

The Beamion LUNG-2 trial is now enrolling patients who have unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harbouring HER2 TKD mutations. This is a phase 3, open label, randomized, active-controlled study evaluating orally administered zongertinib compared with standard of care as first-line treatment.

Patients may be eligible to participate if they:

• Are 18 years of age or older

• Histologically or cytologically confirmed diagnosis of an advanced and/or metastatic non-squamous NSCLC

• Documented HER2 mutation in the tyrosine kinase domain (TKD) as per local lab results

• Have not received any systemic treatment for locally advanced or metastatic disease

• Have at least one measurable lesion according to RECIST 1.1

• Meet additional criteria