Expanded Access to Provide Sevabertinib (BAY 2927088) for the Treatment of Locally Advanced or Metastatic NSCLC With HER2 Mutation

Inclusion Criteria * Signed and dated written informed consent * Age ≥18 years * Histologically or cytologically confirmed locally advanced or metastatic NSCLC * Documented disease progression after treatment with at least one prior systemic therapy for advanced disease * Documented HER2 activating mutation * Expected minimum life expectancy of 12 weeks * Performance status of 0 or 1 * Participants must be able to take oral medication * Blood test results within certain ranges * Adequate coagulation as assessed by lab tests or on stable anticoagulation treatment * Adequate cardiac function * Negative serum pregnancy test in women of childbearing potential within 72 hours of the first dose * Ability to receive prescription of loperamide from the treating physician Exclusion Criteria * Investigational agent or anticancer therapy within 2 weeks prior to planned start of sevabertinib or 5 half-lives, whichever is shorter, and without recovery of clinically significant toxicities from that therapy * Prior progression while receiving approved or investigational tyrosine kinase inhibitors targeting HER2 * Symptomatic or unstable brain metastases * Treatment with immunotherapy ≤ 28 days prior to the first dose of IMP * Past medical history of Grade ≥2 ILD, drug-induced interstitial lung disease * Inability to discontinue treatment with a strong CYP3A4 inhibitor or inducer prior to start of treatment initiation * Any uncontrolled intercurrent illness or condition including, but not…