Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations

Inclusion Criteria

• •Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic solid tumor, including primary brain tumors
• •Participants with non-squamous NSCLC must have progressed during or after standard treatment or for which no standard treatment is available
• •Participants with other disease types must have progressed during or after ≥1 prior line of systemic therapy for locally-advanced unresectable or metastatic disease
• •Disease progression during or after, or intolerance of, the most recent line of systemic therapy
• •Disease demonstrating HER2 alterations (overexpression/amplification or HER2 activating mutations), as determined by local or central testing processed in a Clinical Laboratory Improvement Amendments (CLIA)- or International Organization for Standardization (ISO) accredited laboratory, according to one of the following:
• •* HER2 overexpression/amplification from fresh or archival tumor tissue or blood
• •* Known activating HER2 mutations detected in fresh or archival tumor tissue or blood
• •Have measurable disease per RECIST v1.1 criteria according to investigator assessment
• •Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1