M.D. Anderson Cancer Center
This is a Phase Ia/Ib, open-label study evaluating the concurrent administration of zanidatamab and zongertinib in patients with advanced, unresectable, or metastatic non-small lung cancer harboring HER2 alterations.
Primary Objectives: The primary objective of the study is to evaluate safety and tolerability of zongertinib in combination with zanidatamab in patients with HER2-mutant NSCLC. The co-primary endpoints will be the incidence of DLTs during the first 21 days in Part 1 (safety lead-in) to determine the recommended dose of zongertinib in combination with zanidatamab; and the incidence of Treatment-Emergent Adverse Events (TEAEs) during the entire treatment period of the study (part 1 and 2) Secondary Objectives: * Determine the confirmed objective response rate (ORR) as per RECIST v1.1 with za…
Inclusion Criteria: 1. Age ≥ 18 years at the time of consent. 2. Histologically or cytologically confirmed diagnosis of an advanced, unresectable and/or metastatic non-small cell lung cancer (NSCLC). 3. Baseline archival tumor tissue available, either from primary or metastatic sites. If archival material is not available, a fresh tumor biopsy should be performed if feasible and if the procedure poses no significant risk for the participant. 4. Next generation sequencing (NGS) test documenting activating HER2 mutation in the tyrosine kinase domain assessed by a Clinical Laboratory Improvement…
Given by intravenous infusion
Given by mouth
Arctuva estimate
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