Zongertinib in Phase II Lung Cancer Trial

Study Design: Participants: Approximately 270 patients with histologically or cytologically confirmed advanced or metastatic non-squamous NSCLC, possessing HER2 mutations in the tyrosine kinase domain. Randomization: Participants are randomized in a 1:1 ratio to receive either zongertinib or the standard of care. Treatment Arms: Experimental Arm: Oral zongertinib at a dose of 120 mg once daily in 21-day cycles. Control Arm: Intravenous pemetrexed (500 mg/m²) combined with either cisplatin (75 mg/m²) or carboplatin (AUC 5), plus pembrolizumab (200 mg), administered on day 1 every three weeks for four cycles. This is followed by maintenance therapy with pemetrexed and pembrolizumab every three weeks for up to 35 cycles. Endpoints: Primary Endpoint: Progression-free survival, assessed using RECIST 1.1 criteria. Secondary Endpoints: Overall response rate, overall survival, patient-reported outcomes (changes from baseline to week 25), and adverse events graded according to CTCAE 5.0. The trial aims to determine whether zongertinib offers superior efficacy compared to the current standard of care in this patient population. For more detailed information, you can refer to the study's registration on ClinicalTrials.gov under the identifier NCT06151574.