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A study to test zongertinib monotherapy in patients with HER2-altered advanced or metastatic solid tumors (Phase Ia) and HER2-mutant advanced or metastatic NSCLC (Phase Ib) (NCT04886804)1–3

zongertinib: NCT04886804 (Beamion™ LUNG-1, 1479-0001)
zongertinib: NCT04886804 (Beamion™ LUNG-1, 1479-0001)

*Randomized to receive either 240 mg or 120 mg QD. One dose will be selected after interim analysis; †Excluding patients pretreated with ADCs.
ADC, antibody–drug conjugate; BID, twice daily; DLT, dose-limiting toxicity; HER2, human epidermal growth factor receptor 2; MTD, maximum tolerated dose; NRG1, neuregulin 1; NSCLC, non-small cell lung cancer; OR, objective response; QD, once daily; RECIST, Response Evaluation Criteria in Solid Tumours; TKD, tyrosine kinase domain.
 

References

  1. Heymach J, et al. J Clin Oncol 2025;43:1337–1347.

  2. Heymach JV, et al. N Engl J Med 2025;392(23):2321–2333.

  3. ClinicalTrials.gov. NCT04886804. https://clinicaltrials.gov/ct2/show/study/NCT04886804 (Accessed: August 2025).