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Zongertinib (HERNEXEOS)

Boehringer Ingelheim

Selective HER2 TKI. FDA accelerated approval August 2025 (2L) and February 2026 (1L). Beamion LUNG-2 Phase 3 (1L HER2-mutant NSCLC vs SoC) is the confirmatory trial; enrollment complete. OS readout is the key remaining catalyst.

NSCLCHER2-mutant

Linked Studies

NCT06151574PrimaryACTIVE_NOT_RECRUITINGPHASE3

Beamion LUNG-2: A Study to Test Whether Zongertinib (BI 1810631) Helps People With Advanced Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment

Lung Cancer, Non-squamous, Non-small CellUpdated May 2026
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Other names

zongertinib
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