BI 1810631
Sponsors
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A., Boehringer Ingelheim International GmbH, HUS-yhtymae
Conditions
CancerHER2-mutated or overexpressed/amplified solid tumoursNon-small cell lung canceresophageal adenocarcinomagastroesophageal junction adenocarcinomalocally advanced or metastatic NSCLCmetastatic breast cancermetastatic gastric adenocarcinoma
Phase 1
Phase 2
Beamion PANTUMOR-1: A Phase II, multicentre, multicohort, open-label trial to evaluate the efficacy and safety of oral zongertinib (BI 1810631) for the treatment of selected HER2-mutated or overexpressed/amplified solid tumours
RecruitingCTIS2023-510429-14-00
Start: 2024-10-22Target: 108Updated: 2025-12-05
FINACCESS - Finnish National Study for Early Access to Cancer Therapies
Not yet recruitingCTIS2025-524769-26-00
Target: 1500Updated: 2026-05-11
Beamion 44: A randomized, open-label, multi-center Phase IIa platform trial to evaluate the safety and tolerability of zongertinib plus Pt-doublet with or without pembrolizumab (and potential other combinations) in treatment-naïve patients with locally advanced/metastatic non-squamous NSCLC with activating HER2 mutations
Not yet recruitingCTIS2025-523567-38-00
Target: 11Updated: 2026-05-19
Phase 3
BEAMION Lung-2: A Phase III, open-label, randomized, activecontrolled, multi-centre trial evaluating orally administered zongertinib (BI 1810631) compared with standard of care as first-line treatment in patients with unresectable, locally advanced or metastatic nonsquamous non-small cell lung cancer harbouring HER2 tyrosine kinase domain mutations
RecruitingCTIS2023-504308-27-00
Start: 2024-06-06Target: 121Updated: 2025-11-13
Beamion LUNG-3: A randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable non-small cell lung cancer (Stage II-IIIB) harboring tyrosine kinase domain activating HER2 mutations
Not yet recruitingCTIS2025-521284-12-00
Target: 93Updated: 2026-01-26