Therapy Detail
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| Therapy Name | Zongertinib |
| Synonyms | |
| Therapy Description |
Hernexeos (zongertinib) is an ERBB2 (HER2) selective inhibitor with potential anti-tumor activity (J of Clin Oncol 40, no. 16_suppl (June 01, 2022) TPS9143, PMID: 36528522). Hernexeos (zongertinib) is FDA-approved for use in patients with unresectable or metastatic non-squamous non-small cell lung cancer harboring ERBB2 (HER2) tyrosine kinase domain activating mutations (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Zongertinib | Hernexeos | BI-1810631|BI1810631|BI 1810631 | HER2 Inhibitor 44 | Hernexeos (zongertinib) is an ERBB2 (HER2) selective inhibitor with potential anti-tumor activity (J of Clin Oncol 40, no. 16_suppl (June 01, 2022) TPS9143, PMID: 36528522). Hernexeos (zongertinib) is FDA-approved for use in patients with unresectable or metastatic non-squamous non-small cell lung cancer harboring ERBB2 (HER2) tyrosine kinase domain activating mutations (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT06151574 | Phase III | Cisplatin + Pembrolizumab + Pemetrexed Disodium Carboplatin + Pembrolizumab + Pemetrexed Disodium Zongertinib | 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 | Recruiting | USA | SWE | POL | NOR | NLD | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CAN | BRA | BEL | AUT | AUS | ARG | 10 |
| NCT06581432 | Phase II | Zongertinib | Beamion PANTUMOR-1: A Study to Test Whether Zongertinib Helps People With Advanced Cancers With HER2 Alterations | Recruiting | USA | NOR | NLD | ITA | FRA | ESP | DEU | CAN | BEL | AUS | 4 |
| NCT04886804 | Phase I | Zongertinib | Beamion LUNG-1: A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene) | Recruiting | USA | SWE | NLD | ITA | ISR | GBR | FRA | ESP | DEU | BEL | AUT | AUS | 6 |
| NCT07195695 | Phase III | Durvalumab Zongertinib Pembrolizumab Atezolizumab Nivolumab | Beamion LUNG-3: A Study to Test Whether Zongertinib Helps People With Surgically Removed, Non-small Cell Lung Cancer With HER2 Mutations Compared With Standard Treatment | Not yet recruiting | USA | TUR | SWE | ROU | NLD | ITA | ISR | GRC | FRA | ESP | DNK | DEU | CAN | BRA | BEL | AUT | ARG | 9 |
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