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Association details:
| Biomarker: | HER-2 mutation |
|---|---|
| Cancer: | Non Small Cell Lung Cancer |
| Drug: | zongertinib (BI 1810631) (HER2 exon 20 mutation inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
A Study to Test Different Doses of Zongertinib in People With Different Types of Advanced Cancer (Solid Tumours With Changes in the HER2 Gene)
Excerpt:
...- Non-squamous non-small cell lung cancer (NSCLC) patients with documented human epidermal growth factor receptor 2 (HER2) mutation in the tyrosine kinase domain (TKD) as per local lab results....
Trial ID:
Source:
Title:
1375P - Beamion Lung 1, an ongoing phase Ia/Ib trial of the HER2 TKI, BI 1810631 in patients (pts) with advanced solid tumors with HER2 aberrations: Latest data
Published date:
10/16/2023
Excerpt:
The ongoing phase Ia/Ib trial determines the safety, MTD, PK, PD and preliminary efficacy of BI 1810631 in pts with HER2 aberration-positive solid tumors (NCT04886804)....Of 24 evaluable lung cancer patients (17 are still on Tx), 11 responded (all PRs) and 12 had SD. Two patients with other tumors (esophagus; cholangiocarcinoma) also achieved PR.
Trial ID:
Source:
Title:
A Phase 1 Trial of BI 1810631, a HER2 Tyrosine Kinase Inhibitor (TKI), as Monotherapy in Patients with Advanced/Metastatic Solid Tumors with HER2 Aberrations
Published date:
01/28/2023
Excerpt:
This phase 1a/1b, open-label, non-randomized study aims to determine...preliminary efficacy of BI 1810631 in patients with HER2 aberration-positive solid tumors (NCT04886804)…. In 23 patients evaluable for response the overall response rate (ORR) was 39% (n=9; NSCLC: n=7; esophagus, cholangiocarcinoma: n=1). The disease control rate (DCR) was 83%. In 14 patients with NSCLC with HER2 mutation evaluable for response, the ORR was 50% and the DCR was 93%.
Trial ID:
