Zongertinib Evidence: Trial Results and Peer-Reviewed Publications

Hipa.ai Research · Source: PubMed & ClinicalTrials.gov / AACT · Last updated:

The clinical evidence base for Zongertinib comprises 7 peer-reviewed publications across 5 journals, 0 pivotal-trial primary-outcome rows reported to ClinicalTrials.gov, spanning indications including Carcinoma, Non-Small-Cell Lung, and Adenocarcinoma Of Esophagus. Most recent publication: Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or HER2-mutant solid tumors., Future Oncol, 2026.

Top peer-reviewed publications

Curated set of pivotal-trial result papers and recent publications in high-tier journals.

  1. Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or HER2-mutant solid tumors.
    Schram AM, Park JJ, Italiano A, et al. · Future Oncol · 2026
    PubMed: PMID 41777164 · NCT06581432
  2. Beamion BCGC-1: phase Ib/II trial of zongertinib for advanced HER2-positive breast or gastroesophageal cancers.
    Hurvitz S, Simonelli M, Yarza R, et al. · Future Oncol · 2025
    PubMed: PMID 41108088 · NCT06324357 · Adenocarcinoma Of Esophagus
  3. First-Line Zongertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer.
    Heymach JV, Yamamoto N, Girard N, et al. · N Engl J Med · 2026
    PubMed: PMID 41985129 · NCT04886804 · Carcinoma, Non-Small-Cell Lung
  4. Zongertinib in Previously Treated HER2-Mutant Non-Small-Cell Lung Cancer.
    Heymach JV, Ruiter G, Ahn MJ, et al. · N Engl J Med · 2025
    PubMed: PMID 40293180 · NCT04886804 · Carcinoma, Non-Small-Cell Lung
  5. HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors With HER2 Alterations: A Phase Ia Dose-Escalation Study.
    Heymach JV, Opdam F, Barve M, et al. · J Clin Oncol · 2025
    PubMed: PMID 40030100 · NCT04886804 · Carcinoma, Non-Small-Cell Lung
  6. A Phase I, Open-Label, Dose Confirmation, Escalation, and Expansion Trial of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations.
    Heymach J, Opdam F, Barve M, et al. · Clin Lung Cancer · 2023
    PubMed: PMID 36528522 · NCT04886804 · Carcinoma, Non-Small-Cell Lung
  7. Absorption, Metabolism, Distribution and Excretion (ADME) and Absolute Bioavailability Assessment of Zongertinib in Healthy Male Volunteers.
    Grempler R, Joseph D, Gan G, et al. · Clin Drug Investig · 2026
    PubMed: PMID 41348300 · NCT05879991

Publications by year

2023–2026: 7 publications.

2023
1
2025
3
2026
3

Publications by indication

Carcinoma, Non-Small-Cell Lung (4)

  • First-Line Zongertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer.
    N Engl J Med · 2026 · PMID 41985129 · NCT04886804
  • Zongertinib in Previously Treated HER2-Mutant Non-Small-Cell Lung Cancer.
    N Engl J Med · 2025 · PMID 40293180 · NCT04886804
  • HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors With HER2 Alterations: A Phase Ia Dose-Escalation Study.
    J Clin Oncol · 2025 · PMID 40030100 · NCT04886804
  • A Phase I, Open-Label, Dose Confirmation, Escalation, and Expansion Trial of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations.
    Clin Lung Cancer · 2023 · PMID 36528522 · NCT04886804

Adenocarcinoma Of Esophagus (1)

  • Beamion BCGC-1: phase Ib/II trial of zongertinib for advanced HER2-positive breast or gastroesophageal cancers.
    Future Oncol · 2025 · PMID 41108088 · NCT06324357

Publications by journal

  • Future Oncol2 papers
  • N Engl J Med2 papers
  • J Clin Oncol1 paper
  • Clin Lung Cancer1 paper
  • Clin Drug Investig1 paper

All Zongertinib publications (7)

2026 (3 papers)

  1. Beamion PANTUMOR-1: rationale and design of a Phase II trial of zongertinib in HER2-overexpressed/amplified or HER2-mutant solid tumors.
    Schram AM, Park JJ, Italiano A, et al. · Future Oncol · 2026 · Derived
    PubMed: PMID 41777164 · NCT06581432
  2. First-Line Zongertinib in Advanced HER2-Mutant Non-Small-Cell Lung Cancer.
    Heymach JV, Yamamoto N, Girard N, et al. · N Engl J Med · 2026 · Derived
    PubMed: PMID 41985129 · NCT04886804 · Carcinoma, Non-Small-Cell Lung
  3. Absorption, Metabolism, Distribution and Excretion (ADME) and Absolute Bioavailability Assessment of Zongertinib in Healthy Male Volunteers.
    Grempler R, Joseph D, Gan G, et al. · Clin Drug Investig · 2026 · Derived
    PubMed: PMID 41348300 · NCT05879991

2025 (3 papers)

  1. Beamion BCGC-1: phase Ib/II trial of zongertinib for advanced HER2-positive breast or gastroesophageal cancers.
    Hurvitz S, Simonelli M, Yarza R, et al. · Future Oncol · 2025 · Derived
    PubMed: PMID 41108088 · NCT06324357 · Adenocarcinoma Of Esophagus
  2. Zongertinib in Previously Treated HER2-Mutant Non-Small-Cell Lung Cancer.
    Heymach JV, Ruiter G, Ahn MJ, et al. · N Engl J Med · 2025 · Derived
    PubMed: PMID 40293180 · NCT04886804 · Carcinoma, Non-Small-Cell Lung
  3. HER2-Selective Tyrosine Kinase Inhibitor, Zongertinib (BI 1810631), in Patients With Advanced/Metastatic Solid Tumors With HER2 Alterations: A Phase Ia Dose-Escalation Study.
    Heymach JV, Opdam F, Barve M, et al. · J Clin Oncol · 2025 · Derived
    PubMed: PMID 40030100 · NCT04886804 · Carcinoma, Non-Small-Cell Lung

2023 (1 paper)

  1. A Phase I, Open-Label, Dose Confirmation, Escalation, and Expansion Trial of BI 1810631 as Monotherapy in Patients With Advanced or Metastatic Solid Tumors With HER2 Aberrations.
    Heymach J, Opdam F, Barve M, et al. · Clin Lung Cancer · 2023 · Derived
    PubMed: PMID 36528522 · NCT04886804 · Carcinoma, Non-Small-Cell Lung

Sources and methodology

  • Publications: ctgov.study_references (PubMed PMIDs auto-attached by ClinicalTrials.gov to each trial), reference types RESULT, DERIVED, and BACKGROUND.
  • Per-arm outcome values: ctgov.outcome_measurements joined to ctgov.design_outcomes where outcome_type = 'PRIMARY', restricted to phase PHASE3 and PHASE2/PHASE3.
  • Publication metadata (title, journal, year, authors): PubMed E-utilities efetch.fcgi
  • Data freshness: Fri, 17 Jul 2026 04:01:43 GMT.
This page summarizes published evidence for general reference and does not constitute medical advice. For clinical decisions, consult the linked primary publications and your healthcare provider. Data sourced from PubMed and the ClinicalTrials.gov / AACT database maintained by the Clinical Trials Transformation Initiative (CTTI).