News - HER-2 mutation

Clinical Study of SHR-A1811 Combined With Pertuzumab as Second-Line Therapy in Patients With HER2-Altered Advanced NSCLC (clinicaltrials.gov)

P=N/A, N=60, Not yet recruiting, The First Affiliated Hospital of Guangzhou Medical University

1 day ago

New trial

HER-2 (Human epidermal growth factor receptor 2)

HER-2 overexpression • HER-2 amplification • HER-2 mutation

Perjeta (pertuzumab) • trastuzumab rezetecan (SHR-A1811)

Trastuzumab rezetecan alone or in combination with adebrelimab in advanced solid tumors with HER2 expression or mutation: a prospective, multicenter, open, nonrandomized, multicohort study. (ChiCTR2500113763)

P=N/A, N=200, Not yet recruiting, The Affiliated Hospital of Xuzhou Medical University; The Affiliated Hospital of Xuzhou Medical University

3 days ago

New trial

HER-2 (Human epidermal growth factor receptor 2)

HER-2 mutation • HER-2 expression

Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811) • AiRuiLi (adebrelimab)

SHR-A1811 plus QL1706 versus standard therapy as first-line treatment for locally advanced or metastatic HER2-overexpressing non-small cell lung cancer: an open-label, single-arm, phase II clinical trial (ChiCTR2500114106)

P2, N=39, Not yet recruiting, Shanghai Pulmonary Hospital; Shanghai Pulmonary Hospital

3 days ago

New P2 trial

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)

HER-2 positive • EGFR mutation • HER-2 overexpression • HER-2 mutation • ALK mutation • HER-2 positive + HER-2 overexpression

trastuzumab rezetecan (SHR-A1811) • Qibeian (iparomlimab/tuvonralimab)

Trastuzumab rezetecan (SHR-A1811) combined with bevacizumab in previously treated HER2-altered non-small-cell lung cancer: a phase 2, single-arm study. (ChiCTR2500113565)

P2, N=60, Not yet recruiting, Cancer Hospital Chinese Academy of Medical Science; Cancer Hospital Chinese Academy of Medical Sciences

3 days ago

New P2 trial

HER-2 (Human epidermal growth factor receptor 2)

HER-2 overexpression • HER-2 amplification • HER-2 mutation

Avastin (bevacizumab) • Herceptin (trastuzumab) • trastuzumab rezetecan (SHR-A1811)

Glumetinib combined with platinum-based chemotherapy for the treatment of MET-overexpressing locally advanced or metastatic non-small cell lung cancer: A single-arm, multicenter study (ChiCTR2600117342)

P1, N=48, Not yet recruiting, West China Hospital of Sichuan University; West China Hospital of Sichuan University

3 days ago

New P1 trial

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)

EGFR mutation • BRAF mutation • BRAF V600 • HER-2 mutation • RET fusion • MET overexpression • HER-2 exon 20 insertion • ALK fusion • RET mutation • ROS1 fusion • MET mutation • NTRK fusion

carboplatin • pemetrexed • Haiyitan (gumarontinib)

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1) (clinicaltrials.gov)

P1/2, N=315, Active, not recruiting, Dizal Pharmaceuticals | Trial completion date: Dec 2025 --> Dec 2026

4 days ago

Trial completion date

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)

EGFR mutation • HER-2 mutation • EGFR exon 20 insertion • EGFR exon 20 mutation

Zegfrovy (sunvozertinib)

Trastuzumab Deruxtecan in Non-Breast Solid Tumors: Expanding Indications, Efficacy, and Future Directions. (PubMed, Crit Rev Oncol Hematol)

T-DXd has emerged as a transformative therapy across HER2-driven malignancies, leading to histology-specific and tissue-agnostic approvals. Vigilant ILD monitoring is essential, and further research is warranted to refine biomarkers, address resistance, and explore rational drug combinations. T-DXd exemplifies the paradigm shift of antibody-drug conjugates toward pan-cancer precision oncology.

4 days ago

Review • Journal

HER-2 (Human epidermal growth factor receptor 2)

HER-2 amplification • HER-2 mutation

Enhertu (fam-trastuzumab deruxtecan-nxki)

Prognostic Impact of RTK-RAS Alterations in FOLFOX-Treated Early-Onset Colorectal Cancer Revealed by Artificial Intelligence-Driven Precision Oncology. (PubMed, Cancers (Basel))

RTK-RAS pathway alterations demonstrate strong age-, ancestry-, and treatment-specific prognostic effects and may serve as precision biomarkers of differential chemotherapy response. AI-enabled analytics substantially accelerated integrative biomarker discovery, supporting their utility for advancing precision oncology in EOCRC.

6 days ago

Journal

HER-2 (Human epidermal growth factor receptor 2) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NF1 (Neurofibromin 1) • ERRFI1 (ERBB Receptor Feedback Inhibitor 1) • MAPK3 (Mitogen-Activated Protein Kinase 3)

KRAS mutation • HER-2 mutation

5-fluorouracil • leucovorin calcium

NCI 10495: Testing the Safety and Tolerability of the Anti-cancer Drugs Trastuzumab Deruxtecan and Neratinib for Cancers With Changes in the HER2 Gene (clinicaltrials.gov)

P1, N=33, Suspended, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jan 2027 | Recruiting --> Suspended

6 days ago

Trial completion date • Trial suspension

CD4 (CD4 Molecule)

HER-2 positive • HER-2 overexpression • HER-2 amplification • HER-2 mutation

Nerlynx (neratinib) • Enhertu (fam-trastuzumab deruxtecan-nxki)

10d

Summary and Analysis of Molecular Biological Changes, PD-L1 Immune Status and Clinicopathological Features of 78 Cases of Papillary Thyroid Carcinoma (<1 cm in Diameter) Combined With Lateral Cervical Lymph Node Metastasis. (PubMed, Appl Immunohistochem Mol Morphol)

Among them, patients with BRAF and K-RAS gene mutations are usually accompanied by positive expression of ER and PR, suggesting that these patients may benefit from endocrine therapy. In addition, PD-L1-mediated immunotherapy has broad application prospects in this tumor, female patients may benefit more, and immunotherapy combined with endocrine therapy is expected to become a good adjuvant treatment option for female cases.

10 days ago

Journal • PD(L)-1 Biomarker • IO biomarker

PD-L1 (Programmed death ligand 1) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • RET (Ret Proto-Oncogene) • TERT (Telomerase Reverse Transcriptase)

PD-L1 expression • KRAS mutation • BRAF mutation • NRAS mutation • PIK3CA mutation • HER-2 mutation • BRAF wild-type • RAS mutation • RET mutation

10d

A Study of a Selective ERBB2 Inhibitor (CGT4255), in Patients With Advanced Solid Tumors (clinicaltrials.gov)

P1, N=100, Recruiting, Cogent Biosciences, Inc.

10 days ago

New P1 trial

HER-2 (Human epidermal growth factor receptor 2) • NRG1 (Neuregulin 1)

HER-2 overexpression • HER-2 mutation • NRG1 fusion

10d

LUNG-MAP SUB-STUDY: Targeted Treatment for Advanced Non-Small Cell Lung Cancer That Has a MET Exon 14 Skipping Gene Change (An Expanded Lung-MAP Treatment Trial) (clinicaltrials.gov)

P2, N=56, Recruiting, SWOG Cancer Research Network | Trial completion date: May 2029 --> May 2028

10 days ago

Trial completion date

EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)

BRAF V600E • KRAS mutation • EGFR mutation • BRAF V600 • HER-2 mutation • EGFR T790M • MET exon 14 mutation • ALK fusion • ROS1 fusion • RET rearrangement

Cyramza (ramucirumab) • Tepmetko (tepotinib)