A 63-year-old Japanese woman with stage IVB lung adenocarcinoma [programmed death ligand-1 (PD-L1) tumor proportion score 70%] received multiple lines of systemic therapy, including pembrolizumab-based chemoimmunotherapy, docetaxel plus ramucirumab, and subsequent cytotoxic regimens. The A763_Y764insFQEA mutation is uniquely sensitive to EGFR-TKIs, and comprehensive molecular testing can guide effective targeted therapy even in later treatment lines. Broader implementation of hybrid-capture-based assays may improve precision oncology outcomes for patients with rare EGFR alterations.

2 days ago

Journal • PD(L)-1 Biomarker • IO biomarker • Circulating tumor DNA

EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1)

EGFR mutation • EGFR exon 20 insertion • EGFR A763_Y764insFQEA • EGFR exon 20 mutation

FoundationOne® Liquid CDx

Keytruda (pembrolizumab) • Tagrisso (osimertinib) • docetaxel • Cyramza (ramucirumab) • simmitinib (SYHA1817)

AMICUTE: Phase II Trial of Amivantamab Plus Monochemotherapy in Platinum Unfit NSCLC Patients With EGFR exon20 Insertion Mutations. (clinicaltrials.gov)

P2, N=33, Recruiting, Fondazione Ricerca Traslazionale

5 days ago

New P2 trial

EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation

10d

Preclinical to clinical translation of pharmacokinetic-pharmacodynamic relationship in EGFR Exon20Ins mutations: a modelling framework for irreversible inhibitors. (PubMed, Mol Cancer Ther)

We also explored clinical phosEGFR reduction induced by the 3rd generation TKI osimertinib, suggesting that limited target engagement may explain modest response achieved in EGFR Exon20Ins at the clinically investigated doses. The developed model is a valuable tool to understand the impact of kinetic characteristics on phosEGFR reduction and related efficacy, select a target engagement-based criterion for therapeutic dose predictions, and provide interpretation and insights on observed clinical efficacy of irreversible inhibitors in EGFR Exon20Ins.

10 days ago

PK/PD data • Preclinical • Journal

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation

Tagrisso (osimertinib) • simmitinib (SYHA1817)

11d

An open-label, multicenter, phase Ib/II clinical study to evaluate the safety, efficacy and pharmacokinetic characteristics of PLB1004 capsules in combination with platinum-based doublet chemotherapy in subjects with EGFR mutation-positive non-small cell lung cancer. (ChiCTR2500105771)

P1/2, N=108, Recruiting, Shanghai Chest Hospital; Avistone Pharmaceutical(Ningbo)Co., LTD. | Not yet recruiting --> Recruiting

11 days ago

Enrollment open

EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation

andamertinib (PLB1004)

13d

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

13 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)

15d

NCI-2017-00831: Poziotinib in EGFR Exon 20 Mutant Advanced NSCLC (clinicaltrials.gov)

P2, N=93, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Dec 2027

15 days ago

Trial completion date • Trial primary completion date

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

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

FoundationOne® CDx • Guardant360® CDx • cobas® EGFR Mutation Test v2 • therascreen® EGFR RGQ PCR Kit

Pozenveo (poziotinib)

15d

Inverted Sinonasal Papilloma: Pheno-endotyping and Predictive Markers of Recurrence and Malignancy - A Systematic Review. (PubMed, Curr Allergy Asthma Rep)

SNIP exhibits multifactorial biological behavior driven by inflammation, viral infection, and molecular dysregulation. These findings highlight the need for standardized histopathological and molecular criteria and prospective studies to refine recurrence prediction and early detection of malignant transformation.

15 days ago

Review • Journal

EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53)

TP53 mutation • EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation

16d

Prolonged survival in EGFR exon 20 insertion mutant lung adenocarcinoma: case report of sequential osimertinib and furmonertinib with research trend analysis. (PubMed, Front Med (Lausanne))

This analysis demonstrated a growing global research focus on third-generation EGFR-TKIs and variant-specific treatment strategies for EGFR ex20ins-mutant NSCLC, supporting the rationale underpinning the therapeutic approach adopted in this report. Sequential high-dose third-generation EGFR-TKIs may offer clinically meaningful benefit in selected EGFR ex20ins cases; however, this strategy remains non-standard and should be regarded as hypothesis-generating, warranting further prospective evaluation.

16 days ago

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

EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • TP53 (Tumor protein P53) • ETV6 (ETS Variant Transcription Factor 6) • SMAD4 (SMAD family member 4) • SETD2 (SET Domain Containing 2, Histone Lysine Methyltransferase)

PD-L1 expression • TP53 mutation • EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation

Tagrisso (osimertinib) • Ivesa (firmonertinib) • simmitinib (SYHA1817)

19d

Furmonertinib in lung adenocarcinoma with EGFR exon 20 insertion mutation: A case report of positive outcome. (PubMed, Medicine (Baltimore))

Furmonertinib, as a third-generation EGFR-TKI, demonstrated substantial efficacy in patients with advanced EGFR20ins-mutant NSCLC, significantly extending PFS and improving quality of life. This drug offers a promising new treatment option for patients with resistance to conventional therapies. Further studies will help validate the application of furmonertinib in a broader patient population.

19 days ago

Journal

EGFR (Epidermal growth factor receptor)

EGFR mutation • EGFR exon 20 insertion • EGFR exon 20 mutation

Ivesa (firmonertinib)

26d

Study of EGF816 in Combination With Selected Targeted Agents in EGFR-mutant NSCLC (clinicaltrials.gov)

P1, N=105, Active, not recruiting, Novartis Pharmaceuticals | Trial completion date: Mar 2026 --> Oct 2026 | Trial primary completion date: Mar 2026 --> Oct 2026

26 days ago

Trial completion date • Trial primary completion date

EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • EGFR exon 20 mutation

Mekinist (trametinib) • gefitinib • Kisqali (ribociclib) • Tabrecta (capmatinib) • naporafenib (ERAS-254) • nazartinib (EGF816)

First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations (clinicaltrials.gov)

P1/2, N=251, Recruiting, Pierre Fabre Medicament | N=185 --> 251 | Trial completion date: Jun 2028 --> Dec 2029 | Trial primary completion date: Jun 2027 --> Dec 2029

1 month ago

Enrollment change • Trial completion date • Trial primary completion date • First-in-human

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

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

STX-721

Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer (clinicaltrials.gov)

P2, N=60, Not yet recruiting, Jonsson Comprehensive Cancer Center

1 month ago

New P2 trial

MET (MET proto-oncogene, receptor tyrosine kinase)

EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M • EGFR exon 20 insertion • MET overexpression • EGFR exon 20 mutation

CONFIRM anti-Total c-MET (SP44) Rabbit Monoclonal Primary Antibody • VENTANA® MET (SP44) RxDx Assay

Tagrisso (osimertinib) • Emrelis (telisotuzumab vedotin-tllv) • simmitinib (SYHA1817)