EGFR exon 20 insertion

P2, N=520, Recruiting, Janssen Research & Development, LLC | Trial completion date: Aug 2027 --> Aug 2028

Amivantamab-chemotherapy demonstrated superior PFS vs chemotherapy and represents a new standard of care for first-line treatment of Asian participants with Ex20ins-mutated NSCLC.

Amivantamab plus chemotherapy significantly delays symptomatic progression without compromising health-related quality of life, reinforcing its role as a first-line treatment for Ex20ins-mutated NSCLC.

After multi-disciplinary treatment, the patient received concurrent chemoradiotherapy with pemetrexed and cisplatin, and achieved partial response. This patient did not receive durvalumab immunoconsolidation therapy for economic reasons...Patients with EGFR S768I/V769L compound mutated NSCLC may benefit from afatinib and osimertinib. Drugs with strong brain penetration capabilities are still needed for patients with S768I/V769L compound mutation to further improve survival outcomes.

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.

P2, N=33, Recruiting, Fondazione Ricerca Traslazionale

Here, we describe a case of early-stage non-small cell lung cancer (NSCLC) harboring a G719C+S768I compound mutation that achieved complete remission following treatment with furmonertinib. These findings suggest that furmonertinib may represent a promising therapeutic option to improve cure rates in this subset of patients.

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.

P1, N=36, Not yet recruiting, Shanghai East Hospital; Jing Medicine Technology (Shanghai) Co., Ltd.

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

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

The gold nanoparticle-assisted wash method has enhanced differentiation between WT and mutated sequences relevant to the EGFR sensitivity to tyrosine kinase inhibitors. The WT and mutated sequences (T790M, L858R and L861Q) in genomic samples were successfully differentiated from each other.