EGFR exon 19 deletion

P=N/A, N=20, Suspended, M.D. Anderson Cancer Center

This report of a patient with the rare p.(Cys797Ala) EGFR acquired mutation highlights the role of molecular modelling and IHC for phosphorylated proteins as tools to functionally characterize variants of unknown significance and help clinical decisions.

Our study found that EGFR-TKI monotherapy and combination therapy demonstrated no significant differences in terms of DFS or OS in patients with completely resected stage N2 EGFR-mutant NSCLC. Adjuvant treatment with third-generation EGFR-TKIs and prolonged treatment duration may offer enhanced survival benefits.

P3, N=440, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting

CT-based radiological features are significantly correlated with TMB status in lung adenocarcinoma. A composite model incorporating these features demonstrates high diagnostic accuracy for identifying high TMB, offering a valuable non-invasive tool for guiding personalized treatment strategies.

In this review, we highlight a case example that illustrates key treatment considerations, including balancing efficacy, toxicity, and patient preferences when selecting the optimal palliative therapy. We discuss key treatment considerations for EGFR PACC mutated NSCLC to inform the use of afatinib (the only approved therapy with an indication that includes two EGFR PACC mutations, G719X and S768I), osimertinib, or combination therapies in the upfront setting; limitations of the available data; and ongoing clinical trials specific to the EGFR PACC mutation subgroup that may further refine our understanding of treatment for patients with these tumors.

The patient was then initiated on combination therapy with carboplatin (area under the curve 5), pemetrexed (500 mg/m2), and osimertinib (80 mg), completing six cycles. Although limited to a single case, our findings support the growing interest in combining systemic and local therapies in EGFR-mutant non-small cell lung cancer and offer a potential framework for adapting these strategies to molecularly analogous tumors. Longer-term follow-up and further studies are needed to refine patient selection and optimize treatment intensity.

To the best of our knowledge, this study represents the first evaluation of vinorelbine plus firmonertinib in EGFR-mutated locally advanced or metastatic NSCLC with M1c2 disease or elevated PD-L1 expression, aiming to provide an effective, tolerable, and convenient all-oral treatment option for this refractory population. The study protocol (version 1.2; July 18, 2025) was registered on October 24, 2025, at the Chinese Clinical Trial Registry (ChiCTR2500111096).

Concurrent palliative RT and amivantamab appears feasible and well tolerated. Further validation is warranted.

P1, N=36, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jun 2026 --> Feb 2027 | Trial primary completion date: Jun 2026 --> Feb 2027

P3, N=412, Active, not recruiting, Hutchison Medipharma Limited | Trial completion date: Aug 2026 --> May 2028 | Trial primary completion date: Aug 2026 --> May 2028

P2, N=32, Recruiting, Nanfang Hospital, Southern Medical University