EGFR exon 19 deletion

P2/3, N=410, Recruiting, Sinocelltech Ltd.

P1, N=42, Recruiting, Alpha Biopharma (Jiangsu) Co., Ltd. | Not yet recruiting --> Recruiting

We report the case of a 61-year-old woman diagnosed with stage IV lung adenocarcinoma with brain metastasis harboring an EGFR exon 19 deletion (p.E746_A750del), who acquired resistance to osimertinib through a ROS1 fusion bypass pathway. The patient achieved a survival of over 6.5 years from initial diagnosis through ongoing adjustments to targeted therapy, including sequential treatment with crizotinib, entrectinib, and lorlatinib...Notably, we observed an interesting phenomenon with both crizotinib and entrectinib: while initial treatment led to intolerable adverse reactions requiring discontinuation, subsequent reintroduction of the same agent was well-tolerated. This case report aims to provide potential treatment strategies for patients with similar complex co-mutations.

P1/2, N=32, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Jun 2026 --> Jun 2028 | Trial primary completion date: Jun 2026 --> Jun 2028

Our findings demonstrate that compound EGFR mutations comprise distinct subgroups with unique clinical characteristics and different responses to targeted therapy. For example, osimertinib may be a viable treatment for patients with compound G719X/L861Q mutations. Further characterization of these heterogeneous subgroups is warranted for identifying optimal treatment strategies as novel targeted agents emerge.

In a small-sample-size test, the ESEA system achieved 100% sensitivity and specificity in pleural effusion samples (n=5) and a 100% ctDNA detection rate in patients with extracranial lesions and disease progression (n=6). These results highlight its potential as a cost-effective, highly sensitive, and robust platform for dynamic, real-time companion diagnostics, as well as non-invasive monitoring of treatment response and tumor evolution.

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.