ArticleBMJ open2025
Aumolertinib in combination with Lastet in the first-line treatment of EGFR-mutated, locally advanced or metastatic non-small cell lung cancer (EVOLUTION): protocol for a single-arm, phase II clinical trial.
Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06463171 (Phase II Clinical Study of Almonertinib in Combination With Lastet in the First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With EGFR Mutations), which is not on this map. Not yet cited in PubMed.
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Phase II Clinical Study of Almonertinib in Combination With Lastet in the First-line Treatment of Locally Advanced or Metastatic Non-small Cell Lung Cancer With EGFR Mutations
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7 authors.
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Abstract
introductionTargeted therapy is now the standard treatment for patients with epidermal growth factor receptor (EGFR) mutations, yet resistance continues to be a significant challenge. Enhancing the efficacy of targeted therapies and prolonging patient survival remain critical clinical priorities. Although combining third-generation EGFR tyrosine kinase inhibitors (TKIs) with intravenous chemotherapy has demonstrated promising results, it is unclear if oral chemotherapy regimens combined with EGFR TKIs could also improve survival outcomes. METHODS AND ANALYSIS: EVOLUTION is a multicentre, phase II clinical trial conducted across three tertiary hospitals in China: Shanghai Pulmonary Hospital (lead centre), Zhongshan Hospital Affiliated to Fudan University and Shanghai Fifth People's Hospital Affiliated to Fudan University. The study will enrol 60 patients with locally advanced or metastatic lung cancer harbouring EGFR-sensitive mutations who have not previously undergone systemic therapy. Participants will be administered a combination regimen of aumolertinib (110 mg orally, once a day in a 28-day cycle, continuously) and Lastet (25 mg orally, administered in a 28-day cycle, with 2 weeks on followed by 2 weeks off). The primary endpoint is progression-free survival, and the secondary endpoints are overall survival, objective response rate, disease control rate and duration of response. Tumour response will be assessed by the investigators according to the Response Evaluation Criteria in Solid Tumors 1.1. Patient enrolment is currently underway. ETHICS AND DISSEMINATION: Ethical approval for this study was granted by the Ethics Committee of Shanghai Pulmonary Hospital in April 2024 (approval number: L23-334). Patients will participate after providing informed consent. The results of the study will be disseminated through peer-reviewed journals and presentations at academic conferences. TRIAL REGISTRATION NUMBER: NCT06463171.
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