A Patient-Centric, Open-Label, Multicenter, Phase II Study of Lorlatinib Monotherapy in the First-Line Treatment of Patients With locally Advanced or Metastatic ALK-Positive Non-Small Cell Lung Cancer (CTONG2203).
Jia-Xin Lin, Qing Zhou, Hong-Hong Yan, An-Wen Liu, Guo-Wu Wu, Qian Chu, Ying-Ying Du, Jiu-Wei Cui, Ying Cheng, Yi Yang, Hai-Peng Xu, Hai-Yan Tu, Yi-Long Wu, Si-Yang Maggie Liu
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引用次数: 0
Abstract
Background: Lorlatinib is a potent third-generation ALK tyrosine kinase inhibitor (TKI). CROWN study demonstrated remarkable efficacy and manageable toxicity of first-line lorlatinib treatment for advanced non-small cell lung cancer (NSCLC) with ALK rearrangements. However, only 10 ALK-positive NSCLC patients were randomized to the lorlatinib group in China mainland. There is a vast vacancy of efficacy and safety regarding first-line lorlatinib treatment in China advanced ALK-positive NSCLC. Additionally, understanding of the benefit-risk profile of lorlatinib in a broader population and real-world data of diversity of ALK-TKIs are limited.
Patients and methods: We adopted a patient-centric trial (PCT) design to provide more generalizable data to better inform clinical decision-making. This is a 3 cohorts, open-label, multicenter, phase II study (CTONG2203), conducted to prospectively enroll 189 treatment-naïve patients with advanced ALK-positive NSCLC in China, which was divided into 2 treatment intervention cohorts and real-world observing (RO) cohort. The treatment intervention cohorts include restrictive eligibility criteria "CROWN criteria (CC) cohort," and broadening eligibility criteria "Expand Eligibility Criteria (EC) cohort," who will receive first-line lorlatinib treatment. And we concomitantly set up a prospective RO cohort to observe the clinical outcomes of these patients treated with different ALK-TKI who received physician's therapy of choice.
Conclusion: This patient-centric study will contribute data on efficacy, safety and resistance mechanism of first-line lorlatinib, and offer better perspectives on the current status of real-world treatment of ALK-TKIs in advanced ALK-positive NSCLC in China.
期刊介绍：
Clinical Lung Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of lung cancer. Clinical Lung Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of lung cancer. The main emphasis is on recent scientific developments in all areas related to lung cancer. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.
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