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A Patient-Centric, Open-Label, Multicenter, Phase II Study of Lorlatinib Monotherapy in the First-Line Treatment of
Jia-Xin Lin1, Qing Zhou1, Hong-Hong Yan1
1Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
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.
Clinical Trial Registration:
NCT06092086 (CTONG 2203).
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