Abstract 729TiP
Background
Lorlatinib is a novel third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) that has demonstrated superior potency over second-generation TKIs. Despite its promising profile, there is a significant gap in knowledge concerning the efficacy and safety of lorlatinib as a first-line treatment in Chinese patients with ALK-positive non-small cell lung cancer (NSCLC). Recent studies suggest that continuing TKI therapy beyond progression in NSCLC patients with oligometastasis could effectively target tumor cells that remain dependent on the EGFR pathway, while also preventing the disease flare observed after discontinuing the targeted agent.
Trial design
This real-world study aims to prospectively investigate whether local treatments (surgery, ablation, radiotherapy, and others) can extend the time to treatment discontinuation (TTD) during first-line (1L) lorlatinib therapy in Chinese patients with unresectable ALK+ NSCLC. The patients who achieve PR or SD with oligometastasis (a maximum of 3 organs, and no more than 5 lesions in total) after receiving lorlatinib should continue lorlatinib and will receive imaging assess per 8-12 weeks. If target lesions indicate stable in 2 consecutive imaging, investigators will organize MDT and comprehensively evaluate patients’ will to decide and choose local therapy. After local therapy, patients should continue taking lorlatinib. While those who achieve CR or with multiple metastasis will not receive any local therapy. Approximately eight sites across China will enroll patients from the initiation of the study until October 2025. The effectiveness and safety data for 1L lorlatinib treatment will be collected from the first dose until the 60th month. The primary objective is to evaluate the TTD of lorlatinib combined with local therapy in this patient group under real-world conditions. This study is pioneering in its exploration of the therapeutic modification of local treatments during 1L lorlatinib therapy for NSCLC. The results are expected to substantiate the potential benefits of integrating lorlatinib with local therapies to improve patient outcomes and prolong survival.
Clinical trial identification
Legal entity responsible for the study
The authors.
Funding
Pfizer.
Disclosure
All authors have declared no conflicts of interest.