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Clinical TrialsClinical TrialsLORVIQUA® Clinical TrialsPhase I/II StudyCROWN StudySafetySafetyLORVIQUA® Safety ProfileDosingDosingLORVIQUA® DosingResourcesResourcesLORVIQUA® ResourcesCase StudiesVideosMaterials

The content of this webpage has been produced in line with the LORVIQUA®▼ (lorlatinib) Summary of Product Characteristics for Great Britain.
If you are an HCP in Northern Ireland click here.
LORVIQUA®▼ (lorlatinib) Prescribing Information for Great Britain and Northern Ireland click here. XALKORI® (crizotinib) Prescribing Information for Great Britain and Northern Ireland click here. Adverse event reporting information can be found at the bottom of the page.

Phase I/II Study

The safety and efficacy of LORVIQUA® was evaluated in a single-arm, multicentre, Phase I/II study of patients with ALK+ advanced NSCLC who were treatment naive in the advanced setting or had disease progression after at least one previous treatment with a TKI.1-4

Study Design

Study design and patient populations.

Learn moreLoadingEfficacy Outcomes

Outcomes for the primary endpoints of overall and intracranial objective tumour response and key secondary endpoints.

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Patient-reported outcomes assessed using the EORTC Quality of Life Questionnaire Core 30 (QLQ-C30) and corresponding Lung Cancer Module (QLQ-LC13).

See moreLoadingSafety Outcomes

Safety profile of LORVIQUA® in the Phase I/II Study.

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ALK: Anaplastic Lymphoma Kinase, EORTC: European Organisation for Research and Treatment of Cancer, OS: Overall Survival, PFS: Progression Free Survival, NSCLC: Non-Small Cell Lung Cancer, ORR: Objective Response Rate, TKI: Tyrosine Kinase Inhibitor

References

LORVIQUA® Summary of Product Characteristics for Great Britain click here. 
Solomon BJ, et al. Lancet Oncol. 2018;19(12):1654-1667.Shaw AT, et al. Lancet Oncol. 2017;18:1590-1599.Felip E, et al. Annals of Oncology. 2021;32(50):620-630.

LORVIQUA®▼(lorlatinib) Prescribing Information for Great Britain and Northern Ireland click here.
XALKORI® (crizotinib) Prescribing Information for Great Britain and Northern Ireland click here.
PP-LOR-GBR-0201. September 2022
LORVIQUA® Patient Case Studies

Use interactive hypothetical Patient case studies to understand the Patient pathway, from diagnosis to treatment, including monitoring Adverse Events

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