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NCT05599412
Post Marketing Surveillance(PMS) Study of Lorviqua in Korea
Conditions: Metastatic ALK+ Non Small Cell Lung Cancer
Sex: All
Ages: 18 Years – N/A
Enrollment: 600
Sponsor: Pfizer
Location: Korea, Republic of
Summary
The objective of this study is to monitor the usage of Lorviqua in real practice within label, including the adverse events associated with Lorviqua
Eligibility Criteria
Inclusion Criteria:Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after:alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; orcrizotinib and at least one other ALK TKI.Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the studyExclusion Criteria:Patients to whom Lorviqua is contraindicated as per the local labeling.
A. Hypersensitivity to Lorviqua or to any of the excipients of this product B. Lorviqua is contraindicated in patients taking concomitant use of strong CYP3A inducers (e.g.
rifampicin, carbamazepine, enzalutamide, mitotane, phenytoin and St. John's wort) C.
This medicinal product contains lactose as an excipient.
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose galactose malabsorption should not take this medicinal product.Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
Source: ClinicalTrials.gov (NCT05599412). StuddyBuddy aggregates publicly available trial information.