Post Marketing Surveillance(PMS) Study of Lorviqua in Korea

Study Overview
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Brief Summary
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The objective of this study is to monitor the usage of Lorviqua in real practice within label, including the adverse events associated with Lorviqua

Official Title
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A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Lorviqua (Registered)

Conditions
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Metastatic ALK+ Non Small Cell Lung Cancer

Intervention / Treatment
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* Drug: Lorviqua


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: Use in the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) 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 study. Exclusion Criteria: Patients meeting any of the following criteria will not be included in the study: 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 CYP3A4/5 inducers 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Korean patients with Metastatic ALK+ Non small cell lung cancer<br> | Drug: Lorviqua<br>* As provided in real world practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of the adverse events from baseline | This is a prospective, observational, non-interventional, multi-center study in which subjects will be administered as part of routine practice at Korean health care centers by accredited physicians. | Up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | To assess the effectiveness of Lorviqua® in patients with ALK-positive metastatic NSCLC under routine clinical practice in Korea. | Up to 2 years | 
| Partial Response (PR) |  | Up to 2 years | 
| Stable Disease (SD) |  | Up to 2 years | 
| Progressive Disease (PD) |  | Up to 2 years | 
| Complete Response (CR) |  | Up to 2 Years |