Metastatic ALK+ Non Small Cell Lung Cancer
Conditions
Brief 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
Interventions
DRUGLorviqua
As provided in real world practice
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. Use in the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) 2. 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: 1. 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. 2. Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of the adverse events from baseline | Up to 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) | Up to 2 years | To assess the effectiveness of Lorviqua® in patients with ALK-positive metastatic NSCLC under routine clinical practice in Korea. |
| 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 | — |
Countries
South Korea
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed