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Post Marketing Surveillance(PMS) Study of Lorviqua in Korea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05599412
Recruitment Status : Not yet recruiting
First Posted : October 31, 2022
Last Update Posted : May 8, 2023
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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

Condition or disease Intervention/treatment
Metastatic ALK+ Non Small Cell Lung Cancer Drug: Lorviqua

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Lorviqua (Registered)
Estimated Study Start Date : June 1, 2023
Estimated Primary Completion Date : August 10, 2028
Estimated Study Completion Date : August 10, 2028

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Korean patients with Metastatic ALK+ Non small cell lung cancer Drug: Lorviqua
As provided in real world practice


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of the adverse events from baseline [ Time Frame: 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 Outcome Measures :
  1. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) [ Time Frame: Up to 2 years ]
    To assess the effectiveness of Lorviqua® in patients with ALK-positive metastatic NSCLC under routine clinical practice in Korea.

  2. Partial Response (PR) [ Time Frame: Up to 2 years ]
  3. Stable Disease (SD) [ Time Frame: Up to 2 years ]
  4. Progressive Disease (PD) [ Time Frame: Up to 2 years ]
  5. Complete Response (CR) [ Time Frame: Up to 2 Years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Korean patient who has a disease for which Lorlatinib is indicated
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05599412


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Korea, Republic of
Pfizer
Seoul, Korea, Republic of, 01037
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT05599412    
Other Study ID Numbers: B7461034
First Posted: October 31, 2022    Key Record Dates
Last Update Posted: May 8, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases