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NCT Number: NCT05599412

Post Marketing Surveillance(PMS) Study of Lorviqua in Korea

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

Recruiting

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Key information

Conditions

Metastatic ALK+ Non Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pfizer

Seoul, South Korea

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lorviqua

Drug

As provided in real world practice

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Oct 31, 2022
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.