Metastatic ALK+ Non Small Cell Lung CancerNCT05599412
Post Marketing Surveillance(PMS) Study of Lorviqua in Korea
An observational study of Metastatic ALK+ Non Small Cell Lung Cancer, run by Pfizer at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic ALK+ Non Small Cell Lung Cancer
- What is being tested?
- Lorviqua
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 May 2023to 31 Jan 2028
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Korean patient who has a disease for which Lorlatinib is indicated
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Single-arm, Open-label, Non-interventional, Multi-centre, Post Marketing Surveillance (PMS) Study of Lorviqua (Registered)
The objective of this study is to monitor the usage of Lorviqua in real practice within label, including the adverse events associated with Lorviqua
- Being tested
- Lorviqua
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LorviquaDrug
As provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| Korean patients with Metastatic ALK+ Non small cell lung cancer | Not described Receives: Drug: Lorviqua |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Secondary outcomes (5)
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.
Measured: Up to 2 years
Partial Response (PR)
Measured: Up to 2 years
Stable Disease (SD)
Measured: Up to 2 years
Progressive Disease (PD)
Measured: Up to 2 years
Complete Response (CR)
Measured: Up to 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2022
- Study start22 May 2023
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic ALK+ Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05599412
- Sponsor's protocol ID
- B7461034
- Other IDs
- NCT05599412
- Status last verified
- Mar 2026
- First submitted
- 26 Oct 2022
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.