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Post Marketing Surveillance(PMS) Study of Lorviqua in Korea

Sponsor
Pfizer (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05599412
Collaborator
(none)
600
Enrollment
1
Location
64.3
Anticipated Duration (Months)
9.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase

Study Design

Study Type:
Observational
Anticipated 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)
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Aug 10, 2028
Anticipated Study Completion Date :
Aug 10, 2028

Arms and Interventions

Arm Intervention/Treatment
Korean patients with Metastatic ALK+ Non small cell lung cancer

Drug: Lorviqua
As provided in real world practice

Outcome Measures

Primary Outcome Measures

  1. 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 Outcome Measures

  1. 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.

  2. Partial Response (PR) [Up to 2 years]

  3. Stable Disease (SD) [Up to 2 years]

  4. Progressive Disease (PD) [Up to 2 years]

  5. Complete Response (CR) [Up to 2 Years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Lorviqua as monotherapy is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after:

  • alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy; or

  • crizotinib and at least one other ALK TKI.

  1. 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:

  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 CYP3A inducers (e.g. rifampicin, carbamazepine, enzalutamide, mitotane, phenytoin and St. John's wort) 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

Locations

Site City State Country Postal Code
1 Pfizer Seoul Korea, Republic of 01037

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT05599412
Other Study ID Numbers:
  • B7461034
First Posted:
Oct 31, 2022
Last Update Posted:
Jan 26, 2023
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Jan 26, 2023