GIOTRIF rPMS in Korean Patients With NSCLC
A Regulatory Requirement Post-marketing Surveillance Study to Monitor the Safety and Efficacy of GIOTRIF® (Afatinib Dimaleate, 20mg, 30mg, 40mg, q.d) in Korean Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations or Patients With Locally Advanced or Metastatic NSCLC of Squamous Histology Progressing on or After Platinum-based Chemotherapy
1 other identifier
observational
1,272
1 country
1
Brief Summary
To monitor the safety profile and efficacy of GIOTRIF® (afatinib dimaleate, q.d) in Korean patients with locally advanced or metastatic non-small cell lung cancer (NSCLC)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2014
CompletedStudy Start
First participant enrolled
October 31, 2014
CompletedFirst Posted
Study publicly available on registry
November 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2019
CompletedResults Posted
Study results publicly available
February 24, 2021
CompletedFebruary 24, 2021
February 1, 2021
5.2 years
October 20, 2014
December 21, 2020
February 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Adverse Drug Reactions (ADRs)
Percentage of participants with Adverse Drug Reactions (ADRs).
From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
Secondary Outcomes (3)
Progression-Free Survival (PFS) Rate at 48 Weeks
From week 0 until week 48. Up to 48 weeks.
Percentage of Participants With Best Response
Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks.
Overall Survival (OS)
From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
Study Arms (1)
GIOTRIF
Interventions
Eligibility Criteria
NSCLC in Korea
You may qualify if:
- Patients who have been started on GIOTRIF® in accordance with the approved label in Korea
- Age = 19 years at enrolment
- Patients who have signed on the data release consent form
You may not qualify if:
- Known hypersensitivity to afatinib or any of its excipients
- Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- Patients for whom GIOTRIF® is contraindicated according to the local label
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Multiple Locations, South Korea
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Center
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2014
First Posted
November 7, 2014
Study Start
October 31, 2014
Primary Completion
December 31, 2019
Study Completion
December 31, 2019
Last Updated
February 24, 2021
Results First Posted
February 24, 2021
Record last verified: 2021-02