Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
Design
Arms and outcomes
Arms (1)
- label
- GIOTRIF
- interventionNames
- Drug: GIOTRIF 20mg
- Drug: GIOTRIF 40mg
- Drug: GIOTRIF 30mg
Primary outcomes (1)
- measure
- Percentage of Participants With Adverse Drug Reactions (ADRs)
- timeFrame
- From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.
- description
- Percentage of participants with Adverse Drug Reactions (ADRs).
Secondary outcomes (3)
- measure
- Progression-Free Survival (PFS) Rate at 48 Weeks
- timeFrame
- From week 0 until week 48. Up to 48 weeks.
- description
- Progression-Free Survival (PFS) rate, defined as the percentage of patients who were alive and without disease progression at the 48-week tumour assessment. Progression was assessed by the investigator according to local standard pattern of care for non-small cell lung cancer (NSCLC). If a patient is known to have progressed, but the date of progression is not attainable, the last date when the patient was assessed will be used as date of progression. PFS rate at 48 weeks was estimated using Kaplan-Meier estimates on the PFS curve.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 110 Years
Show eligibility criteria text
Inclusion criteria: 1. Patients who have been started on GIOTRIF® in accordance with the approved label in Korea 2. Age = 19 years at enrolment 3. Patients who have signed on the data release consent form Exclusion criteria: 1. Known hypersensitivity to afatinib or any of its excipients 2. Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption 3. Patients for whom GIOTRIF® is contraindicated according to the local label
References
Publications (0)
Data not yet available