GIOTRIF rPMS in Korean Patients With NSCLC

Carcinoma, Non-Small-Cell Lung Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285361
• Other study ID #: 1200.235
• Status: Completed
• Start date: October 31, 2014
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1272
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• GIOTRIF 20mg
NSCLC with GIOTRIF 20mg
• GIOTRIF 40mg
NSCLC with GIOTRIF 40mg
• GIOTRIF 30mg
NSCLC with GIOTRIF 30mg

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Progression-Free Survival (PFS) Rate at 48 Weeks	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.	From week 0 until week 48. Up to 48 weeks.
Secondary	Percentage of Participants With Best Response	Best response is defined as the best response observed in individual subject from the date of the first administration of the study medication until the earliest recording of Progressive disease (PD), death, or end of treatment (as long as no additional anti-cancer therapy was implemented). Disease Assessment will be based on the assessment of cancer related symptoms and, if available, radiologic assessments as per standard of care at the site.; Tumour response according to investigator's assessment; Each patient will be assigned to one of the following categories: Complete response (CR); Partial response (PR); Stable disease (SD); Progressive disease (PD); Not evaluable for response, reasons to be specified (e.g. early death, tumour assessments incomplete, etc.)	Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks.
Secondary	Overall Survival (OS)	Overall Survival (OS), defined as time from the date of the first administration of afatinib to the date of death. Kaplan-Meier estimates and 95% confidence intervals for the 25th, median, and 75th percentiles of the survival distribution will be calculated for OS.; For patients with known date of death: OS [days] = date of death - (date of start of treatment) + 1; For patients known not death case: OS (censored) [days] = date of last contact showing no death - (date of start of treatment) + 1.	From baseline (Visit 1) until last visit (the last follow-up visit a patient actually attended during the study), up to 1051 days.

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