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

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)

Study Overview

• Status: Completed
• Conditions: Carcinoma, Non-Small-Cell Lung
• Intervention / Treatment: Drug: GIOTRIF 20mg; Drug: GIOTRIF 40mg; Drug: GIOTRIF 30mg

• Study Type: Observational
• Enrollment (Actual): 1272

Contacts and Locations

Study Locations

• Korea, Republic of
  • Multiple Locations, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

NSCLC in Korea

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GIOTRIF	Drug: GIOTRIF 20mg; NSCLC with GIOTRIF 20mg; Drug: GIOTRIF 40mg; NSCLC with GIOTRIF 40mg; Drug: GIOTRIF 30mg; NSCLC with GIOTRIF 30mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2014
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: October 20, 2014
• First Submitted That Met QC Criteria: November 6, 2014
• First Posted (Estimate): November 7, 2014

Study Record Updates

• Last Update Posted (Actual): February 24, 2021
• Last Update Submitted That Met QC Criteria: February 5, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: 1200.235