GIOTRIF rPMS in Korean Patients With NSCLC

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: GIOTRIF 20mg; Drug: GIOTRIF 40mg; Drug: GIOTRIF 30mg

• Registration Number: NCT02285361
• Lead Sponsor: Boehringer Ingelheim

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-10-20
• Study Start: 2014-10-31
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-07
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Results First Submitted: 2020-12-21
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-05
• Last Update Submitted: 2021-02-05
• Results First Posted: 2021-02-24
• Last Update Posted: 2021-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1272

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GIOTRIF	GIOTRIF 40mg	-
GIOTRIF	GIOTRIF 30mg	-
GIOTRIF	GIOTRIF 20mg	-

Primary Outcome Measures

Name	Time	Method
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.	Percentage of participants with Adverse Drug Reactions (ADRs).

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS) Rate at 48 Weeks	From week 0 until week 48. Up to 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.
Percentage of Participants With Best Response	Tumour assessments performed at week 0, 8±2, 24±2 and 48±2. Up to 50 weeks.	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: 1. Complete response (CR); 2. Partial response (PR); 3. Stable disease (SD); 4. Progressive disease (PD); 5. Not evaluable for response, reasons to be specified (e.g. early death, tumour assessments incomplete, etc.)
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.	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.