GIOTRIF rPMS in Korean Patients With NSCLC

• ClinicalTrials.gov Identifier: NCT02285361
• Recruitment Status: Completed
• First Posted: November 7, 2014
• Results First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Sponsor: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Study Description

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)

Condition or disease	Intervention/treatment
Carcinoma, Non-Small-Cell Lung	Drug: GIOTRIF 20mg; Drug: GIOTRIF 40mg; Drug: GIOTRIF 30mg

Study Design

• Study Type: Observational
• Actual Enrollment: 1272 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: October 31, 2014
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants With Adverse Drug Reactions (ADRs) [ Time Frame: 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 :

1. Progression-Free Survival (PFS) Rate at 48 Weeks [ Time Frame: 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.

2. Percentage of Participants With Best Response [ Time Frame: 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.)
3. Overall Survival (OS) [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 110 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

NSCLC in Korea

Criteria

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

Contacts and Locations

Locations

Korea, Republic of

Multiple Locations, Korea, Republic of

Sponsors and Collaborators

Boehringer Ingelheim

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:

Study Protocol and Statistical Analysis Plan  [PDF] May 18, 2020

More Information

Additional Information:

Related Info 

• Responsible Party: Boehringer Ingelheim
• ClinicalTrials.gov Identifier: NCT02285361
• Other Study ID Numbers: 1200.235
• First Posted: November 7, 2014
• Results First Posted: February 24, 2021
• Last Update Posted: February 24, 2021
• Last Verified: February 2021

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases