Working... Menu

GIOTRIF rPMS in Korean Patients With NSCLC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02285361
Recruitment Status : Recruiting
First Posted : November 7, 2014
Last Update Posted : March 20, 2019
Information provided by (Responsible Party):
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)

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

Layout table for study information
Study Type : Observational
Estimated Enrollment : 3000 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
Estimated Primary Completion Date : January 28, 2020
Estimated Study Completion Date : January 28, 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment

Drug: GIOTRIF 40mg

Drug: GIOTRIF 30mg

Primary Outcome Measures :
  1. All reported adverse events in patients who take at least one dose of GIOTRIF® based on the current authorized label in Korea will be noted. [ Time Frame: up to 28 days ]

Secondary Outcome Measures :
  1. Data regarding tumour assessments that are performed according to local standard of care for NSCLC may contribute to: Progression-Free Survival [ Time Frame: up to 48weeks ]
  2. Disease accessment. (It is classified as Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD)) [ Time Frame: up to 48weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02285361

Layout table for location contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127

Layout table for location information
Korea, Republic of
Multiple Locations, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Layout table for additonal information
Responsible Party: Boehringer Ingelheim Identifier: NCT02285361     History of Changes
Other Study ID Numbers: 1200.235
First Posted: November 7, 2014    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases