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GIOTRIF rPMS in Korean Patients With NSCLC

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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:
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

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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

Resource links provided by the National Library of Medicine


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




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.




Information from the National Library of Medicine

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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

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 ClinicalTrials.gov identifier (NCT number): NCT02285361


Locations
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Korea, Republic of
Multiple Locations, Korea, Republic of
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Additional Information:
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02285361    
Other Study ID Numbers: 1200.235
First Posted: November 7, 2014    Key Record Dates
Results First Posted: February 24, 2021
Last Update Posted: February 24, 2021
Last Verified: February 2021
Additional relevant MeSH terms:
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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