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Evaluate the Impact of Afatinib on Quality of Life and Symptom Burden of Greek Subjects With Advanced NSCLC in Routine Patient Care Settings

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ClinicalTrials.gov Identifier: NCT02440854
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:

This non-interventional study will include a representative sample of patients with locally advanced or metastatic NSCLC harboring Epidermal Growth Factor Receptor (EGFR)-mutations in Greece. Eligible NSCLC patients, for whom the physician has decided to initiate treatment with the study medication (afatinib, GIOTRIF®) will be treated according to the local prescribing information and standard medical practice in terms of visit frequency and types of assessments performed.

The study will investigate the impact of GIOTRIF (Afatinib) on patients' disease-related symptom burden and Health-Related Quality of Life (HRQoL) in a real world clinical setting in Greece.The Average Symptom Burden Index (ASBI) score of the Lung Cancer Symptom Scale (LCSS) in eligible patients, after 6 months of therapy, will be analyzed.

The overall study duration period is expected to be 60 months, including a 48-month enrollment period and a minimum 12-month follow-up period.


Condition or disease
Carcinoma, Non-Small-Cell Lung

Detailed Description:
Study Design:

Study Type : Observational
Estimated Enrollment : 160 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Multicentre, Cohort Study to Assess the Impact on SYMptom Burden and Patient Health-related Quality of Life of Afatinib Treatment in Advanced Non-small Cell Lung Cancer in a Real World Setting in Greece.
Actual Study Start Date : February 16, 2016
Estimated Primary Completion Date : March 2, 2020
Estimated Study Completion Date : October 20, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Afatinib



Primary Outcome Measures :
  1. 6-month symptom improvement rate using the LCSS ASBI [ Time Frame: up to 42 months ]

Secondary Outcome Measures :
  1. Change from enrolment in the proportion of patients in each of the EQ-5D dimension levels (no problems, with problems) at post-baseline timepoints (every 2 months during the first 12 months of therapy and every 6 months thereafter up to 48 months) [ Time Frame: up to 48 months ]
  2. Change from enrolment in the EQ-VAS score at post-baseline timepoints (every 2 months during the first 12 months of therapy and every 6 months thereafter up to 48 months) [ Time Frame: up to 48 months ]
  3. Change from baseline in ECOG PS score at post-baseline timepoints (every 2 months during the first 12 months of therapy and every 6 months thereafter up to 48 months) [ Time Frame: up to 48 months ]
  4. Ratio of afatinib doses actually taken to doses prescribed over the study participation period (up to 48 months) [ Time Frame: up to 48 months ]
  5. Reasons for any discrepancies between the afatinib doses actually taken to doses prescribed over the study participation (up to 48 months) [ Time Frame: up to 48 months ]
  6. Change from enrolment in the LCSS total and domain scores at post-baseline timepoints (every 2 months during the first 12 months of therapy and every 6 months thereafter up to 48 months) [ Time Frame: up to 48 months ]
  7. Change from enrolment in the ASBI score at post-baseline timepoints (every 2 months during the first 12 months of therapy and every 6 months thereafter up to 48 months); [ Time Frame: up to 48 months ]
  8. Proportions of patients with afatinib treatment discontinuations, over the study participation (up to 48 months) [ Time Frame: up to 48 months ]
  9. Proportions of patients with afatinib temporary interruptions, over the study participation (up to 48 months) [ Time Frame: up to 48 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
NSCLC EGFR mutation
Criteria

Inclusion criteria:

  • Adult outpatients (18 years and older) of either gender;
  • Histologically or cytologically confirmed locally advanced or metastatic (IIIB/IV) NSCLC of any histological type with activating EGFR mutation(s) according to local laboratory EGFR testing;
  • EGFR- tyrosine kinase inhibitor (TKI) naive patients;
  • Patients for whom the decision to prescribe therapy with afatinib (GIOTRIF®) according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study; the assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of afatinib is clearly separated from the physicians decision to include the patient in the current study;
  • Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;

Exclusion criteria:

  • Patients who have initiated treatment with Afatinib more than 7 days prior to their enrolment into the study;
  • Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
  • Receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with afatinib

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): NCT02440854


Contacts
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
Greece
University of Thrace, Pulmonary clinic Recruiting
Alexandroupolis, Greece, 68100
Chest Hospital of Athens "Sotiria" Recruiting
Athens, Greece, 115 27
"Attikon" University General Hospital of Attica Recruiting
Haidari, Greece, 12462
University General Hospital of Heraklion Recruiting
Heraklion, Greece, 71110
Bioclinic Thessaloniki Recruiting
Thessaloniki, Greece, 54622
Interbalkan Medical Center of Thessaloniki Recruiting
Thessaloniki, Greece, 57001
General Hospital of Thessaloniki "G. Papanikolaou" Recruiting
Thessaloniki, Greece, 57010
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02440854     History of Changes
Other Study ID Numbers: 1200.247
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018

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