Clinical trial NCT02440854: Evaluate the Impact of Afatinib on Quality of Life and Symptom Burden of Greek Subjects With Advanced NSCLC in Routine Patient Care Settings
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-05-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NSCLC EGFR mutation

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.

Detailed description: Study Design:

Eligibility 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

Primary outcomes:
measure: Number of Patients Who Experienced a Minimum Clinically Important Improvement in Symptoms Over 6 Months of Treatment
timeFrame: Baseline and 6 months following start of treatment.
Secondary outcomes:
measure: Patient-rated Average Symptom Burden Index (ASBI) Score of Lung Cancer Symptom Scale (LCSS)
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Patient-rated Total Lung Cancer Symptom Scale (LCSS) Score
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Loss of Appetite
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Fatigue
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Cough
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Dyspnoea
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Haemoptysis
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Pain
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Overall Symptomatic Distress
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Interference With Normal Activity
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Global Quality of Life (QoL)
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Mobility
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Self-care
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Percentage of Patients With Reported Problems for theEuropean Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Usual Activities
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Pain/Discomfort
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Anxiety/Depression
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: EQ-VAS Score
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 0
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 1
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 2
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 3
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 4
timeFrame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
measure: Ratio of Afatinib Tablets Actually Taken to Doses Prescribed Over the Study Participation Period
timeFrame: Up to 42 months.
measure: Number of Patients With a Reason for Missing Afatinib Tablets
timeFrame: Up to 42 months.
measure: Number of Patients With a Reason for Discontinuation of Afatinib
timeFrame: Up to 42 months.
measure: Number of Patients With a Reason for Treatment Interruptions
timeFrame: Up to 42 months.
measure: Number of Participants With Afatinib Interruptions or Dose Modifications
timeFrame: Up to 42 months.
measure: Number of Patients With a Reason for Dose Reduction
timeFrame: Up to 42 months.
measure: Number of Patients With a Reason for Dose Increase
timeFrame: Up to 42 months.
Other outcomes:
Locations:
city: Alexandroupoli
country: Greece
facility: University General Hospital of Evros
city: Athens
country: Greece
facility: Chest Hospital of Athens "Sotiria"
city: Haidari
country: Greece
facility: "Attikon" University General Hospital of Attica
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
city: Thessaloniki
country: Greece
facility: Bioclinic Thessaloniki
city: Thessaloniki
country: Greece
facility: Interbalkan Medical Center of Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G. Papanikolaou"
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: