Carcinoma, Non-Small-Cell LungNCT02440854
Evaluate the Impact of Afatinib on Quality of Life and Symptom Burden of Greek Subjects With Advanced NSCLC in Routine Patient Care Settings
An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 7 sites in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- afatinib
- How many people
- 80 participants
- Where
- 7 sitesGreece
- Study dates
- 16 Feb 2016to 17 Feb 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: NSCLC EGFR mutation
Who may be able to join
- 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;
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Greece7 sites
University General Hospital of Evros
Alexandroupoli, 68100
Chest Hospital of Athens "Sotiria"
Athens, 115 27
"Attikon" University General Hospital of Attica
Haidari, 12462
University General Hospital of Heraklion
Heraklion, 71110
Bioclinic Thessaloniki
Thessaloniki, 54622
Interbalkan Medical Center of Thessaloniki
Thessaloniki, 57001
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, 57010
About this study
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.
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.
Read the detailed description
Study Design:
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- afatinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
afatinibDrug
Patients were treated as per the routine medical practice in terms of visit frequency, types of assessments performed and with adherence to the local prescribing requirements for afatinib.
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-small cell lung cancer (NSCLC) treated with afatinib | Patients with advanced/metastatic non-small cell lung cancer (NSCLC) in Greece treated with afatinib. Patients were treated as per the routine medical practice in terms of visit frequency, types of assessments performed and with adherence to the local prescribing requirements for afatinib. Patients were observed in the context of the study until the end of study participation, defined as a maximum of 48 months after afatinib treatment initiation or until disease progression, death, withdrawal of consent, unacceptable toxicity, study completion or physician's decision whichever occurred earlier. Receives: Drug: afatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Who Experienced a Minimum Clinically Important Improvement in Symptoms Over 6 Months of Treatment
Number of patients who experience a minimum clinically important improvement in symptoms is reported. A patient was categorized as having an improvement if the mean score of any two consecutive post-baseline Average Symptom Burden Index (ASBI) score of Lung Cancer Symptom Scale (LCSS) assessments for that patient was at least 10 points below the patient's ASBI score of LCSS at enrolment, over 6 months of treatment.
The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Each item is scored on a 100-millimeter (mm) Visual Analogue Scale (VAS), with score reported from 0 to 100, with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions was not completed, the ASBI score was not calculated.
Measured: Baseline and 6 months following start of treatment.
Secondary outcomes (29)
Patient-rated Average Symptom Burden Index (ASBI) Score of Lung Cancer Symptom Scale (LCSS)
Patient-rated ASBI score of LCSS at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study) is reported.
The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Each item was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions had not been completed, the ASBI score was not calculated.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Total Lung Cancer Symptom Scale (LCSS) Score
Patient-rated total LCSS score -defined as the average of the aggregate score of all 9 items that comprise the LCSS- at enrolment and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study).
The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Each item was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions had not been completed, the ASBI score was not calculated.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Loss of Appetite
Patient-rated LCSS individual item scores: Loss of appetite at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study).
The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Loss of appetite was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Fatigue
Patient-rated LCSS individual item scores: Fatigue at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study).
The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Fatigue was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Cough
Patient-rated LCSS individual item scores: Cough at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study).
The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Cough was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Dyspnoea
Patient-rated LCSS individual item scores: Dyspnoea at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study).
The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Dyspnoea was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Haemoptysis
Patient-rated LCSS individual item scores: Haemoptysis at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study).
The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Haemoptysis was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Pain
Patient-rated LCSS individual item scores: Pain at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study).
The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Pain was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Overall Symptomatic Distress
Patient-rated LCSS individual item scores: Overall symptomatic distress at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study).
The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Overall symptomatic distress was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions had not been completed, the ASBI score was not calculated.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Interference With Normal Activity
Patient-rated LCSS individual item scores: Interference with normal activity at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study).
The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Interference with normal activity was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions had not been completed, the ASBI score was not calculated.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Global Quality of Life (QoL)
Patient-rated LCSS individual item scores: Global Quality of Life (QoL) at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study).
The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Global Quality of Life (QoL) was scored on a 100-mm Visual Analogue Scale (VAS), with scores reported from 0 to 100 with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions had not been completed, the ASBI score was not calculated.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Mobility
Percentage of patients with reported problems for the EQ-5D-3L utility index score dimension: Mobility.
The EQ-5D-3L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1="no problems"; 2="some problems"; 3= "extreme problems". Reported are the percentage of patients with problem, consisting of both level 2 ("some problems") and level 3 ("extreme problems") with the remaining subjects having reported level 1 ("no problems").
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
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
Percentage of patients with reported problems for the EQ-5D-3L utility index score dimension: Self-care.
The EQ-5D-3L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1="no problems"; 2="some problems"; 3= "extreme problems". Reported are the percentage of patients with problem, consisting of both level 2 ("some problems") and level 3 ("extreme problems") with the remaining subjects having reported level 1 ("no problems").
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Patients With Reported Problems for theEuropean Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Usual Activities
Percentage of patients with reported problems for the EQ-5D-3L utility index score dimension: Usual activities.
The EQ-5D-3L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1="no problems"; 2="some problems"; 3= "extreme problems". Reported are the percentage of patients with problem, consisting of both level 2 ("some problems") and level 3 ("extreme problems") with the remaining subjects having reported level 1 ("no problems").
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
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
Percentage of patients with reported problems for the EQ-5D-3L utility index score dimension: Pain/discomfort.
The EQ-5D-3L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1="no problems"; 2="some problems"; 3= "extreme problems". Reported are the percentage of patients with problem, consisting of both level 2 ("some problems") and level 3 ("extreme problems") with the remaining subjects having reported level 1 ("no problems").
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
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
Percentage of patients with reported problems for the EQ-5D-3L utility index score dimension: Anxiety/depression.
The EQ-5D-3L descriptive system consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: 1="no problems"; 2="some problems"; 3= "extreme problems". Reported are the percentage of patients with problem, consisting of both level 2 ("some problems") and level 3 ("extreme problems") with the remaining subjects having reported level 1 ("no problems").
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
EQ-VAS Score
EQ-VAS score at enrolment and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study).
The EQ-VAS is a visual analogue scale (VAS) that takes values between 100 (best imaginable health) and 0 (worst imaginable health), on which patients provide a global assessment of their health.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 0
Percentage of participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0 at baseline and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). ECOG has 6 grades (0-5, where 0 is the best possible score and 5 the worst):
0 = Fully active, able to carry on all pre-disease performance without restriction.
- = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
- = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.
- = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
- = Dead.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 1
Percentage of participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 1 at baseline and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). ECOG has 6 grades (0-5, where 0 is the best possible score and 5 the worst):
0 = Fully active, able to carry on all pre-disease performance without restriction.
- = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
- = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.
- = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
- = Dead.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 2
Percentage of participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 2 at baseline and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). ECOG has 6 grades (0-5, where 0 is the best possible score and 5 the worst):
0 = Fully active, able to carry on all pre-disease performance without restriction.
- = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
- = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.
- = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
- = Dead.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 3
Percentage of participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 3 at baseline and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). ECOG has 6 grades (0-5, where 0 is the best possible score and 5 the worst):
0 = Fully active, able to carry on all pre-disease performance without restriction.
- = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
- = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.
- = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
- = Dead.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 4
Percentage of participants with Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 4 at baseline and at the post-baseline predefined timepoints (i.e., every 2 months (± 3 weeks) during the first 12 months of therapy and every 6 months (±3 weeks) thereafter until the end of patient's participation in the study). ECOG has 6 grades (0-5, where 0 is the best possible score and 5 the worst):
0 = Fully active, able to carry on all pre-disease performance without restriction.
- = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work.
- = Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours.
- = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours.
- = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair.
- = Dead.
Measured: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Ratio of Afatinib Tablets Actually Taken to Doses Prescribed Over the Study Participation Period
Ratio of afatinib tablets actually taken to doses prescribed over the study participation period. Ratio = doses taken / doses prescribed.
Measured: Up to 42 months.
Number of Patients With a Reason for Missing Afatinib Tablets
Number of patients with a reason for missing afatinib tablets. One participant can have multiple missing doses for multiple reasons.
Measured: Up to 42 months.
Number of Patients With a Reason for Discontinuation of Afatinib
Number of patients with a reason for discontinuation of Afatinib throughout the study observation period.
Measured: Up to 42 months.
Number of Patients With a Reason for Treatment Interruptions
Number of patients with a reason for treatment interruptions throughout the study observation period. One participant can have multiple interruptions for multiple reasons.
Measured: Up to 42 months.
Number of Participants With Afatinib Interruptions or Dose Modifications
Number of participants with Afatinib interruptions or dose modifications (i.e., a dose increase or decrease).
Measured: Up to 42 months.
Number of Patients With a Reason for Dose Reduction
Number of patients with a reason for dose reduction throughout the study observation period.
Measured: Up to 42 months.
Number of Patients With a Reason for Dose Increase
Number of patients with a reason for dose increase throughout the study observation period.
Measured: Up to 42 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study start16 Feb 2016
- Primary completion17 Feb 2021
- Study completion17 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02440854
- Sponsor's protocol ID
- 1200.247
- Status last verified
- Feb 2022
- First submitted
- 28 Apr 2015
- Last updated
- 27 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02440854
- Acronym / sponsor ID
- 1200.247
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 16 Feb 2016 (actual)
- Primary completion
- 17 Feb 2021 (actual)
- Study completion
- 17 Feb 2021 (actual)
- First posted
- 12 May 2015 (estimated)
- Results
- Posted 27 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with non-small cell lung cancer (NSCLC) treated with afatinib | – | Drug: afatinibPatients with advanced/metastatic non-small cell lung cancer (NSCLC) in Greece treated with afatinib. Patients were treated as per the routine medical practice in terms of visit frequency, types of assessments performed and with adherence to the local prescribing requirements for afatinib. Patients were observed in the context of the study until the end of study participation, defined as a maximum of 48 months after afatinib treatment initiation or until disease progression, death, withdrawal of consent, unacceptable toxicity, study completion or physician's decision whichever occurred earlier. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- NSCLC EGFR mutation
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| afatinibPatients were treated as per the routine medical practice in terms of visit frequency, types of assessments performed and with adherence to the local prescribing requirements for afatinib. | Drug | Patients with non-small cell lung cancer (NSCLC) treated with afatinib |
Primary outcome
Number of Patients Who Experienced a Minimum Clinically Important Improvement in Symptoms Over 6 Months of Treatment
Time frame: Baseline and 6 months following start of treatment.
Number of patients who experience a minimum clinically important improvement in symptoms is reported. A patient was categorized as having an improvement if the mean score of any two consecutive post-baseline Average Symptom Burden Index (ASBI) score of Lung Cancer Symptom Scale (LCSS) assessments for that patient was at least 10 points below the patient's ASBI score of LCSS at enrolment, over 6 months of treatment. The patient-rated scale consists of six symptom-specific questions that address loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis. Each item is scored on a 100-millimeter (mm) Visual Analogue Scale (VAS), with score reported from 0 to 100, with 0 representing the best score. ASBI score was calculated by the mean of the 6 major lung cancer symptoms (loss of appetite, fatigue, cough, dyspnoea, pain and haemoptysis). For a given assessment, if any of the six symptom-specific questions was not completed, the ASBI score was not calculated.
29 secondary outcomes
Patient-rated Average Symptom Burden Index (ASBI) Score of Lung Cancer Symptom Scale (LCSS)
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Total Lung Cancer Symptom Scale (LCSS) Score
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Loss of Appetite
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Fatigue
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Cough
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Dyspnoea
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Haemoptysis
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Pain
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Overall Symptomatic Distress
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Interference With Normal Activity
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Global Quality of Life (QoL)
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Patients With Reported Problems for the European Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Mobility
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
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
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Patients With Reported Problems for theEuropean Quality of Life-5 Dimensions-3 Level (EQ-5D-3L) Utility Index Score Dimension: Usual Activities
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
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
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
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
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
EQ-VAS Score
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 0
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 1
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 2
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 3
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG PS) Score 4
Time frame: Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.
Ratio of Afatinib Tablets Actually Taken to Doses Prescribed Over the Study Participation Period
Time frame: Up to 42 months.
Number of Patients With a Reason for Missing Afatinib Tablets
Time frame: Up to 42 months.
Number of Patients With a Reason for Discontinuation of Afatinib
Time frame: Up to 42 months.
Number of Patients With a Reason for Treatment Interruptions
Time frame: Up to 42 months.
Number of Participants With Afatinib Interruptions or Dose Modifications
Time frame: Up to 42 months.
Number of Patients With a Reason for Dose Reduction
Time frame: Up to 42 months.
Number of Patients With a Reason for Dose Increase
Time frame: Up to 42 months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Boehringer Ingelheim at 7 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients Who Experienced a Minimum Clinically Important Improvement in Symptoms Over 6 Months of Treatment (time frame: Baseline and 6 months following start of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2022.