NCT02440854 is a clinical trial of afatinib in Carcinoma, Non-Small-Cell Lung, sponsored by Boehringer Ingelheim.

Who is sponsoring NCT02440854?

NCT02440854 is sponsored by Boehringer Ingelheim.

What drugs are being tested in NCT02440854?

Interventions in NCT02440854: afatinib.

What condition does NCT02440854 study?

NCT02440854 studies Carcinoma, Non-Small-Cell Lung.

Is NCT02440854 still recruiting?

NCT02440854 is currently completed. Last updated 27 April 2022.

Are results published for NCT02440854?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-04-27 · How we verify

NCT02440854

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Results posted Last updated 27 April 2022

What this trial tests

trial testing afatinib in Carcinoma, Non-Small-Cell Lung in 80 participants. Completed in 17 February 2021.

Timeline

16 February 2016

Primary endpoint
17 February 2021

17 February 2021

Quick facts

Lead sponsor	Boehringer Ingelheim
Status	Completed
Study type	OBSERVATIONAL
Enrollment	80
Start date	16 February 2016
Primary completion	17 February 2021
Estimated completion	17 February 2021
Sites	7 locations across Greece

Drugs / interventions tested

afatinib (afatinib) — full drug profile →

Conditions studied

Carcinoma, Non-Small-Cell Lung — all drugs for Carcinoma, Non-Small-Cell Lung →

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

18 and older, any sex, with Carcinoma, Non-Small-Cell Lung. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients Who Experienced a Minimum Clinically Important Improvement in Symptoms Over 6 Months of Treatment Primary · 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-milli

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	13

Patient-rated Average Symptom Burden Index (ASBI) Score of Lung Cancer Symptom Scale (LCSS) Secondary · Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.

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 cance

Baseline

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	14.1	± 12.2

Month 2

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	11.5	± 10.3

Month 4

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	9.3	± 9.0

Month 6

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	7.1	± 8.3

Month 8

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	7.6	± 7.3

Month 10

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	7.8	± 8.7

Month 12

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	7.6	± 10.5

Month 18

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	5.3	± 6.4

Patient-rated Total Lung Cancer Symptom Scale (LCSS) Score Secondary · Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.

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 rep

Baseline

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	17.0	± 13.1

Month 2

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	14.7	± 11.3

Month 4

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	12.4	± 10.1

Month 6

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	10.7	± 9.2

Month 8

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	11.7	± 8.6

Month 10

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	11.1	± 9.3

Month 12

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	10.6	± 10.6

Month 18

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	8.3	± 7.8

Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Loss of Appetite Secondary · Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.

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.

Baseline

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	17.8	± 21.9

Month 2

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	21.7	± 26.2

Month 4

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	15.9	± 19.9

Month 6

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	14.7	± 23.9

Month 8

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	12.1	± 19.4

Month 10

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	13.6	± 22.6

Month 12

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	11.7	± 20.6

Month 18

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	8.9	± 14.8

Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Fatigue Secondary · Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.

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.

Baseline

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	27.4	± 26.1

Month 2

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	22.0	± 21.8

Month 4

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	20.3	± 18.3

Month 6

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	16.7	± 20.9

Month 8

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	17.5	± 19.9

Month 10

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	17.2	± 17.5

Month 12

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	14.5	± 17.1

Month 18

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	12.6	± 16.5

Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Cough Secondary · Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.

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.

Baseline

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	14.9	± 21.5

Month 2

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	6.7	± 10.9

Month 4

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	8.5	± 14.5

Month 6

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	4.2	± 8.1

Month 8

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	4.1	± 7.5

Month 10

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	4.1	± 8.1

Month 12

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	6.5	± 13.5

Month 18

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	2.4	± 6.1

Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Dyspnoea Secondary · Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.

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.

Baseline

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	10.8	± 17.4

Month 2

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	7.5	± 16.5

Month 4

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	5.5	± 11.6

Month 6

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	3.4	± 8.4

Month 8

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	3.3	± 7.9

Month 10

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	4.4	± 9.1

Month 12

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	5.2	± 13.7

Month 18

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	2.3	± 4.9

Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Haemoptysis Secondary · Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.

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.

Baseline

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	1.6	± 5.0

Month 2

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	1.3	± 6.9

Month 4

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	1.0	± 4.4

Month 6

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	0.9	± 2.5

Month 8

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	1.4	± 3.4

Month 10

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	1.2	± 2.8

Month 12

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	1.4	± 3.3

Month 18

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	1.4	± 6.4

Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Pain Secondary · Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.

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.

Baseline

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	12.0	± 19.4

Month 2

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	9.7	± 16.3

Month 4

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	4.5	± 8.6

Month 6

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	3.0	± 5.4

Month 8

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	7.2	± 14.2

Month 10

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	6.5	± 11.4

Month 12

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	6.1	± 10.9

Month 18

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	4.2	± 8.7

Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Overall Symptomatic Distress Secondary · Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.

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 ca

Baseline

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	16.2	± 17.7

Month 2

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	15.9	± 15.6

Month 4

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	17.3	± 0.0

Month 6

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	13.8	± 16.3

Month 8

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	14.8	± 16.7

Month 10

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	12.7	± 14.5

Month 12

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	12.1	± 13.4

Month 18

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	12.0	± 12.7

Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Interference With Normal Activity Secondary · Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.

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 sc

Baseline

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	22.8	± 26.3

Month 2

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	19.6	± 20.8

Month 4

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	16.7	± 17.4

Month 6

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	16.3	± 16.1

Month 8

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	18.1	± 17.9

Month 10

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	15.9	± 16.5

Month 12

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	16.1	± 15.4

Month 18

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	12.6	± 17.4

Patient-rated Lung Cancer Symptom Scale (LCSS) Individual Item Scores: Global Quality of Life (QoL) Secondary · Baseline (Day 0) and at month 2, 4, 6, 8, 10, 12, 18, 24, 30, 36 and 42 post baseline.

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 ca

Baseline

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	29.6	± 24.8

Month 2

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	27.8	± 23.0

Month 4

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	23.8	± 18.6

Month 6

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	23.5	± 21.8

Month 8

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	26.9	± 23.0

Month 10

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	24.5	± 20.6

Month 12

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	21.9	± 16.0

Month 18

Group	Value	95% CI
Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib	18.2	± 16.8

Adverse events — posted to ClinicalTrials.gov

Time frame: Each participant was treated with afatinib and observed in the context of the study until the end of study participation, up to 42 months.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients With Non-small Cell Lung Cancer (NSCLC) Treated With Afatinib

Serious: 49/77 (64%)

Deaths: 7/80

Serious adverse events (17 terms)

Reaction	System	Patients With Non-small Ce…
Malignant neoplasm progression	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	—
Diarrhoea	Gastrointestinal disorders	—
Death	General disorders	—
Acute kidney injury	Renal and urinary disorders	—
Anaemia	Blood and lymphatic system disorders	—
Abdominal pain	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Pyrexia	General disorders	—
Lung abscess	Infections and infestations	—
Pneumonia	Infections and infestations	—
Hyponatraemia	Metabolism and nutrition disorders	—
Dementia	Nervous system disorders	—
Epilepsy	Nervous system disorders	—
Loss of consciousness	Nervous system disorders	—
Renal failure	Renal and urinary disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (15 terms — click to expand)

Reaction	System	Patients With Non-small Ce…
Diarrhoea	Gastrointestinal disorders	—
Rash	Skin and subcutaneous tissue disorders	—
Paronychia	Infections and infestations	—
Conjunctivitis	Infections and infestations	—
Nail dystrophy	Skin and subcutaneous tissue disorders	—
Fatigue	General disorders	—
Mucosal inflammation	General disorders	—
Decreased appetite	Metabolism and nutrition disorders	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—
Dermatitis	Skin and subcutaneous tissue disorders	—
Dry skin	Skin and subcutaneous tissue disorders	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Xeroderma	Skin and subcutaneous tissue disorders	—

Most-reported serious reactions: Malignant neoplasm progression, Pulmonary embolism, Diarrhoea, Death, Acute kidney injury, Anaemia, Abdominal pain, Nausea.

Data from ClinicalTrials.gov NCT02440854 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02440854 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boehringer Ingelheim
Last refreshed: 27 April 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02440854.

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NCT02440854

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (17 terms)

Sponsor's own description

Publications & conference data

Related trials

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Verify against primary sources