Trial Outcomes & Findings for Afatinib in Patients With Non Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations (NCT NCT02044380)
NCT ID: NCT02044380
Last Updated: 2017-03-31
Results Overview
Safety was assessed by: 1. All serious adverse events (SAEs) 2. All adverse events (AEs) leading to treatment discontinuation or dose reduction of afatinib 3. Non-serious AEs assessed by the treating physician as related to afatinib.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
14 participants
Primary outcome timeframe
From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
Results posted on
2017-03-31
Participant Flow
This open-label, multicenter, single-arm trial evaluated the safety \& tolerability of the investigational drug afatinib.All entered patients in this trial (i.e., patients that had been treated with the trial medication) received continuous treatment of afatinib in the absence of disease progression or meeting any other trial withdrawal criteria.
The planned trial end date was 10 February 2016. On the end date, all patients on treatment that met the approved label indication were planned to be switched to commercially available afatinib.
Participant milestones
| Measure |
Afatinib 40 mg
Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Afatinib in Patients With Non Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Mutations
Baseline characteristics by cohort
| Measure |
Afatinib 40 mg
n=14 Participants
Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
|
|---|---|
|
Age, Continuous
|
66.0 Years
STANDARD_DEVIATION 10.8 • n=99 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: From first administration of treatment until 28 days after last drug administration, up to 80 weeks.Population: Treated set
Safety was assessed by: 1. All serious adverse events (SAEs) 2. All adverse events (AEs) leading to treatment discontinuation or dose reduction of afatinib 3. Non-serious AEs assessed by the treating physician as related to afatinib.
Outcome measures
| Measure |
Afatinib 40 mg
n=14 Participants
Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
|
|---|---|
|
Safety Assesment
Investigator defined drug-related AEs
|
92.9 Percentage of participants
|
|
Safety Assesment
AEs leading to dose reduction
|
35.7 Percentage of participants
|
|
Safety Assesment
AEs leading to discont. of trial drug
|
35.7 Percentage of participants
|
|
Safety Assesment
Serious AEs
|
21.4 Percentage of participants
|
Adverse Events
Afatinib 40 mg
Serious events: 3 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Afatinib 40 mg
n=14 participants at risk
Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Infections and infestations
Pneumonia
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Injury, poisoning and procedural complications
Radiation associated pain
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
Other adverse events
| Measure |
Afatinib 40 mg
n=14 participants at risk
Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
|
|---|---|
|
Cardiac disorders
Tachycardia
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Eye disorders
Growth of eyelashes
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Eye disorders
Lacrimation increased
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Eye disorders
Retinal tear
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Eye disorders
Vitreous floaters
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
92.9%
13/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Faeces soft
|
14.3%
2/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Flatulence
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Gastritis
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Glossitis
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Haematochezia
|
14.3%
2/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Haemorrhoids
|
14.3%
2/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Hiatus hernia
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Melaena
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
6/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Oesophagitis
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Rectal prolapse
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Stomatitis
|
21.4%
3/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Toothache
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
4/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Infections and infestations
Body tinea
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Infections and infestations
Conjunctivitis
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Infections and infestations
Fungal skin infection
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Infections and infestations
Lower respiratory tract infection
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Infections and infestations
Omphalitis
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Infections and infestations
Paronychia
|
28.6%
4/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Infections and infestations
Pneumonia
|
14.3%
2/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Infections and infestations
Sinusitis
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
21.4%
3/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Infections and infestations
Urinary tract infection
|
14.3%
2/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Investigations
Blood calcium decreased
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Investigations
Blood creatinine increased
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
42.9%
6/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
21.4%
3/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
2/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
14.3%
2/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Nervous system disorders
Amnesia
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Nervous system disorders
Dizziness
|
14.3%
2/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Nervous system disorders
Dysgeusia
|
35.7%
5/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Nervous system disorders
Head discomfort
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Nervous system disorders
Headache
|
28.6%
4/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Nervous system disorders
Muscle spasticity
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Nervous system disorders
Restless legs syndrome
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Psychiatric disorders
Insomnia
|
14.3%
2/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Psychiatric disorders
Mood altered
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Psychiatric disorders
Nightmare
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Renal and urinary disorders
Urinary hesitation
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Reproductive system and breast disorders
Breast pain
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
28.6%
4/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
21.4%
3/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
21.4%
3/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
14.3%
2/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
2/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
35.7%
5/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
21.4%
3/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Skin and subcutaneous tissue disorders
Exfoliative rash
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
14.3%
2/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
42.9%
6/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Skin and subcutaneous tissue disorders
Scab
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Vascular disorders
Hot flush
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Vascular disorders
Hypertension
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
Vascular disorders
Hypotension
|
14.3%
2/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
General disorders
Asthenia
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
General disorders
Fatigue
|
28.6%
4/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
General disorders
Mucosal inflammation
|
28.6%
4/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
General disorders
Oedema peripheral
|
28.6%
4/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
|
General disorders
Pyrexia
|
7.1%
1/14 • From first administration of treatment until 28 days after last drug administration, up to 80 weeks.
|
Additional Information
Boehringer Ingelheim Call Center
Boehringer Ingelheim
Phone: 1-800-243-0127
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER