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Afatinib Treatment for Patients With EGFR Mutation Positive NSCLC Who Are Age 70 or Older

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02514174
Recruitment Status : Completed
First Posted : August 3, 2015
Results First Posted : March 30, 2020
Last Update Posted : March 30, 2020
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Carcinoma, Non-Small-Cell Lung
ErbB Receptors
Intervention Drug: Afatinib
Enrollment 25
Recruitment Details Open-label, non-randomized, Phase IV, single arm study
Pre-assignment Details All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Arm/Group Title Afatinib
Hide Arm/Group Description

Giotrif® / Gilotrif® (Afatinib) starting at 30 mg daily dose

All participants received the same treatment (afatinib) with starting dose of 30 milligram (mg) per day with one possible dose reduction to 20 mg per day.

Mode of administration: Orally one film-coated tablet, once daily

Period Title: Overall Study
Started [1] 25
Completed 0
Not Completed 25
Reason Not Completed
Patient refused to continue medication             1
Adverse Event             2
Study closed by sponsor             9
Progressive disease             11
Treatment change             1
Treated off study with Afatinib.             1
[1]
(Participants who were dispensed afatinib and were documented to have taken at least one dose.)
Arm/Group Title Afatinib
Hide Arm/Group Description

Giotrif® / Gilotrif® (Afatinib) starting at 30 mg daily dose

All participants received the same treatment (afatinib) with starting dose of 30 milligram (mg) per day with one possible dose reduction to 20 mg per day.

Mode of administration: Orally one film-coated tablet, once daily

Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
All participants who received at least one dose of afatinib were included in the treated set. The analyses of safety and efficacy were performed on the treated set.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
79.2  (5.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
14
  56.0%
Male
11
  44.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Hispanic or Latino
3
  12.0%
Not Hispanic or Latino
22
  88.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
American Indian or Alaska Native
1
   4.0%
Asian
8
  32.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   8.0%
White
14
  56.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
1.Primary Outcome
Title Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib
Hide Description On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).
Time Frame On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of afatinib were included in the treated set. The analyses of safety and efficacy were performed on the treated set.
Arm/Group Title Afatinib
Hide Arm/Group Description:

Giotrif® / Gilotrif® (Afatinib) starting at 30 mg daily dose

All participants received the same treatment (afatinib) with starting dose of 30 milligram (mg) per day with one possible dose reduction to 20 mg per day.

Mode of administration: Orally one film-coated tablet, once daily

Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage
32.0
(14.9 to 53.5)
2.Secondary Outcome
Title Percentage of Participants With Adverse Event = Diarrhoea of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Higher
Hide Description

Percentage of participants with adverse event being diarrhoea of CTCAE grade 3 or higher.

On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).

Time Frame On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of afatinib were included in the treated set. The analyses of safety and efficacy were performed on the treated set.
Arm/Group Title Afatinib
Hide Arm/Group Description:

Giotrif® / Gilotrif® (Afatinib) starting at 30 mg daily dose

All participants received the same treatment (afatinib) with starting dose of 30 milligram (mg) per day with one possible dose reduction to 20 mg per day.

Mode of administration: Orally one film-coated tablet, once daily

Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Percentage of participants
8.0
3.Secondary Outcome
Title Percentage of Participants With Adverse Event = Rash/Acne (Grouped Term) of CTCAE Grade 3 or Higher
Hide Description

Percentage of participants with adverse event = rash/acne (grouped term) of CTCAE grade 3 or higher.

MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated.

On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).

Time Frame On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of afatinib were included in the treated set. The analyses of safety and efficacy were performed on the treated set.
Arm/Group Title Afatinib
Hide Arm/Group Description:

Giotrif® / Gilotrif® (Afatinib) starting at 30 mg daily dose

All participants received the same treatment (afatinib) with starting dose of 30 milligram (mg) per day with one possible dose reduction to 20 mg per day.

Mode of administration: Orally one film-coated tablet, once daily

Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Percentage of participants
0.0
4.Secondary Outcome
Title Percentage of Participants With Adverse Event = Stomatitis (Grouped Term) of CTCAE Grade 3 or Higher
Hide Description

Percentage of participants with adverse event = stomatitis (grouped term) of CTCAE grade 3 or higher.

MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated.

On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).

Time Frame On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of afatinib were included in the treated set. The analyses of safety and efficacy were performed on the treated set.
Arm/Group Title Afatinib
Hide Arm/Group Description:

Giotrif® / Gilotrif® (Afatinib) starting at 30 mg daily dose

All participants received the same treatment (afatinib) with starting dose of 30 milligram (mg) per day with one possible dose reduction to 20 mg per day.

Mode of administration: Orally one film-coated tablet, once daily

Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Percentage of participants
4.0
5.Secondary Outcome
Title Percentage of Participants With Adverse Event = Paronychia (Grouped Term) of CTCAE Grade 3 or Higher
Hide Description

Percentage of participants with adverse event = paronychia (grouped term) of CTCAE grade 3 or higher.

MedDRA preferred terms that described AEs of similar nature were grouped together as "grouped term" to ensure that important events would not be underestimated.

On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent for study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).

Time Frame On-treatment period + 28 days (residual effect period), up to 1057 + 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least one dose of afatinib were included in the treated set. The analyses of safety and efficacy were performed on the treated set.
Arm/Group Title Afatinib
Hide Arm/Group Description:

Giotrif® / Gilotrif® (Afatinib) starting at 30 mg daily dose

All participants received the same treatment (afatinib) with starting dose of 30 milligram (mg) per day with one possible dose reduction to 20 mg per day.

Mode of administration: Orally one film-coated tablet, once daily

Overall Number of Participants Analyzed 25
Measure Type: Number
Unit of Measure: Percentage of participants
8.0
6.Secondary Outcome
Title Time to First Dose Reduction of Afatinib Caused by Adverse Events
Hide Description

Time to first dose reduction of afatinib caused by adverse events is defined as time from the date of the first administration of afatinib to the date of first dose reduction of afatinib caused by adverse events. Participants without AEs leading to dose reduction were censored at date of last intake of afatinib.

On-treatment period = First administration of afatinib until progression or intolerable adverse events or other reasons necessitating withdrawal (participant's withdrawal of consent from study treatment, participant diagnosed with interstitial lung disease, participant no longer able to receive study treatments, participant had a significant deviation from the protocol or eligibility criteria).

The cumulative probability of no dose reduction at the respective time point is given by the Kaplan-Meier estimate at the respective time point based on time to first dose reduction of afatinib caused by adverse events.

Time Frame On-treatment period, up to 1057 days
Hide Outcome Measure Data
Hide Analysis Population Description

All participants who received at least one dose of afatinib were included in the treated set. The analyses of safety and efficacy were performed on the treated set.

The 'Number Analyzed' is the 'Number at risk' at the respective time point, that is the number of participants being treated with afatinib 30 mg at the respective time point.

Arm/Group Title Afatinib
Hide Arm/Group Description:

Giotrif® / Gilotrif® (Afatinib) starting at 30 mg daily dose

All participants received the same treatment (afatinib) with starting dose of 30 milligram (mg) per day with one possible dose reduction to 20 mg per day.

Mode of administration: Orally one film-coated tablet, once daily

Overall Number of Participants Analyzed 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Probability
0 months (= First administration of afatinib) Number Analyzed 25 participants
1.0
(1.0 to 1.0)
3 months Number Analyzed 18 participants
0.7889
(0.5642 to 0.9064)
6 months Number Analyzed 18 participants
0.7450
(0.5176 to 0.8768)
9 months Number Analyzed 13 participants
0.6519
(0.4214 to 0.8091)
12 months Number Analyzed 12 participants
0.6519
(0.4214 to 0.8091)
15 months Number Analyzed 9 participants
0.6519
(0.4214 to 0.8091)
18 months Number Analyzed 6 participants
0.6519
(0.4214 to 0.8091)
21 months Number Analyzed 5 participants
0.6519
(0.4214 to 0.8091)
24 months Number Analyzed 5 participants
0.6519
(0.4214 to 0.8091)
27 months Number Analyzed 2 participants
0.6519
(0.4214 to 0.8091)
30 months Number Analyzed 1 participants
0.6519
(0.4214 to 0.8091)
33 months Number Analyzed 1 participants
0.6519
(0.4214 to 0.8091)
Time Frame On-treatment period+28 days, up to 1057+28 days. On-treatment period=First administration of afatinib until progression or intolerable AEs or other reasons necessitating withdrawal (participant withdrew consent or was diagnosed with interstitial lung disease or was no longer able to receive study treatments or had a significant deviation from the protocol or eligibility criteria). Time Frame for All-Cause Mortality is On-treatment period + Follow-Up, up to 1096 days.
Adverse Event Reporting Description

Adverse events (AEs) were reported for the treated set which comprises all participants who received at least one dose of afatinib.

From 28 days after last trial drug intake new AEs were only reported if they were considered related to trial drug.

 
Arm/Group Title Afatinib 30 mg
Hide Arm/Group Description

Giotrif® / Gilotrif® (Afatinib) starting at 30 mg daily dose

All participants received the same treatment (afatinib) with starting dose of 30 milligram (mg) per day with one possible dose reduction to 20 mg per day.

Mode of administration: Orally one film-coated tablet, once daily

All-Cause Mortality
Afatinib 30 mg
Affected / at Risk (%)
Total   7/25 (28.00%) 
Hide Serious Adverse Events
Afatinib 30 mg
Affected / at Risk (%)
Total   10/25 (40.00%) 
Gastrointestinal disorders   
Diarrhoea  1  1/25 (4.00%) 
Nausea  1  1/25 (4.00%) 
Rectal haemorrhage  1  1/25 (4.00%) 
Vomiting  1  2/25 (8.00%) 
Infections and infestations   
Pneumonia  1  1/25 (4.00%) 
Urinary tract infection  1  1/25 (4.00%) 
Injury, poisoning and procedural complications   
Fall  1  1/25 (4.00%) 
Fracture displacement  1  1/25 (4.00%) 
Humerus fracture  1  1/25 (4.00%) 
Joint dislocation  1  1/25 (4.00%) 
Metabolism and nutrition disorders   
Dehydration  1  2/25 (8.00%) 
Hyponatraemia  1  1/25 (4.00%) 
Hypovolaemia  1  1/25 (4.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Malignant pleural effusion  1  1/25 (4.00%) 
Nervous system disorders   
Seizure  1  1/25 (4.00%) 
Syncope  1  2/25 (8.00%) 
Renal and urinary disorders   
Acute kidney injury  1  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/25 (4.00%) 
Dyspnoea  1  1/25 (4.00%) 
Pneumothorax  1  1/25 (4.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Afatinib 30 mg
Affected / at Risk (%)
Total   25/25 (100.00%) 
Blood and lymphatic system disorders   
Anaemia  1  2/25 (8.00%) 
Eye disorders   
Dry eye  1  7/25 (28.00%) 
Vision blurred  1  2/25 (8.00%) 
Gastrointestinal disorders   
Abdominal pain  1  2/25 (8.00%) 
Abdominal pain upper  1  3/25 (12.00%) 
Constipation  1  6/25 (24.00%) 
Diarrhoea  1  22/25 (88.00%) 
Dry mouth  1  8/25 (32.00%) 
Dyspepsia  1  3/25 (12.00%) 
Haemorrhoids  1  2/25 (8.00%) 
Nausea  1  9/25 (36.00%) 
Oral pain  1  2/25 (8.00%) 
Proctalgia  1  2/25 (8.00%) 
Rectal haemorrhage  1  2/25 (8.00%) 
Stomatitis  1  9/25 (36.00%) 
Vomiting  1  6/25 (24.00%) 
General disorders   
Chills  1  2/25 (8.00%) 
Fatigue  1  12/25 (48.00%) 
Gait disturbance  1  2/25 (8.00%) 
Non-cardiac chest pain  1  3/25 (12.00%) 
Oedema  1  2/25 (8.00%) 
Oedema peripheral  1  3/25 (12.00%) 
Pain  1  4/25 (16.00%) 
Pyrexia  1  2/25 (8.00%) 
Infections and infestations   
Bronchitis  1  2/25 (8.00%) 
Conjunctivitis  1  2/25 (8.00%) 
Fungal skin infection  1  2/25 (8.00%) 
Nail infection  1  2/25 (8.00%) 
Paronychia  1  6/25 (24.00%) 
Pneumonia  1  3/25 (12.00%) 
Sinusitis  1  3/25 (12.00%) 
Upper respiratory tract infection  1  8/25 (32.00%) 
Urinary tract infection  1  4/25 (16.00%) 
Injury, poisoning and procedural complications   
Contusion  1  2/25 (8.00%) 
Skin abrasion  1  2/25 (8.00%) 
Investigations   
Weight decreased  1  3/25 (12.00%) 
Metabolism and nutrition disorders   
Decreased appetite  1  8/25 (32.00%) 
Dehydration  1  3/25 (12.00%) 
Hypokalaemia  1  4/25 (16.00%) 
Hypomagnesaemia  1  3/25 (12.00%) 
Hyponatraemia  1  3/25 (12.00%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  4/25 (16.00%) 
Back pain  1  7/25 (28.00%) 
Flank pain  1  2/25 (8.00%) 
Joint swelling  1  3/25 (12.00%) 
Muscle spasms  1  5/25 (20.00%) 
Musculoskeletal chest pain  1  2/25 (8.00%) 
Musculoskeletal pain  1  3/25 (12.00%) 
Pain in extremity  1  3/25 (12.00%) 
Nervous system disorders   
Dizziness  1  4/25 (16.00%) 
Headache  1  4/25 (16.00%) 
Hypoaesthesia  1  2/25 (8.00%) 
Neuropathy peripheral  1  3/25 (12.00%) 
Paraesthesia  1  2/25 (8.00%) 
Psychiatric disorders   
Anxiety  1  2/25 (8.00%) 
Insomnia  1  5/25 (20.00%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  7/25 (28.00%) 
Dyspnoea  1  6/25 (24.00%) 
Epistaxis  1  8/25 (32.00%) 
Nasal discomfort  1  2/25 (8.00%) 
Nasal dryness  1  5/25 (20.00%) 
Oropharyngeal pain  1  3/25 (12.00%) 
Productive cough  1  3/25 (12.00%) 
Rhinitis allergic  1  2/25 (8.00%) 
Rhinorrhoea  1  2/25 (8.00%) 
Upper-airway cough syndrome  1  2/25 (8.00%) 
Skin and subcutaneous tissue disorders   
Alopecia  1  5/25 (20.00%) 
Dermatitis acneiform  1  4/25 (16.00%) 
Dry skin  1  13/25 (52.00%) 
Erythema  1  2/25 (8.00%) 
Hair texture abnormal  1  2/25 (8.00%) 
Nail discolouration  1  2/25 (8.00%) 
Onychoclasis  1  7/25 (28.00%) 
Pruritus  1  4/25 (16.00%) 
Rash  1  16/25 (64.00%) 
Rash maculo-papular  1  5/25 (20.00%) 
Scab  1  2/25 (8.00%) 
Skin atrophy  1  2/25 (8.00%) 
Skin discolouration  1  2/25 (8.00%) 
Skin exfoliation  1  3/25 (12.00%) 
Skin fissures  1  3/25 (12.00%) 
1
Term from vocabulary, MedDRA 22.0
Indicates events were collected by systematic assessment
Limitation: Protocol was amended on 15-February-2018 to reduce total sample size from n=50 participants to n=25 participants due to slow enrollment.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The rights of the investigator and of the sponsor with regard to publication of the results of this trial were described in a separate agreement between the investigator or the trial site and the sponsor. As a general rule, no trial results were to be published prior to finalization of the clinical trial report.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Boehringer Ingelheim, Call Center
Organization: Boehringer Ingelheim
Phone: 1-800-243-0127
EMail: clintriage.rdg@boehringer-ingelheim.com
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02514174    
Other Study ID Numbers: 1200.209
First Submitted: July 17, 2015
First Posted: August 3, 2015
Results First Submitted: March 16, 2020
Results First Posted: March 30, 2020
Last Update Posted: March 30, 2020