NCT02514174

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

Completed Phase 4 Results posted Last updated 30 March 2020

What this trial tests

Phase 4 trial testing Afatinib in Carcinoma, Non-Small-Cell Lung in 25 participants. Completed in 25 April 2019.

Timeline

18 August 2015

Primary endpoint
28 March 2019

25 April 2019

Quick facts

Lead sponsor	Boehringer Ingelheim
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	18 August 2015
Primary completion	28 March 2019
Estimated completion	25 April 2019
Sites	10 locations across United States

Drugs / interventions tested

• Afatinib (afatinib) — full drug profile →

Conditions studied

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

Sponsor

Boehringer Ingelheim — full company profile →

Who can join

70 and older, any sex, with Carcinoma, Non-Small-Cell Lung or ErbB Receptors. 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.

Percentage of Participants Reporting an Adverse Event (AE) Leading to Dose Reduction of Afatinib Primary · On-treatment period + 28 days (residual effect period), up to 1057 + 28 days

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).

Group	Value	95% CI
Afatinib	32.0	14.9 – 53.5

Percentage of Participants With Adverse Event = Diarrhoea of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or Higher Secondary · On-treatment period + 28 days (residual effect period), up to 1057 + 28 days

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).

Group	Value	95% CI
Afatinib	8.0

Percentage of Participants With Adverse Event = Rash/Acne (Grouped Term) of CTCAE Grade 3 or Higher Secondary · On-treatment period + 28 days (residual effect period), up to 1057 + 28 days

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 signi

Group	Value	95% CI
Afatinib	0.0

Percentage of Participants With Adverse Event = Stomatitis (Grouped Term) of CTCAE Grade 3 or Higher Secondary · On-treatment period + 28 days (residual effect period), up to 1057 + 28 days

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 sign

Group	Value	95% CI
Afatinib	4.0

Percentage of Participants With Adverse Event = Paronychia (Grouped Term) of CTCAE Grade 3 or Higher Secondary · On-treatment period + 28 days (residual effect period), up to 1057 + 28 days

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 sign

Group	Value	95% CI
Afatinib	8.0

Time to First Dose Reduction of Afatinib Caused by Adverse Events Secondary · On-treatment period, up to 1057 days

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

0 months (= First administration of afatinib)

Group	Value	95% CI
Afatinib	1.0	1.0 – 1.0

3 months

Group	Value	95% CI
Afatinib	0.7889	0.5642 – 0.9064

6 months

Group	Value	95% CI
Afatinib	0.7450	0.5176 – 0.8768

9 months

Group	Value	95% CI
Afatinib	0.6519	0.4214 – 0.8091

12 months

Group	Value	95% CI
Afatinib	0.6519	0.4214 – 0.8091

15 months

Group	Value	95% CI
Afatinib	0.6519	0.4214 – 0.8091

18 months

Group	Value	95% CI
Afatinib	0.6519	0.4214 – 0.8091

21 months

Group	Value	95% CI
Afatinib	0.6519	0.4214 – 0.8091

Adverse events — posted to ClinicalTrials.gov

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.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Afatinib 30 mg

Serious: 10/25 (40%)

Deaths: 7/25

Serious adverse events (20 terms)

Reaction	System	Afatinib 30 mg
Vomiting	Gastrointestinal disorders	—
Dehydration	Metabolism and nutrition disorders	—
Syncope	Nervous system disorders	—
Diarrhoea	Gastrointestinal disorders	—
Nausea	Gastrointestinal disorders	—
Rectal haemorrhage	Gastrointestinal disorders	—
Pneumonia	Infections and infestations	—
Urinary tract infection	Infections and infestations	—
Fall	Injury, poisoning and procedural complications	—
Fracture displacement	Injury, poisoning and procedural complications	—
Humerus fracture	Injury, poisoning and procedural complications	—
Joint dislocation	Injury, poisoning and procedural complications	—
Hyponatraemia	Metabolism and nutrition disorders	—
Hypovolaemia	Metabolism and nutrition disorders	—
Malignant pleural effusion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Seizure	Nervous system disorders	—
Acute kidney injury	Renal and urinary disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—
Pneumothorax	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (81 terms — click to expand)

Reaction	System	Afatinib 30 mg
Diarrhoea	Gastrointestinal disorders	—
Rash	Skin and subcutaneous tissue disorders	—
Dry skin	Skin and subcutaneous tissue disorders	—
Fatigue	General disorders	—
Nausea	Gastrointestinal disorders	—
Stomatitis	Gastrointestinal disorders	—
Dry mouth	Gastrointestinal disorders	—
Upper respiratory tract infection	Infections and infestations	—
Decreased appetite	Metabolism and nutrition disorders	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—
Dry eye	Eye disorders	—
Back pain	Musculoskeletal and connective tissue disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Onychoclasis	Skin and subcutaneous tissue disorders	—
Constipation	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Paronychia	Infections and infestations	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—
Insomnia	Psychiatric disorders	—
Nasal dryness	Respiratory, thoracic and mediastinal disorders	—
Alopecia	Skin and subcutaneous tissue disorders	—
Rash maculo-papular	Skin and subcutaneous tissue disorders	—
Pain	General disorders	—
Urinary tract infection	Infections and infestations	—
Hypokalaemia	Metabolism and nutrition disorders	—
Arthralgia	Musculoskeletal and connective tissue disorders	—
Dizziness	Nervous system disorders	—
Headache	Nervous system disorders	—
Dermatitis acneiform	Skin and subcutaneous tissue disorders	—
Pruritus	Skin and subcutaneous tissue disorders	—
Abdominal pain upper	Gastrointestinal disorders	—
Dyspepsia	Gastrointestinal disorders	—
Non-cardiac chest pain	General disorders	—
Oedema peripheral	General disorders	—
Pneumonia	Infections and infestations	—
Sinusitis	Infections and infestations	—
Weight decreased	Investigations	—
Dehydration	Metabolism and nutrition disorders	—
Hypomagnesaemia	Metabolism and nutrition disorders	—

Most-reported serious reactions: Vomiting, Dehydration, Syncope, Diarrhoea, Nausea, Rectal haemorrhage, Pneumonia, Urinary tract infection.

Data from ClinicalTrials.gov NCT02514174 adverse events section.

Sponsor's own description

Continuous treatment until progression or occurence of intolerable Adverse Event (AE) or end of trial. The end of trial is one year after the last patient has entered the study.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Therapeutic targeting of anoikis resistance in cutaneous melanoma metastasis.
   Neuendorf HM, Simmons JL, Boyle GM. · · 2023 · cited 18× · PMID 37181747 · DOI 10.3389/fcell.2023.1183328
2. Anoikis resistance in Cancer: Mechanisms, therapeutic strategies, potential targets, and models for enhanced understanding.
   Shaw P, Dey Bhowmik A, Gopinatha Pillai MS, Robbins N, et al · · 2025 · cited 11× · PMID 40294841 · DOI 10.1016/j.canlet.2025.217750