Trial Outcomes & Findings for The Study Observes Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer (NCT NCT04206787)
NCT ID: NCT04206787
Last Updated: 2025-02-28
Results Overview
Time on Treatment (TOT) is defined as the median time a patient is under first-line afatinib treatment before being treated with third generation EGFR tyrosine kinase inhibitors (TKI) or other subsequent treatment, starting from the first dose of afatinib treatment until the last first-line dose or death by any cause, whichever comes first. Patients that were lost to follow up, withdrew before the end of study or received first-line afatinib at the end of the study were censored at the time of last known contact of first line afatinib. The median TOT was calculated using the Kaplan Mayer method and the 90% confidence interval was calculated using the Brookmeyer-Crowley method.
Recruitment status
COMPLETED
Target enrollment
72 participants
Primary outcome timeframe
From first afatinib administration until last first-line afatinib administration, censoring date or death. Up to approximately 40 months.
Results posted on
2025-02-28
Participant Flow
Non-interventional, prospective, multicentre study based on real-world data of Chinese EGFR-mutated non-small cell-lung cancer (NSCLC) patients treated with afatinib as first-line treatment and receive subsequent therapy.
Only subjects that met all inclusion and none of the exclusion criteria were included. Patients were followed until death, lost to follow-up, withdraw from the study, or end of the study for other reasons, whichever came first and no later than 22-Dec-2023.
Participant milestones
| Measure |
Afatinib-treated Patients
Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.
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|---|---|
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Overall Study
STARTED
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72
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Overall Study
Treated
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72
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Overall Study
COMPLETED
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26
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Overall Study
NOT COMPLETED
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46
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Reasons for withdrawal
| Measure |
Afatinib-treated Patients
Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.
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|---|---|
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Overall Study
Other than listed
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2
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Overall Study
Investigator decision
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1
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Overall Study
Death
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25
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Overall Study
Lost to Follow-up
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9
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Overall Study
Withdrawal of consent
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9
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Baseline Characteristics
The Study Observes Afatinib as First-line Treatment in Patients With Epidermal Growth Factor Receptor (EGFR) Mutation-positive Advanced Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Afatinib-treated Patients
n=72 Participants
Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.
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|---|---|
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Age, Continuous
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62.2 Years
STANDARD_DEVIATION 9.61 • n=5 Participants
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Sex: Female, Male
Female
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33 Participants
n=5 Participants
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Sex: Female, Male
Male
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39 Participants
n=5 Participants
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Race/Ethnicity, Customized
Chinese
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71 Participants
n=5 Participants
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Race/Ethnicity, Customized
Other
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1 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: From first afatinib administration until last first-line afatinib administration, censoring date or death. Up to approximately 40 months.Population: Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
Time on Treatment (TOT) is defined as the median time a patient is under first-line afatinib treatment before being treated with third generation EGFR tyrosine kinase inhibitors (TKI) or other subsequent treatment, starting from the first dose of afatinib treatment until the last first-line dose or death by any cause, whichever comes first. Patients that were lost to follow up, withdrew before the end of study or received first-line afatinib at the end of the study were censored at the time of last known contact of first line afatinib. The median TOT was calculated using the Kaplan Mayer method and the 90% confidence interval was calculated using the Brookmeyer-Crowley method.
Outcome measures
| Measure |
Afatinib-treated Patients
n=72 Participants
Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.
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|---|---|
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Time on Treatment of Afatinib as First-line Therapy in Advanced Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
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14.4 Months
Interval 11.27 to 18.07
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SECONDARY outcome
Timeframe: From first afatinib administration until death, or censoring date. Up to approximately 41 months.Population: Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
Overall survival (OS) is defined as the time from the start of afatinib until death for any reason. Subjects who have not died at the time of the statistical analysis were censored at the time they had the last known afatinib contact. The median survival time was calculated using the Kaplan Mayer method and the 90% confidence interval was calculated using the Brookmeyer-Crowley method. The median OS was not estimable due to the limited number of death events.
Outcome measures
| Measure |
Afatinib-treated Patients
n=72 Participants
Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.
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|---|---|
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Overall Survival (OS) From the Start of Afatinib Until the End of Study, Date of Death, Patient Withdrawal or Loss to Follow-up
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NA Months
Interval 28.32 to
Not estimable due to limited number of death events.
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SECONDARY outcome
Timeframe: From first afatinib administration until earliest RECIST progression (progressive disease (PD) or death) or the last evaluable assessment in the absence of RECIST progression (PD or death). Up to approximately 40 months.Population: Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib. Patients without tumor assessment data were excluded from the analysis.
The objective response rate (ORR) is defined as the percentage of subjects treated with first-line afatinib with best overall response of complete response (CR), defined by the disappearance of all target lesions, and partial response (PR), defined by a decrease of at least 30% in the sum of the diameter of target lesions taking the baseline sum diameters as reference. The tumor response was evaluated by the investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. The Clopper-Pearson method was used to provide an estimation of the ORR with 95% confidence interval.
Outcome measures
| Measure |
Afatinib-treated Patients
n=67 Participants
Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.
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|---|---|
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Objective Response Rate (ORR) According to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 by Investigator Review With Afatinib in First-line Treatment
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62.7 Percentage of participants
Interval 50.01 to 74.2
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SECONDARY outcome
Timeframe: From signing the informed consent form until 30 days after last dose of afatinib. Up to approximately 43 months.Population: Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
Number of patients treated with first-line afatinib with any adverse event.
Outcome measures
| Measure |
Afatinib-treated Patients
n=72 Participants
Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.
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|---|---|
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Number of Patients With Any Adverse Event (AE)
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68 Participants
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SECONDARY outcome
Timeframe: From first afatinib administration to 30 days after last dose of afatinib. Up to approximately 41 months.Population: Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
Number of patients treated with first-line afatinib with treatment emergent serious adverse events (SAEs). SAEs are untoward medical occurrences that result in death, are life threatening, require inpatient hospitalisation, require prolongation of existing hospitalisation, result in persistent or significant disability/incapacity, result in a congenital anomaly/birth defect, or are deemed serious for any other medically important reason.
Outcome measures
| Measure |
Afatinib-treated Patients
n=72 Participants
Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.
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Number of Patients With Treatment-emergent Serious Adverse Events (SAE)
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10 Participants
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SECONDARY outcome
Timeframe: From first afatinib administration to 30 days after last dose of afatinib. Up to approximately 41 months.Population: Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
Number of patients treated with first-line afatinib with any adverse event associated with the use of afatinib.
Outcome measures
| Measure |
Afatinib-treated Patients
n=72 Participants
Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.
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|---|---|
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Number of Patients With Any Afatinib-related Adverse Events (AE)
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63 Participants
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Adverse Events
Afatinib-treated Patients
Serious events: 10 serious events
Other events: 65 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Afatinib-treated Patients
n=72 participants at risk
Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.
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|---|---|
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Gastrointestinal disorders
Nausea
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1.4%
1/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Gastrointestinal disorders
Oesophageal varices haemorrhage
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1.4%
1/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Gastrointestinal disorders
Upper gastrointestinal haemorrhage
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1.4%
1/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Gastrointestinal disorders
Vomiting
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1.4%
1/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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General disorders
Death
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1.4%
1/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Infections and infestations
COVID-19
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1.4%
1/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Infections and infestations
Pneumonia
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1.4%
1/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Metabolism and nutrition disorders
Decreased appetite
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1.4%
1/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
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1.4%
1/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Nervous system disorders
Transient ischaemic attack
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1.4%
1/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Respiratory, thoracic and mediastinal disorders
Pleural effusion
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2.8%
2/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Respiratory, thoracic and mediastinal disorders
Respiratory failure
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1.4%
1/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Other adverse events
| Measure |
Afatinib-treated Patients
n=72 participants at risk
Chinese patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer who initiated afatinib as first-line treatment. Patients received either 30 milligrams (mg) or 40 mg tablet of afatinib once daily as indicated in the approved label for the drug or any other subsequent therapy.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
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9.7%
7/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Gastrointestinal disorders
Diarrhoea
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73.6%
53/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Gastrointestinal disorders
Mouth ulceration
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47.2%
34/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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General disorders
Pyrexia
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5.6%
4/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Hepatobiliary disorders
Hepatic function abnormal
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8.3%
6/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Infections and infestations
Paronychia
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31.9%
23/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Investigations
Alanine aminotransferase increased
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9.7%
7/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Investigations
Aspartate aminotransferase increased
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8.3%
6/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
|
|
Metabolism and nutrition disorders
Decreased appetite
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5.6%
4/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
9.7%
7/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Nervous system disorders
Headache
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5.6%
4/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Respiratory, thoracic and mediastinal disorders
Cough
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6.9%
5/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
9.7%
7/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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|
Skin and subcutaneous tissue disorders
Rash
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50.0%
36/72 • All-cause mortality: From first afatinib administration until individual end of study. Up to approximately 43 months. Treatment-emergent adverse event reporting: From first afatinib administration until last afatinib administration plus 30 days residual effect period (REP). Up to approximately 41 months.
Treated set: all patients who were dispensed medication and were documented to have taken at least one dose of first-line treatment afatinib.
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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