Non-squamous, Non-Small Cell Lung Cancer
Conditions
Brief summary
This study aims to observe the sequential strategy with afatinib as first-line treatment and to find the optimal treatment strategy for long-term chemotherapy-free regimens in Chinese patients with EGFR-mutated advanced NSCLC. Furthermore, this study can also assess the effectiveness and safety of afatinib as first-line treatment.
Interventions
DRUGAfatinib
drug
Sponsors
Boehringer Ingelheim
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who are diagnosed with locally advanced or metastatic NSCLC with EGFR sensitive mutation positive * Patients who will initiate afatinib as first-line treatment for EGFR mutation-positive NSCLC * Male and female patients with age ≥18 years * Written informed consent per local regulatory requirement
Exclusion criteria
* Patients who have received previous systemic therapy (previous adjuvant or neoadjuvant therapies are permitted) * Patients with symptomatic brain metastases (patients with brain metastases, who were previously treated, are eligible provided they have asymptomatic brain metastasis for at least 4 weeks on stable doses of medication) at the start of afatinib treatment * Patients with concurrent participation in an interventional oncology clinical trial during the first-line treatment phase or within the last 30 days prior to the first-line treatment phase. If patients join another interventional study during the period of second-line treatment or later-line treatment, this patient should not be excluded from this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time on Treatment of Afatinib as First-line Therapy in Advanced Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation | From first afatinib administration until last first-line afatinib administration, censoring date or death. Up to approximately 40 months. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) From the Start of Afatinib Until the End of Study, Date of Death, Patient Withdrawal or Loss to Follow-up | From first afatinib administration until death, or censoring date. Up to approximately 41 months. | 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. |
| 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 | 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. | 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. |
| Number of Patients With Any Adverse Event (AE) | From signing the informed consent form until 30 days after last dose of afatinib. Up to approximately 43 months. | Number of patients treated with first-line afatinib with any adverse event. |
| Number of Patients With Treatment-emergent Serious Adverse Events (SAE) | From first afatinib administration to 30 days after last dose of afatinib. Up to approximately 41 months. | 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. |
| Number of Patients With Any Afatinib-related Adverse Events (AE) | From first afatinib administration to 30 days after last dose of afatinib. Up to approximately 41 months. | Number of patients treated with first-line afatinib with any adverse event associated with the use of afatinib. |
Countries
China
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 25 |
| Overall Study | Investigator decision | 1 |
| Overall Study | Lost to Follow-up | 9 |
| Overall Study | Other than listed | 2 |
| Overall Study | Withdrawal of consent | 9 |
Baseline characteristics
| Characteristic | Afatinib-treated Patients |
|---|---|
| Age, Continuous | 62.2 Years STANDARD_DEVIATION 9.61 |
| Race/Ethnicity, Customized Chinese | 71 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 25 / 72 |
| other Total, other adverse events | 65 / 72 |
| serious Total, serious adverse events | 10 / 72 |
Outcome results
Primary
Time on Treatment of Afatinib as First-line Therapy in Advanced Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Afatinib-treated Patients | Time on Treatment of Afatinib as First-line Therapy in Advanced Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor (EGFR) Mutation | 14.4 Months |
Secondary
Number of Patients With Any Adverse Event (AE)
Number of patients treated with first-line afatinib with any adverse event.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Afatinib-treated Patients | Number of Patients With Any Adverse Event (AE) | 68 Participants |
Secondary
Number of Patients With Any Afatinib-related Adverse Events (AE)
Number of patients treated with first-line afatinib with any adverse event associated with the use of afatinib.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Afatinib-treated Patients | Number of Patients With Any Afatinib-related Adverse Events (AE) | 63 Participants |
Secondary
Number of Patients With Treatment-emergent Serious Adverse Events (SAE)
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Afatinib-treated Patients | Number of Patients With Treatment-emergent Serious Adverse Events (SAE) | 10 Participants |
Secondary
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
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Afatinib-treated Patients | 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 | 62.7 Percentage of participants |
Secondary
Overall Survival (OS) From the Start of Afatinib Until the End of Study, Date of Death, Patient Withdrawal or Loss to Follow-up
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.
Time frame: 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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Afatinib-treated Patients | Overall Survival (OS) From the Start of Afatinib Until the End of Study, Date of Death, Patient Withdrawal or Loss to Follow-up | NA Months |