Non-interventional Study for Real-world Data of Afatinib Treatment in First-line Setting and of Subsequent Therapies for Patients With Advanced Epidermal Growth Factor Receptor (EGFR) Mutation-positive Lung Adenocarcinoma

J-REGISTER: Japanese REal-world Data for Treatment of Afatinib (GIotrif®) in First-line Setting and Subsequent Therapies for Patients With Advanced EGFR Mutation-positive Lung Adenocarcinoma

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04795245

Enrollment

805

Registered

2021-03-12

Start date

2021-08-26

Completion date

2023-10-16

Last updated

2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-squamous, Non-Small Cell Lung Cancer

Brief summary

The primary objective is to confirm Time on Treatment (TOT) related to afatinib treatment as first-line therapy in patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive Non-Small Cell Lung Cancer (NSCLC). The observation in the real-world setting of the time from the start of the first-line afatinib until the end of subsequent treatment in this study will provide insights on the sequence of treatment for patients. The Japanese healthcare system will enable this study to evaluate multiple treatment options after afatinib treatment.

Interventions

DRUGafatinib

afatinib

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with Epidermal Growth Factor Receptor (EGFR) mutation-positive advanced Non-Small Cell Lung Cancer (NSCLC) * Patients who were/are treated with afatinib in the first-line setting at least 20 months\* prior to data entry * Patients 20 years of age or older at the time of consent * Patients who provided consent to participate in this study (for cases of death or lost to follow-up, instructions from the Ethic Committee (EC)/Institutional Review Board (IRB) at each site should be followed) \* Inclusion will be restricted to patients with treatment initiation with afatinib at least 20 months prior to enrolment to avoid early censoring.

Exclusion criteria

* Any contraindication to afatinib as specified in the label of Giotrif® * Patients treated with afatinib within an interventional trial * Patients with active brain metastases at start of afatinib treatment\* \* Patients with non-active brain metastases (asymptomatic state) are eligible.

Design outcomes

Primary

Measure	Time frame	Description
Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1)	From start of afatinib as first line treatment up to 18 months and up to 36 months.	Time on Treatment (TOT) with afatinib in first-line TOT (TOT1). This was assessed as the time from the start of afatinib as first-line treatment until the end of afatinib treatment or death date by any cause, whichever occurs first. If patients did not discontinue first-line treatment with afatinib and did not die at the data extraction, they were censored on the date they were last verified to have been on first-line treatment with afatinib. The survival probability rate (95% confidence interval) against time to first-line treatment failure at 18 months and at 36 months is reported.

Secondary

Measure	Time frame	Description
Time on Treatment From the Start of Afatinib Until End of Subsequent Therapies in the Second-line Setting or Death by Any Cause (TOT)	From start of afatinib up to 18 months and up to 36 months.	Time on treatment from the start of afatinib until end of subsequent therapies in the second-line setting or death by any cause (TOT). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. If patients were on first-line treatment and did not move to second-line treatment at the data extraction, ToT is same as first-line TOT (ToT1) for these patients. The survival probability rate (95% confidence interval) against time to treatment failure at 18 months and at 36 months is reported.
Time on Treatment From Start of the Second-line Treatment Until End of the Second-line Treatment or Death by Any Cause (TOT2)	From start of afatinib as second line treatment up to 18 months and up to 36 months.	Time on treatment from start of the second-line treatment until end of the second-line treatment or death by any cause (TOT2). If patients did not discontinue second-line treatment and did not die at the data extraction, they were censored on the date they are last verified to have been on second-line treatment. The survival probability rate (95% confidence interval) against time to second-line treatment failure at 18 months and at 36 months is reported.
Overall Survival	From start of afatinib up to 18 months and up to 36 months.	If patients did not die at the data extraction, they were censored on the date they are last verified to be alive. The survival probability rate (95% confidence interval) at 18 months and at 36 months is reported.
Time to Initial Dose Reduction of Afatinib	From start of afatinib up to 18 months and up to 36 months.	Time to initial dose reduction of afatinib. If patients did not reduce initial dose of afatinib at the data extraction, they were censored on the date they were last verified to have been on the initial dose of afatinib or increased dose of afatinib. The survival probability rate (95% confidence interval) against time to initial dose reduction of afatinib at 18 months and 36 months is reported.
Percentage of Participants With Dose Modifications of Afatinib	From start of data extraction until end of data extraction, up to 586 days.	Percentage of participants with dose modifications of afatinib.

Countries

Japan

Participant flow

Recruitment details

Non-interventional, multi-center study from existing data of patients treated with afatinib as the first-line treatment. 40 study sites in Japan were planned for participating. Recruitment of patients was stopped at all sites when it was determined that a sufficient number of patients have been enrolled. A maximum of 50 patients were limited for enrolment per site to avoid differential study site influence on study results. Data extraction started on 01 April 2021 and ended on 07 November 2022.

Pre-assignment details

Only subjects that met all inclusion and none of the exclusion criteria were included.

Participants by arm

Arm	Count
Patients Treated With Afatinib Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®).	805
Total	805

Arm

Count

Patients Treated With Afatinib

Patients with epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) treated with afatinib as the first-line treatment during the period from launch of afatinib (7 May 2014) to at least 20 months prior to the time point of enrolment of patients (first round) and follow-up data was extracted for the same patients one year after completion of first round during the study period (second round). Patients were treated with 20, 30, 40 or 50 milligram (mg) tablet of afatinib once daily as indicated in the approved label of afatinib (Giotrif®).

805

Total

805

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	143
Overall Study	Death	17
Overall Study	Other than listed	19
Overall Study	Progressive disease	512
Overall Study	Unknown if patients were still on treatment at end of observation period	22
Overall Study	Unkown reason	7

Baseline characteristics

Characteristic	Patients Treated With Afatinib
Age, Continuous	65.8 Years STANDARD_DEVIATION 10.5
Race/Ethnicity, Customized Japanese	799 Participants
Race/Ethnicity, Customized Non-Asian	2 Participants
Race/Ethnicity, Customized Other Asian	4 Participants
Sex: Female, Male Female	440 Participants
Sex: Female, Male Male	365 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	486 / 805
other Total, other adverse events	43 / 805
serious Total, serious adverse events	8 / 805

Outcome results

Primary

Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1)

Time on Treatment (TOT) with afatinib in first-line TOT (TOT1). This was assessed as the time from the start of afatinib as first-line treatment until the end of afatinib treatment or death date by any cause, whichever occurs first. If patients did not discontinue first-line treatment with afatinib and did not die at the data extraction, they were censored on the date they were last verified to have been on first-line treatment with afatinib. The survival probability rate (95% confidence interval) against time to first-line treatment failure at 18 months and at 36 months is reported.

Time frame: From start of afatinib as first line treatment up to 18 months and up to 36 months.