Clinical trial NCT04795245: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-squamous, Non-Small Cell Lung Cancer
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 805
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients who were treated with afatinib in the first-line setting in each study site after the launch of Giotrif® on 7 May 2014 on a regular basis; their information will be chosen.

Deceased patients fulfilling the eligibility criteria should be enrolled whenever possible.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1)
timeFrame: From start of afatinib as first line treatment up to 18 months and up to 36 months.
Secondary outcomes:
measure: Time on Treatment From the Start of Afatinib Until End of Subsequent Therapies in the Second-line Setting or Death by Any Cause (TOT)
timeFrame: From start of afatinib up to 18 months and up to 36 months.
measure: Time on Treatment From Start of the Second-line Treatment Until End of the Second-line Treatment or Death by Any Cause (TOT2)
timeFrame: From start of afatinib as second line treatment up to 18 months and up to 36 months.
measure: Overall Survival
timeFrame: From start of afatinib up to 18 months and up to 36 months.
measure: Time to Initial Dose Reduction of Afatinib
timeFrame: From start of afatinib up to 18 months and up to 36 months.
measure: Percentage of Participants With Dose Modifications of Afatinib
timeFrame: From start of data extraction until end of data extraction, up to 586 days.
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nippon Boehringer Ingelheim Co., Ltd.
Study officials:
References: