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

Non-squamous, Non-Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04795245
• Other study ID #: 1200-0322
• Status: Completed
• Start date: August 26, 2021
• Est. completion date: October 16, 2023

Study information

• Verified date: October 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 857
• Est. completion date: October 16, 2023
• Est. primary completion date: October 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Lung
• Non-squamous, Non-Small Cell Lung Cancer

Intervention

Drug:
• afatinib
afatinib

Locations

Country	Name	City	State
Japan	Nippon Boehringer Ingelheim Co., Ltd.	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time on Treatment (TOT) with afatinib in first-line TOT (TOT1)	This will be 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.	up to 48 months
Secondary	TOT from the start of afatinib until end of subsequent therapies in the second-line setting or death by any cause		up to 48 months
Secondary	TOT from start of the second-line treatment until end of the second-line treatment or death by any case (TOT2)		up to 48 months
Secondary	overall survival		at month 18 and at month 36
Secondary	survival rate		at month 18 and at month 36
Secondary	time to initial dose reduction of afatinib		up to 48 months
Secondary	proportion of patients with dose modifications of afatinib		up to 48 months

External Links

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