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

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.

Study Overview

• Status: Completed
• Conditions: Non-squamous, Non-Small Cell Lung Cancer
• Intervention / Treatment: Drug: afatinib

• Study Type: Observational
• Enrollment (Actual): 805

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan, 141-6017
    • Nippon Boehringer Ingelheim Co., Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
patients treated with afatinib	Drug: afatinib; afatinib; Other Names: Giotrif®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From start of afatinib as first line treatment up to 18 months and up to 36 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time on Treatment From the Start of Afatinib Until End of Subsequent Therapies in the Second-line Setting or Death by Any Cause (TOT)	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.	From start of afatinib 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)	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.	From start of afatinib as second line treatment up to 18 months and up to 36 months.
Overall Survival	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.	From start of afatinib up to 18 months and up to 36 months.
Time to Initial Dose Reduction of Afatinib	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.	From start of afatinib up to 18 months and up to 36 months.
Percentage of Participants With Dose Modifications of Afatinib	Percentage of participants with dose modifications of afatinib.	From start of data extraction until end of data extraction, up to 586 days.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2021
• Primary Completion (Actual): October 16, 2023
• Study Completion (Actual): October 16, 2023

Study Registration Dates

• First Submitted: March 9, 2021
• First Submitted That Met QC Criteria: March 9, 2021
• First Posted (Actual): March 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 19, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma; Adenocarcinoma of Lung; Adenocarcinoma; Tyrosine Kinase Inhibitors; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Afatinib
• Other Study ID Numbers: 1200-0322

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No