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

December 19, 2024 updated by: Boehringer Ingelheim

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
805

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients treated with afatinib
Drug: afatinib
afatinib
Other Names:
  • Giotrif®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time on Treatment (TOT) With Afatinib in First-line TOT (TOT1)
Time Frame: 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.
From start of afatinib as first line treatment up to 18 months and up to 36 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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 Frame: 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.
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 Frame: 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.
From start of afatinib as second line treatment up to 18 months and up to 36 months.
Overall Survival
Time Frame: 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.
From start of afatinib up to 18 months and up to 36 months.
Time to Initial Dose Reduction of Afatinib
Time Frame: 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.
From start of afatinib up to 18 months and up to 36 months.
Percentage of Participants With Dose Modifications of Afatinib
Time Frame: From start of data extraction until end of data extraction, up to 586 days.
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 26, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 16, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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