Retrospective Multi-cohort Study of Frontline Afatinib Followed by 2nd Line Therapy Including Osimertinib, Chemotherapy or Other Therapy

June 13, 2021 updated by: Jin Hyoung Kang, Seoul St. Mary's Hospital

Totality Outcome of Afatinib Sequential Treatment in Patients With EGFR Sensitizing Mutation-positive NSCLC in South Korea

The T790M mutation is highly sensitive to osimertinib, which is approved in this setting following failure of gefitinib, erlotinib or afatinib. In contrast to first- and second-generation EGFR TKIs, no predominant resistance mechanism to first-line osimertinib has been clearly defined yet. The most common mechanisms of resistance were c-MET amplification only for 15% of patients and the emergence of the EGFR C797S mutation in 7%, while > 60% of patients were still with no identifiable mechanisms of resistance. As a result, targeted treatment options following first-line osimertinib failure remain limited. Thus, interest on sequential administration of EGFR TKIs in patients with EGFR mutation-positive NSCLC has been growing. So, here in this study, we intend to investigate treatment outcome (TOT) along with the several treatment options starting from the first line EGFR TKI treatment to various second line treatments including 3rd generation TKI and chemotherapy and others.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

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.
737

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

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

non-interventional, multi-center, multi-cohort

Description

Inclusion Criteria:

  1. Age more than 18 years
  2. Stage IIIB/IIIC/IV/IVA/IVB NSCLC patients treated with first-line afatinib for EGFR sensitizing mutations (Del19, L858R, G719X, S768I, or L861Q etc.)
  3. Afatinib treatment was started 13 month prior to data collection date to reduce premature censoring of patients. Data cutoff date will be determined before data entry starts.

Exclusion Criteria:

  1. Patients who received drug(s) other than afatinib (Giotrif®) as the first-line treatment
  2. Patients who received drug(s) other than 3rd-generation EGFR TKI osimertinib as the second-line in "Cohort A'

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

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.
Cohort A
T790M+ patients sequentially treated with osimertinib in cohort A
Drug: Gilotrif
This is non-interventional, multi-center, multi-cohort study based on existing data from EGFR sensitizing mutation-positive NSCLC patients treated with afatinib as the first-line treatment. Enrolled patients will be categorized into four cohorts (cohort A, B, C and D) according to the type of second line treatment with biopsy results before start of second line treatment.
Cohort B
T790M- patients treated with chemotherapy or other treatments in cohort B
Drug: Gilotrif
This is non-interventional, multi-center, multi-cohort study based on existing data from EGFR sensitizing mutation-positive NSCLC patients treated with afatinib as the first-line treatment. Enrolled patients will be categorized into four cohorts (cohort A, B, C and D) according to the type of second line treatment with biopsy results before start of second line treatment.
Cohort C
patients with unknown mutation status in cohort C
Drug: Gilotrif
This is non-interventional, multi-center, multi-cohort study based on existing data from EGFR sensitizing mutation-positive NSCLC patients treated with afatinib as the first-line treatment. Enrolled patients will be categorized into four cohorts (cohort A, B, C and D) according to the type of second line treatment with biopsy results before start of second line treatment.
Cohort D
Cohort D included patients who were still ongoing with afatinib.
Drug: Gilotrif
This is non-interventional, multi-center, multi-cohort study based on existing data from EGFR sensitizing mutation-positive NSCLC patients treated with afatinib as the first-line treatment. Enrolled patients will be categorized into four cohorts (cohort A, B, C and D) according to the type of second line treatment with biopsy results before start of second line treatment.

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
Total TOT
Time Frame: Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).
the time on treatment (total TOT) of EGFR M+ NSCLC patients treated with afatinib in the first-line (TOT-1) followed by second line treatments(TOT-2) including osimertinib, chemotherapy and other treatments.
Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).

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
Time Frame
objective response rate (ORR-1 & ORR-2's)
Time Frame: Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).
Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).
overall survival time
Time Frame: Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).
Non-interventional study (NIS) based on the existing data from patients' medical records(2013-08-01 ~ 2029-04-30).

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.
Seoul St. Mary's Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boehringer Ingelheim

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.
February 24, 2020

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.
December 17, 2020

Study Completion (ANTICIPATED)

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.
September 30, 2021

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).
June 13, 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.
June 13, 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.
June 18, 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.
June 18, 2021

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.
June 13, 2021

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.
June 1, 2021

More Information

Terms related to this study

Keywords

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.
  • TOAST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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