Real World Data on Gi(l)Otrif® Dose Adjustment

June 24, 2019 updated by: Boehringer Ingelheim

Real-world Data on Gi(l)Otrif® Dose Adjustment in First-line Treatment, TKI-naïve, Advanced Non-small Cell Lung Cancer Patients With EGFR Activating Mutations

This is a non-interventional, multi-country, multi-site study based on existing data from medical records of patients treated with Gi(l)otrif® as part of the routine treatment according to the approved label. Data from real-world will help to understand if dose modifications are done similar as in LUX-Lung 3 trial and if the outcome on safety and effectiveness are as in trial settings. Furthermore, data on modified starting doses, the underlying reasons and effects on safety and outcome are needed.

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.

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.
228

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

  • Austria
      • Wien, Austria, 1140
        • SMZ Baumgartner Hoehe Otto Wagner Spital
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency - Vancouver
  • France
      • Besancon, France, 25030
        • HOP Jean Minjoz
      • Dijon Cedex, France, 21079
        • HOP Dijon, Cardio-Pneumo, Dijon
      • Paris, France, 75908
        • HOP Européen G. Pompidou
      • Paris, France, 75970
        • HOP Tenon
  • Germany
      • Essen, Germany, 45147
        • Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
      • Nürnberg, Germany, 90419
        • Klinikum Nürnberg
      • Oldenburg, Germany, 26121
        • Pius-Hospital, Oldenburg
  • Italy
      • Alessandria, Italy, 15121
        • Azienda ospedaliera Santi Antonio e Biagio e Cesare Arrigo
      • Lecce, Italy, 73100
        • Azienda Ospedaliera Vito Fazzi
  • Japan
      • Aichi, Nagoya, Japan, 464-8681
        • Aichi Cancer Center Hospital
      • Okayama, Kurashiki, Japan, 710-8602
        • Kurashiki Central Hospital
  • Korea, Republic of
      • Daegu, Korea, Republic of, 705-703
        • Yeungnam University Medical Center
      • Jeonju, Korea, Republic of, 54907
        • Chonbuk National University Hospital
      • Pusan, Korea, Republic of, 49241
        • Pusan National Univ. Hosp
  • Mexico
      • Ciudad De México, Mexico, 01120
        • Centro Médico ABC
      • Monterrey, Mexico, 64060
        • Organización para Cuidado Integral en Oncología S.A de C.V
      • Zapopan, Mexico, 45050
        • Unidad de Cancerologia
  • Poland
      • Bydgoszcz, Poland, 85796
        • Medical Practice,Bogdan Zurawski,Private Practice,Bydgoszcz
      • Cracow, Poland, 31331
        • Grzegorz Czyzewicz Specialised Medical Practice, Cracow
      • Poznan, Poland, 60-569
        • Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland
  • Singapore
      • Singapore, Singapore, 169610
        • National Cancer Centre
      • Singapore, Singapore, 119228
        • National University Hospital
  • Spain
      • Badalona (Barcelona), Spain, 08916
        • Hospital Germans Trías i Pujol
      • Madrid, Spain, 28006
        • Hospital La Princesa
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28201
        • Levine Cancer Institute

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

Non-Probability Sample

Study Population

NSCLC patients

Description

Inclusion criteria:

  1. Age = 18 years
  2. Patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), tyrosine kinase inhibitors (TKI)-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label
  3. Signed and dated written informed consent per regulations. (Exemption of a written informed consent for retrospective observational studies in some countries per local regulations and legal requirements.)

Exclusion criteria:

  1. Any contraindication to Gi(l)otrif® as specified in label.
  2. Patients with uncommon mutations are excluded as uncommon mutations are not within label in all participating countries (e.g. USA).
  3. Patients still on treatment with Gi(l)otrif® will be excluded unless treatment period is > or = 6 months.
  4. Patients treated with Gi(l)otrif® within an interventional trial.

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.
Non small cell lung cancer (NSCLC)
patients with Epidermal growth factor receptor (EGFR) mutation (common mutations), TKI-naïve advanced non small cell lung cancer (NSCLC), treated with Gi(l)otrif® as the first-line treatment for NSCLC within the approved label

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
Percentage of Patients With Adverse Drug Reactions (ADR) by Severity Class.
Time Frame: From signing the informed consent onwards until the end of the study, up to 104 weeks.
An adverse drug reaction (ADR) is defined as a response to a medicinal product which is noxious and unintended. Grade 1, Grade 2, Grade 3 and Grade 4 ADR severity classes were considered for assessment of this outcome.
From signing the informed consent onwards until the end of the study, up to 104 weeks.
Time on Treatment With Gi(l)Otrif®
Time Frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Time on treatment with Gi(l)otrif® in real-world setting has been calculated in this assessment. Time on treatment refers to time to treatment failure with Gi(l)otrif®
From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Time to Progression With Gi(l)Otrif®
Time Frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Time to progression was calculated from the date of first dose of Gi(l)otrif® treatment to the earliest date of documented progression (clinical, radiographic or both clinical/radiographic progression) or tumour-related death, whatever occurred first.
From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.

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
Percentage of Patients With a Modified Starting Dose of Gi(l)Otrif®
Time Frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Percentage of patients with a modified starting dose that is dose other than the recommended 40 mg daily of Gi(l)otrif® has been calculated to assess this outcome measure.
From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Percentage of Patients With Reasons for Modified Starting Dose of Gi(l)Otrif®
Time Frame: From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.
Different reasons for starting dose with modified dose that is dose other than recommended 40 mg once daily.
From first dose of Gi(l)otrif® treatment to last dose of Gi(l)otrif® treatment, up to 104 weeks.

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.

General Publications

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.
November 24, 2016

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.
September 30, 2017

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.
September 30, 2017

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).
April 22, 2016

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.
April 22, 2016

First Posted (Estimate)

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.
April 26, 2016

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.
August 8, 2019

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 24, 2019

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, 2019

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.
  • 1200.270

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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