Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02751879
Recruitment Status : Completed
First Posted : April 26, 2016
Results First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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.

Condition or disease
Carcinoma, Non-Small-Cell Lung

Layout table for study information
Study Type : Observational
Actual Enrollment : 228 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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
Actual Study Start Date : November 24, 2016
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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.

  2. 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®

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
NSCLC patients
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02751879


  Show 29 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Study Protocol  [PDF] March 1, 2016
Statistical Analysis Plan  [PDF] January 17, 2018


Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02751879     History of Changes
Other Study ID Numbers: 1200.270
First Posted: April 26, 2016    Key Record Dates
Results First Posted: August 8, 2019
Last Update Posted: August 8, 2019
Last Verified: June 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases