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Afatinib Osimertinib Sequencing NIS

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: NCT03370770
Recruitment Status : Completed
First Posted : December 12, 2017
Results First Posted : December 24, 2020
Last Update Posted : December 24, 2020
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
This is a non-interventional, multi-country, multi-centre cohort study based on existing data from medical records of patients with EGFR mutation-positive advanced NSCLC treated with afatinib (Gi(l)otrif®) as the first-line treatment followed by osimertinib in case the T790M resistance mutation was developed.

Condition or disease Intervention/treatment
Carcinoma, Non-Small-Cell Lung Drug: Afatinib Drug: Osimertinib

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Study Type : Observational
Actual Enrollment : 204 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: GioTag: Real-world Data Study on Sequential Therapy With Gi(l)Otrif®/ Afatinib as First-line Treatment Followed by Osimertinib in Patients With EGFR Mutation Positive Advanced Non-small Cell Lung Cancer
Actual Study Start Date : December 28, 2017
Actual Primary Completion Date : November 28, 2019
Actual Study Completion Date : November 28, 2019

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
patients with EGFR mutation-positive NSCLC
(Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)
Drug: Afatinib

Drug: Osimertinib
on T790M resistance mutation was developed

Primary Outcome Measures :
  1. Time on Treatment With Afatinib (Gi(l)Otrif®) Followed by Osimertinib [ Time Frame: Data collected from start of treatment until data entry completion, up to 96.8 months for first analysis and up to 114.1 months for the extension analysis. ]

    Time on treatment, which was defined as time in months from the start date of Afatinib (Gi[l]otrif®) treatment ('start date of initial dose' for First-Line Treatment) to the end date of Osimertinib treatment (maximum between 'end date of initial dose' and the last 'end date of dose modification' for Second-Line Treatment) or death date due to any cause ('date of death').

    Time on treatment (months) = Time on treatment (days)/30.4375.

    'Time on treatment was analysed using Kaplan-Meier method, and the median along with two-sided 90% confidence interval was displayed using the Greenwood's formula for estimation of standard errors.

Secondary Outcome Measures :
  1. The Percentage of Participants With Different Types of Mutations After Categorisation [ Time Frame: Data collected from start of treatment until data entry completion; up to 96.8 months. ]
    Different types of resistance mutations identified at the time of discontinuation of osimertinib treatment were systematically reviewed and categorised.

Information from the National Library of Medicine

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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
Study is planned that around 65 study centres in 11 countries will be participating in this noninterventional study and at least 190 consecutive eligible patients will be enrolled to the study. Every patient who fulfils inclusion and exclusion criteria and agree to participate in the study (if a written informed consent is required for this NIS by local regulation and legal requirement) will be selected until the required sample size is achieved.

Inclusion Criteria:

  • Patients with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC)
  • The tumour harbours common EGFR mutations (Del19, L858R) at start of first-line treatment
  • Patients who initiated second-line osimertinib treatment for acquired T790M mutation at least 10 months prior to data entry, AND who were treated with afatinib (Gi(l)otrif®) in the first-line
  • Patients treated with osimertinib within an EAP/CUP or regular clinical practice
  • Age ≥ 18 years
  • Signed and dated written informed consent per regulations (Exemption of a written informed consent for NIS based on existing data in countries per local regulations and legal requirements)

Exclusion Criteria:

  • Patients who received drug(s) other than osimertinib as the second-line treatment and/or patients who received drug(s) other than afatinib (Gi(l)otrif®) as the first-line treatment
  • Patients with active brain metastases at start of treatment (either afatinib/Gi(l)otrif® or osimertinib)

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): NCT03370770

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Otto-Wagner Hospital
Vienna, Austria, 1140
Sponsors and Collaborators
Boehringer Ingelheim
  Study Documents (Full-Text)

Documents provided by Boehringer Ingelheim:
Statistical Analysis Plan  [PDF] March 11, 2020
Study Protocol  [PDF] March 6, 2019

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT03370770    
Other Study ID Numbers: 1200-0286
First Posted: December 12, 2017    Key Record Dates
Results First Posted: December 24, 2020
Last Update Posted: December 24, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action