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OpenTrials
Completed

NCT Number: NCT03370770

Afatinib Osimertinib Sequencing NIS

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.

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Key information

Conditions

Carcinoma, Non-Small-Cell Lung Bronchial Neoplasms Carcinoma, Bronchogenic Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Otto-Wagner Hospital

Vienna, 1140, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

afatinib

Drug

GILOTRIF, GIOTRIF, XOVOLTIB

Osimertinib

Drug

on T790M resistance mutation was developed

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 12, 2017
Registry last updated
Dec 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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