Afatinib Osimertinib Sequencing NIS

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370770
• Other study ID #: 1200-0286
• Status: Completed
• Start date: December 28, 2017
• Est. completion date: November 28, 2019

Study information

• Verified date: December 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: November 28, 2019
• Est. primary completion date: November 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

Drug:
• Afatinib
GILOTRIF, GIOTRIF, XOVOLTIB
• Osimertinib
on T790M resistance mutation was developed

Locations

Country	Name	City	State
Austria	Otto-Wagner Hospital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time on Treatment With Afatinib (Gi(l)Otrif®) Followed by Osimertinib	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.	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.
Secondary	The Percentage of Participants With Different Types of Mutations After Categorisation	Different types of resistance mutations identified at the time of discontinuation of osimertinib treatment were systematically reviewed and categorised.	Data collected from start of treatment until data entry completion; up to 96.8 months.

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