Afatinib Osimertinib Sequencing NIS

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: Afatinib; Drug: Osimertinib

• Registration Number: NCT03370770
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-07
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-12
• Study Start: 2017-12-28
• Primary Completion: 2019-11-28
• Study Completion: 2019-11-28
• Results First Submitted: 2020-11-24
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-23
• Last Update Submitted: 2020-12-23
• Results First Posted: 2020-12-24
• Last Update Posted: 2020-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 204

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with EGFR mutation-positive NSCLC	Osimertinib	(Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)
patients with EGFR mutation-positive NSCLC	Afatinib	(Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)

Primary Outcome Measures

Name	Time	Method
Time on Treatment With Afatinib (Gi(l)Otrif®) Followed by Osimertinib	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

Name	Time	Method
The Percentage of Participants With Different Types of Mutations After Categorisation	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.

Trial Locations

Locations (1)

Otto-Wagner Hospital; 🇦🇹 Vienna, Austria