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
|Condition or disease||Intervention/treatment|
|Carcinoma, Non-Small-Cell Lung||Drug: Afatinib Drug: Osimertinib|
|Study Type :||Observational|
|Actual Enrollment :||204 participants|
|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|
patients with EGFR mutation-positive NSCLC
(Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)
GILOTRIF, GIOTRIF, XOVOLTIB
on T790M resistance mutation was developed
- 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.
- 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.
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
|Vienna, Austria, 1140|