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.
Brief Title
Afatinib Osimertinib Sequencing NIS
Categories
Completion Date
Completion Date Type
Actual
Conditions
Carcinoma, Non-Small-Cell Lung
Eligibility Criteria
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)
* 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)
Inclusion Criteria
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)
* 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)
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03370770
Org Class
Industry
Org Full Name
Boehringer Ingelheim
Org Study Id
1200-0286
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
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.
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.
Outcome Measure
Time on Treatment With Afatinib (Gi(l)Otrif®) Followed by Osimertinib
Outcome 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.
Secondary Outcomes
Outcome Description
Different types of resistance mutations identified at the time of discontinuation of osimertinib treatment were systematically reviewed and categorised.
Outcome Time Frame
Data collected from start of treatment until data entry completion; up to 96.8 months.
Outcome Measure
The Percentage of Participants With Different Types of Mutations After Categorisation
See Also Links
Url
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rasim Gucalp
Investigator Email
rgucalp@montefiore.org
Investigator Phone