Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Osimertinib

Mitogens

Afatinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

(Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)

on T790M resistance mutation was developed

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.

Afatinib Osimertinib Sequencing NIS

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

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.

Different types of resistance mutations identified at the time of discontinuation of osimertinib treatment were systematically reviewed and categorised.

Boehringer Ingelheim

Participants in the Full Analysis Set (FAS), who were included in the extension period.

Patients with EGFR mutation-positive NSCLC with acquired T790M mutation at least 10 months prior to data entry, and who were treated with afatinib (Gi\[l\]otrif®) (50mg or 40mg or 30mg or 20mg tablet once daily as indicated in the approved labels of afatinib (Gi\[l\]otrif®)) in the first-line line treatment followed by second-line osimertinib treatment (80 milligram (mg) or 40 mg tablets once daily as indicated in the approved labels of osimertinib).

Patients With EGFR Mutation-positive NSCLC

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Full Analysis Set (FAS): FAS included all patients who were enrolled into the study, met all inclusion criteria and did not meet any exclusion criteria and provided a written and signed informed consent (if a written informed consent was required for this NIS by local regulation and legal requirement).

This study has no comparator group limiting the interpretability of the results as they cannot be put into perspective.

Boehringer Ingelheim, Call Centre

First analysis

Extension analysis

Full Analysis Set (FAS): All patients who were enrolled into the study, met all inclusion criteria and did not meet any exclusion criteria and provided a written and signed informed consent. 1 Patient was excluded from extension analysis due to conflicting data on the discontinuation date of osimertinib treatment.

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

T790M positive

Loss of T790M

T790M positive, loss of sensitizing mutation

Patients in the Full Analysis Set (FAS), who discontinued treatment and with positive test results (either EGFR sensitizing Mutation and/or T790M) available.

Spots Global Cancer Trial Database for Afatinib Osimertinib Sequencing NIS

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial