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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with EGFR mutation-positive NSCLC | (Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afatinib | Drug | GILOTRIF, GIOTRIF, XOVOLTIB |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otto-Wagner Hospital | Vienna | 1140 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32854536 | Derived | Hochmair MJ, Morabito A, Hao D, Yang CT, Soo RA, Yang JC, Gucalp R, Halmos B, Marten A, Cufer T. Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: final analysis of the GioTag study. Future Oncol. 2020 Dec;16(34):2799-2808. doi: 10.2217/fon-2020-0740. Epub 2020 Aug 28. | |
| 32757853 |
| Label | URL |
|---|---|
| Related Info | View source |
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All patients were screened for eligibility to participate in the trial. Only patients that met all the inclusion and none of the exclusion criteria were included in the trial.
Non-interventional, multi-centre cohort study based on existing data from medical records of patients with epidermal growth factor receptor (EGFR) mutation-positive advanced non-small cell lung cancer (NSCLC) treated with afatinib (Gi[l]otrif®) as first-line treatment followed by osimertinib in case the T790M resistance mutation was developed. The study included an extension analysis using additional collected data of the enrolled patients.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With EGFR Mutation-positive NSCLC | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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).
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With EGFR Mutation-positive NSCLC | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Median | 90% Confidence Interval | Months | 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. |
Adverse event information was not applicable for this study, as data were collected retrospectively. The approach was changed for the extension period: Adverse Events were collected from start of data collection once informed consent was signed onwards until the end of data collection, up to 18 months.
Participants in the Full Analysis Set (FAS), who were included in the extension period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With EGFR Mutation-positive NSCLC | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Disease progression | General disorders | MedDRA 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
This study has no comparator group limiting the interpretability of the results as they cannot be put into perspective.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Centre | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 11, 2020 | Dec 23, 2020 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Mar 6, 2019 | Dec 23, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D000077716 | Afatinib |
| C000596361 | osimertinib |
| ID | Term |
|---|---|
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| Osimertinib |
| Drug |
on T790M resistance mutation was developed |
|
| Feinberg B, Halmos B, Gucalp R, Tang W, Moehring B, Hochmair MJ. Making the case for EGFR TKI sequencing in EGFR mutation-positive NSCLC: a GioTag study US patient analysis. Future Oncol. 2020 Aug;16(22):1585-1595. doi: 10.2217/fon-2020-0188. Epub 2020 Aug 6. |
| 31863283 | Derived | Yamamoto N, Mera T, Marten A, Hochmair MJ. Observational Study of Sequential Afatinib and Osimertinib in EGFR Mutation-Positive NSCLC: Patients Treated with a 40-mg Starting Dose of Afatinib. Adv Ther. 2020 Feb;37(2):759-769. doi: 10.1007/s12325-019-01187-y. Epub 2019 Dec 20. |
| 31370698 | Derived | Hochmair MJ, Morabito A, Hao D, Yang CT, Soo RA, Yang JC, Gucalp R, Halmos B, Wang L, Marten A, Cufer T. Sequential afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: updated analysis of the observational GioTag study. Future Oncol. 2019 Sep;15(25):2905-2914. doi: 10.2217/fon-2019-0346. Epub 2019 Aug 2. |
| 30336693 | Derived | Hochmair MJ, Morabito A, Hao D, Yang CT, Soo RA, Yang JC, Gucalp R, Halmos B, Wang L, Golembesky A, Marten A, Cufer T. Sequential treatment with afatinib and osimertinib in patients with EGFR mutation-positive non-small-cell lung cancer: an observational study. Future Oncol. 2018 Nov;14(27):2861-2874. doi: 10.2217/fon-2018-0711. Epub 2018 Oct 19. |
| Death |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | Patients With EGFR Mutation-positive NSCLC | 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). |
|
|
| 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. | Patients in the Full Analysis Set (FAS), who discontinued treatment and with positive test results (either EGFR sensitizing Mutation and/or T790M) available. | Posted | Number | Percentage of participants (%) | Data collected from start of treatment until data entry completion; up to 96.8 months. |
|
|
|
| 31 |
| 203 |
| 32 |
| 203 |
| 62 |
| 203 |
| Death | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sepsis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 20.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Paronychia | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| Title | Measurements |
|---|---|
|