Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
204 participants
OBSERVATIONAL
2017-12-28
2019-11-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
patients with EGFR mutation-positive NSCLC
(Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)
Afatinib
GILOTRIF, GIOTRIF, XOVOLTIB
Osimertinib
on T790M resistance mutation was developed
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Afatinib
GILOTRIF, GIOTRIF, XOVOLTIB
Osimertinib
on T790M resistance mutation was developed
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 with active brain metastases at start of treatment (either afatinib/Gi(l)otrif® or osimertinib)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Boehringer Ingelheim
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Otto-Wagner Hospital
Vienna, , Austria
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1200-0286
Identifier Type: -
Identifier Source: org_study_id