Clinical trial · Observational
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
NCT03370770CI-TRIAL-00049131completedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Non-Small-Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afatinib | Drug | Afatinib | ALIAS |
| Osimertinib | Drug | Osimertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- patients with EGFR mutation-positive NSCLC
- description
- (Non-Small Cell Lung Cancer) (Epidermal Growth Factor Receptor)
- interventionNames
- Drug: Afatinib
- Drug: Osimertinib
Primary outcomes (1)
- measure
- Time on Treatment With Afatinib (Gi(l)Otrif®) Followed by Osimertinib
- timeFrame
- 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.
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (5)
- DERIVEDHochmair 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. PMID 32854536
- DERIVEDFeinberg 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. PMID 32757853
- DERIVEDYamamoto 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. PMID 31863283
- DERIVEDHochmair 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. PMID 31370698
- DERIVEDHochmair 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. PMID 30336693