Clinical trial · Observational
GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations
An Observational Study of GIOTRIF (Afatinib) for First Line Therapy in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) Harboring Epidermal Growth Factor Receptor (EGFR)-Mutations.
- 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 observational study will investigate the efficacy, safety, tolerability and symptom control of GIOTRIF (Afatinib) in daily routine first-line therapy in patients with locally advanced or metastatic NSCLC harboring EGFR-mutations. Eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with GIOTRIF in first line according to the local label, will be followed up for approximately 24 months.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Afatinib | Drug | Afatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Afatinib
- interventionNames
- Drug: Afatinib
Primary outcomes (1)
- measure
- Progression Free Survival (PFS) Rate After 12 Months
- timeFrame
- After 12 months
- description
- The rate (probability) of being progression free after 12 months. PFS is defined as the time from first administration of the trial drug until objective tumor progression or death. The rate is the Kaplan-Meier estimated percent probability.
Secondary outcomes (8)
- measure
- Objective Response Rate (ORR)
- timeFrame
- From the initial dose of study drug until end of the treatment period, up to 48 months.
- description
- Objective response rate is calculated as a percentage of participants with complete response (CR) or partial response (PR) (i.e CR+PR) as best unconfirmed response. Here CR and PR were determined by investigators by using RECIST/WHO/clinical evidence as investigators deemed appropriate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * EGFR- tyrosine kinase inhibitor (TKI) naive patients with histologically confirmed locally advanced or metastatic NSCLC with activating EGFR-mutations * Age \>= 18 years * No diagnostic or therapeutic measures beyond routine clinical practice are required * Patients for whom the treating physician has decided to initiate treatment with GIOTRIF * Written informed consent prior inclusion Exclusion criteria: * Contraindication for Afatinib according to the Summary of Product characteristics * Participation in another clinical study until 30 days after end of treatment * Prior systemic chemotherapy (Neo-/adjuvant therapy is permitted) * Previous treatment with an EGFR-tyrosine kinase inhibitor * Patients not willing or not able to fill in quality of life questionnaires * Patients with missing or impaired legal capacity * Pregnancy
References
Publications (1)
- DERIVEDBrueckl WM, Reck M, Schafer H, Neben K, Griesinger F, Rawluk J, Kruger S, Kokowski K, Ficker JH, Moller M, Schueler A, Laack E. Older patients with EGFR mutation-positive non-small cell lung cancer treated with afatinib in clinical practice: A subset analysis of the non-interventional GIDEON study. J Geriatr Oncol. 2023 Jan;14(1):101394. doi: 10.1016/j.jgo.2022.10.009. Epub 2022 Oct 30. PMID 36323612