Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT02047903
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02047903
Study Brief:
Protocol Section:
NCT02047903