GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

161 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-05

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Study Design:

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Afatinib

Intervention Type DRUG

50, 40, 30 or 20 mg

Interventions

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Afatinib

50, 40, 30 or 20 mg

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No