Clinical trial NCT02047903: GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-01-28
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NSCLC-EGFR mutation positive

Brief summary: 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.

Detailed description: Study Design:

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

Primary outcomes:
measure: Progression Free Survival (PFS) Rate After 12 Months
timeFrame: After 12 months
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From the initial dose of study drug until end of the treatment period, up to 48 months.
measure: Disease Control Rate (DCR)
timeFrame: From the initial dose of study drug until end of the treatment period, up to 48 months.
measure: Progression Free Survival (PFS)
timeFrame: From first administration of the trial drug until objective tumour progression or death, up to 48 months.
measure: Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
measure: Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia
timeFrame: From first administration of the trial drug until 30 days end after permanent discontinuation of therapy or end of study, up to 48 months.
measure: Treatment Duration
timeFrame: From the initial dose of study drug until end of the treatment period, up to 48 months.
measure: Symptom Control - Time to Worsening (Cough, Dyspnea and Pain)
timeFrame: Up to 48 months
measure: Percentage of Participants With Treatment Modification
timeFrame: From the initial dose of study drug until end of the treatment period, up to 48 months.
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: