N/A
N=161
GIOTRIF in First Line Therapy of Advanced NSCLC With EGFR-mutations
Carcinoma, Non-Small-Cell Lung
Bottom Line
View on ClinicalTrials.gov: NCT02047903 ↗Enrolled (actual)
161
Serious AEs
42.8%
Results posted
Jan 2020
Primary outcome: Primary: Progression Free Survival (PFS) Rate After 12 Months — 50.24 Percent probability of PFS
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Afatinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival (PFS) Rate After 12 Months |
50.24 | — |
| SECONDARY Objective Response Rate (ORR) |
74.58 | — |
| SECONDARY Disease Control Rate (DCR) |
91.53 | — |
| SECONDARY Progression Free Survival (PFS) |
12.17 | — |
| SECONDARY Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
96.05; 42.76 | — |
| SECONDARY Toxicity and Side-effect Profile: Incidence of Diarrhea, Skin Reactions, Stomatitis and Paronychia |
82.89; 18.42; 25.66; 37.50; 1.32; 16.45 | — |
| SECONDARY Treatment Duration |
324.5 | — |
| SECONDARY Symptom Control - Time to Worsening (Cough, Dyspnea and Pain) |
33.85; 22.17; 18.26 | — |
| SECONDARY Percentage of Participants With Treatment Modification |
59.87; 17.11; 61.84 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02047903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.