Trial Description Organizational Data

DRKS-ID: DRKS00007483
Date of Registration in DRKS: 2015/01/21
Date of Registration in Partner Registry or other Primary Registry: 2014/01/27
PLEASE NOTE: This study has been imported from ClinicalTrials.gov without additional data
checks.
Trial Description
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.
Trial Acronym
[---]*
URL of the trial
[---]*
Brief Summary in Lay Language
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.
Brief Summary in Scientific Language
Study Design:
Organizational Data
DRKS-ID: DRKS00007483
Date of Registration in DRKS: 2015/01/21
Date of Registration in Partner Registry or other Primary Registry: 2014/01/27
Investigator Sponsored/Initiated Trial (IST/IIT): no
Ethics Approval/Approval of the Ethics Committee: [---]*
(leading) Ethics Committee Nr.: [---]*
Page 1 of 6
DRKS-ID: DRKS00007483
Date of Registration in DRKS: 2015/01/21
Date of Registration in Partner Registry or other Primary Registry: 2014/01/27
Secondary IDs
Primary Registry-ID: NCT02047903 (ClinicalTrials.gov)
Sponsor-ID: 1200.205 (Boehringer Ingelheim)
Health condition or Problem studied
Free text: Carcinoma, Non-Small-Cell Lung
ICD10: C34 - Malignant neoplasm of bronchus and lung
Interventions/Observational Groups
Characteristics
Study Type: Non-interventional
Study Type Non-Interventional: Observational study
Allocation: [---]*
Blinding: [---]*
Who is blinded: [---]*
Control: [---]*
Purpose: [---]*
Assignment: [---]*
Phase: N/A
Off-label use (Zulassungsüberschreitende Anwendung eines Arzneimittels): [---]*
Primary Outcome
- Percentage of patients without tumor progression at 12 months (progressionfree survival rate at 1 year, %); time frame: up 48 month
Secondary Outcome
- Objective response rate (complete response, CR + partial response, PR, %); time
frame: up 48 month
- ,Percentage of patients with disease control (CR + PR + stable disease, SD, %);
time frame: up 48 month
- Progression free survival (PFS, month); time frame: up 48 month
- Safety: Incidence of adverse events (SAEs and AEs); time frame: up 48 month
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DRKS-ID: DRKS00007483
Date of Registration in DRKS: 2015/01/21
Date of Registration in Partner Registry or other Primary Registry: 2014/01/27
- Tolerability and side-effect profile: incidence and grade of diarrhea, rash/acne,
stomatitis and paronychia; time frame: up 48 month
- Treatment duration and modifications (dose modifications, treatment
discontinuations and interruptions); time frame: up 48 month
- Symptom control (cough, dyspnea and pain) according to EORTC-Questionnaires
QLQ C30/ LC13; time frame: up 48 month
Countries of recruitment
DE Germany
Locations of Recruitment
Boehringer Ingelheim Investigational Site 1, Berlin
Boehringer Ingelheim Investigational Site 10, Gerlingen
Boehringer Ingelheim Investigational Site 11, München
Boehringer Ingelheim Investigational Site 12, Rosenheim
Boehringer Ingelheim Investigational Site 13, Düsseldorf
Boehringer Ingelheim Investigational Site 14, Frankfurt am Main
Boehringer Ingelheim Investigational Site 15, Tübingen
Boehringer Ingelheim Investigational Site 16, Nürnberg
Boehringer Ingelheim Investigational Site 17, Schwerin
Boehringer Ingelheim Investigational Site 18, Baden-Baden
Boehringer Ingelheim Investigational Site 19, Esslingen
Boehringer Ingelheim Investigational Site 2, Zittau
Boehringer Ingelheim Investigational Site 20, Koblenz
Boehringer Ingelheim Investigational Site 21, Sonneberg
Boehringer Ingelheim Investigational Site 22, Berlin
Boehringer Ingelheim Investigational Site 23, Wilhelmshaven
Boehringer Ingelheim Investigational Site 24, Borken
Boehringer Ingelheim Investigational Site 25, Bonn
Boehringer Ingelheim Investigational Site 26, Gera
Boehringer Ingelheim Investigational Site 27, Erlangen
Boehringer Ingelheim Investigational Site 28, Halle
Boehringer Ingelheim Investigational Site 29, Aachen
Boehringer Ingelheim Investigational Site 3, Hannover
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DRKS-ID: DRKS00007483
Date of Registration in DRKS: 2015/01/21
Date of Registration in Partner Registry or other Primary Registry: 2014/01/27
Boehringer Ingelheim Investigational Site 30, Mutlangen
Boehringer Ingelheim Investigational Site 31, Bochum
Boehringer Ingelheim Investigational Site 32, Hamburg
Boehringer Ingelheim Investigational Site 33, Hamburg
Boehringer Ingelheim Investigational Site 34, Bottrop
Boehringer Ingelheim Investigational Site 35, Leipzig
Boehringer Ingelheim Investigational Site 36, Paderborn
Boehringer Ingelheim Investigational Site 37, Treuenbrietzen
Boehringer Ingelheim Investigational Site 38, Berlin
Boehringer Ingelheim Investigational Site 39, Völklingen
Boehringer Ingelheim Investigational Site 4, Fulda
Boehringer Ingelheim Investigational Site 40, Moers
Boehringer Ingelheim Investigational Site 41, Mannheim
Boehringer Ingelheim Investigational Site 42, Krefeld
Boehringer Ingelheim Investigational Site 43, Lünen
Boehringer Ingelheim Investigational Site 44, Rheine
Boehringer Ingelheim Investigational Site 45, Augsburg
Boehringer Ingelheim Investigational Site 5, Lostau
Boehringer Ingelheim Investigational Site 6, Wolfsburg
Boehringer Ingelheim Investigational Site 7, Großhansdorf
Boehringer Ingelheim Investigational Site 8, Mainz
Boehringer Ingelheim Investigational Site 9, Dresden
Recruitment
Planned/Actual: [---]*
(Anticipated or Actual) Date of First Enrollment: 2014/03/31
Target Sample Size: 150
Monocenter/Multicenter trial: Multicenter trial
National/International: National
Inclusion Criteria
Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: no maximum age
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DRKS-ID: DRKS00007483
Date of Registration in DRKS: 2015/01/21
Date of Registration in Partner Registry or other Primary Registry: 2014/01/27
Additional Inclusion 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
- Patients for whom the treating physician has decided to initiate treatment
with
GIOTRIF
- Written informed consent prior inclusion
Exclusion criteria
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 if at
least 12 months
has elapsed prior to disease progression)
- 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
Addresses
Primary Sponsor
Boehringer Ingelheim
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Contact for Scientific Queries
Boehringer Ingelheim
Boehringer Ingelheim
Page 5 of 6
DRKS-ID: DRKS00007483
Date of Registration in DRKS: 2015/01/21
Date of Registration in Partner Registry or other Primary Registry: 2014/01/27
Contact for Scientific Queries
Boehringer Ingelheim
Boehringer Ingelheim
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Contact for Public Queries
Boehringer Ingelheim Call Center
Telephone: 1-800-243-0127
Fax: [---]*
E-mail: clintriage.rdg at boehringer-ingelheim.com
URL: [---]*
Sources of Monetary or Material Support
[---]*
Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
Telephone: [---]*
Fax: [---]*
E-mail: [---]*
URL: [---]*
Status
Recruitment Status: Recruiting ongoing
Study Closing (LPLV): [---]*
Trial Publications, Results and other documents
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from
ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs.
- Translation on version: 258
- Last processed date by ClinicalTrials.gov: 2014/11/11
* This entry means the parameter is not applicable or has not been set.