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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01853826




Registration number
NCT01853826
Ethics application status
Date submitted
13/05/2013
Date registered
15/05/2013
Date last updated
26/03/2024

Titles & IDs
Public title
An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
Scientific title
An Open Label Trial of Afatinib (Giotrif) in Treatment-naive (1st Line) or Chemotherapy Pre-treated Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring EGFR Mutation(s)
Secondary ID [1] 0 0
2009-017661-34
Secondary ID [2] 0 0
1200.55
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - afatinib

Experimental: afatinib - Patients will receive afatinib once daily


Treatment: Drugs: afatinib
Patients will receive afatinib once daily
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Adverse Events according to Common Terminology Criteria (CTCAE Version 3)
Timepoint [1] 0 0
up to 24 months

Eligibility
Key inclusion criteria
Inclusion criteria:

Patients with:

- locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC)

- Epidermal Growth Factor Receptor (EGFR) mutation-positive result per the institution's
testing methodology.

- Adequate organ function, defined as all of the following:

1. Absolute Neutrophil Count (ANC) > 1500/mm3. (ANC >1000/mm3 may be considered in
special circumstances such as benign cyclical neutropenia as judged by the
investigator and in discussion with the sponsor).

2. Platelet count >75,000/mm3

3. Serum creatinine < 1.5 times of the upper limit of normal

4. Total Bilirubin < 1.5 times upper limit of (institutional) normal (Patients with
Gilbert's syndrome total bilirubin must be <4 times institutional upper limit of
normal).

5. Aspartate Amino Transferase (AST) or Alanine Amino Transferase (ALT) < three
times the upper limit of (institutional) normal (ULN) (if related to liver
metastases < five times ULN).

- Eastern Cooperative Oncology Group (ECOG) score between 0 - 2

- written informed consent by patient or guardian prior to admission into the trial that
is consistent with International Conference on Harmonisation (ICH)- Good Clinical
Practice (GCP) guidelines and local law.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

Patients who or with:

- prior treatment with an EGFR tyrosine kinase inhibitor (TKI)

- anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use
of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer
permitted)

- radiotherapy within 14 days prior to drug administration, except as follows:

1. Palliative radiation to organs other than chest may be allowed up to 2 weeks
prior to drug administration, and

2. Single dose palliative treatment for symptomatic metastasis outside above
allowance to be discussed with sponsor prior to enrolling.

- previous or concomitant malignancies at other sites, except effectively treated
non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ
or effectively treated malignancy that has been in remission for more than 3 years and
is considered to be cured.

- known pre-existing interstitial lung disease

- meningeal carcinomatosis and symptomatic brain metastases (patients with asymptomatic
brain metastases, who were previously treated, are eligible provided they have had
Stable Disease (SD) for at least 4 weeks on stable doses of medication)

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/07/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/03/2024
Sample size
Target
Accrual to date
Final
481
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
The Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Sunshine Hospital - AT Albans
Recruitment hospital [3] 0 0
St John of God Murdoch - Murdoch
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
3021 - AT Albans
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Graz
Country [2] 0 0
Austria
State/province [2] 0 0
Linz
Country [3] 0 0
Austria
State/province [3] 0 0
Wels
Country [4] 0 0
Austria
State/province [4] 0 0
Wien
Country [5] 0 0
Czechia
State/province [5] 0 0
Brno
Country [6] 0 0
Czechia
State/province [6] 0 0
Hradec Kralove
Country [7] 0 0
Czechia
State/province [7] 0 0
Ostrava
Country [8] 0 0
Czechia
State/province [8] 0 0
Plzen
Country [9] 0 0
Greece
State/province [9] 0 0
Athens
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Greece
State/province [10] 0 0
N. Faliro
Country [11] 0 0
Greece
State/province [11] 0 0
Nea Kifisia
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Deszk
Country [15] 0 0
Hungary
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Farkasgyepü
Country [16] 0 0
Hungary
State/province [16] 0 0
Szekesfehervar
Country [17] 0 0
Israel
State/province [17] 0 0
Beer Sheva
Country [18] 0 0
Israel
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Kfar Saba
Country [19] 0 0
Israel
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Petah Tikva
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Israel
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Tel Hashomer
Country [21] 0 0
Israel
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Tel-Aviv
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Italy
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Alessandria
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Italy
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Ancona
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Italy
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Avellino
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Italy
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Aviano (PN)
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Italy
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Bari
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Italy
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Bergamo
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Italy
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Bologna
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Bolzano
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Italy
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Brescia
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Italy
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Firenze
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Italy
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Genova
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Italy
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Imola
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Italy
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Lecce
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Italy
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Lucca
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Italy
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Meldola (FC)
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Italy
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Milano
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Italy
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Modena
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Italy
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Monza (MI)
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Italy
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Napoli
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Italy
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Novara
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Italy
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Orbassano (TO)
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Italy
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Padova
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Italy
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Palermo
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Italy
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Parma
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Italy
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Perugia
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Italy
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Pisa
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Italy
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Ravenna
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Italy
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Rionero In Vulture (PZ)
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Italy
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Roma
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Italy
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Terni
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Torino
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Treviso
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Udine
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Verona
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Poland
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Bydgoszcz
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Gdansk
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Lodz
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Lublin
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Poznan
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Warszawa
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Portugal
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Coimbra
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Portugal
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Lisboa
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Portugal
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Porto
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Portugal
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Vila Nova de Gaia
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Omsk
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Russian Federation
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St. Petersburg
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Spain
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A Coruña
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Alicante
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Badalona
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Barakaldo (Bilbao)
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Barcelona
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Cordoba
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Granada
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L'Hospitalet de Llobregat
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La Laguna - Tenerife
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Madrid
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Majadahonda (Madrid)
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Spain
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Malaga
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Oviedo
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Spain
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Palma de Mallorca
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Spain
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Pamplona
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Spain
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Santiago de Compostela
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Sevilla
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Spain
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Valencia
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Spain
State/province [88] 0 0
Zaragoza

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the safety and tolerability of afatinib (Giotrif) in patients with locally
advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR mutation(s) and have
never been treated with an EGFR-TKI
Trial website
https://clinicaltrials.gov/ct2/show/NCT01853826
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries