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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01853826
Ethics application status
Date submitted
13/05/2013
Date registered
15/05/2013

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
NA
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
Country [10] 0 0
Greece
State/province [10] 0 0
N. Faliro
Country [11] 0 0
Greece
State/province [11] 0 0
Nea Kifisia
Country [12] 0 0
Greece
State/province [12] 0 0
Thessaloniki
Country [13] 0 0
Hungary
State/province [13] 0 0
Budapest
Country [14] 0 0
Hungary
State/province [14] 0 0
Deszk
Country [15] 0 0
Hungary
State/province [15] 0 0
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
State/province [18] 0 0
Kfar Saba
Country [19] 0 0
Israel
State/province [19] 0 0
Petah Tikva
Country [20] 0 0
Israel
State/province [20] 0 0
Tel Hashomer
Country [21] 0 0
Israel
State/province [21] 0 0
Tel-Aviv
Country [22] 0 0
Italy
State/province [22] 0 0
Alessandria
Country [23] 0 0
Italy
State/province [23] 0 0
Ancona
Country [24] 0 0
Italy
State/province [24] 0 0
Avellino
Country [25] 0 0
Italy
State/province [25] 0 0
Aviano (PN)
Country [26] 0 0
Italy
State/province [26] 0 0
Bari
Country [27] 0 0
Italy
State/province [27] 0 0
Bergamo
Country [28] 0 0
Italy
State/province [28] 0 0
Bologna
Country [29] 0 0
Italy
State/province [29] 0 0
Bolzano
Country [30] 0 0
Italy
State/province [30] 0 0
Brescia
Country [31] 0 0
Italy
State/province [31] 0 0
Firenze
Country [32] 0 0
Italy
State/province [32] 0 0
Genova
Country [33] 0 0
Italy
State/province [33] 0 0
Imola
Country [34] 0 0
Italy
State/province [34] 0 0
Lecce
Country [35] 0 0
Italy
State/province [35] 0 0
Lucca
Country [36] 0 0
Italy
State/province [36] 0 0
Meldola (FC)
Country [37] 0 0
Italy
State/province [37] 0 0
Milano
Country [38] 0 0
Italy
State/province [38] 0 0
Modena
Country [39] 0 0
Italy
State/province [39] 0 0
Monza (MI)
Country [40] 0 0
Italy
State/province [40] 0 0
Napoli
Country [41] 0 0
Italy
State/province [41] 0 0
Novara
Country [42] 0 0
Italy
State/province [42] 0 0
Orbassano (TO)
Country [43] 0 0
Italy
State/province [43] 0 0
Padova
Country [44] 0 0
Italy
State/province [44] 0 0
Palermo
Country [45] 0 0
Italy
State/province [45] 0 0
Parma
Country [46] 0 0
Italy
State/province [46] 0 0
Perugia
Country [47] 0 0
Italy
State/province [47] 0 0
Pisa
Country [48] 0 0
Italy
State/province [48] 0 0
Ravenna
Country [49] 0 0
Italy
State/province [49] 0 0
Rionero In Vulture (PZ)
Country [50] 0 0
Italy
State/province [50] 0 0
Roma
Country [51] 0 0
Italy
State/province [51] 0 0
Terni
Country [52] 0 0
Italy
State/province [52] 0 0
Torino
Country [53] 0 0
Italy
State/province [53] 0 0
Treviso
Country [54] 0 0
Italy
State/province [54] 0 0
Udine
Country [55] 0 0
Italy
State/province [55] 0 0
Verona
Country [56] 0 0
Poland
State/province [56] 0 0
Bydgoszcz
Country [57] 0 0
Poland
State/province [57] 0 0
Gdansk
Country [58] 0 0
Poland
State/province [58] 0 0
Lodz
Country [59] 0 0
Poland
State/province [59] 0 0
Lublin
Country [60] 0 0
Poland
State/province [60] 0 0
Poznan
Country [61] 0 0
Poland
State/province [61] 0 0
Warszawa
Country [62] 0 0
Portugal
State/province [62] 0 0
Coimbra
Country [63] 0 0
Portugal
State/province [63] 0 0
Lisboa
Country [64] 0 0
Portugal
State/province [64] 0 0
Porto
Country [65] 0 0
Portugal
State/province [65] 0 0
Vila Nova de Gaia
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Kazan
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Moscow
Country [68] 0 0
Russian Federation
State/province [68] 0 0
Omsk
Country [69] 0 0
Russian Federation
State/province [69] 0 0
St. Petersburg
Country [70] 0 0
Spain
State/province [70] 0 0
A Coruña
Country [71] 0 0
Spain
State/province [71] 0 0
Alicante
Country [72] 0 0
Spain
State/province [72] 0 0
Badalona
Country [73] 0 0
Spain
State/province [73] 0 0
Barakaldo (Bilbao)
Country [74] 0 0
Spain
State/province [74] 0 0
Barcelona
Country [75] 0 0
Spain
State/province [75] 0 0
Cordoba
Country [76] 0 0
Spain
State/province [76] 0 0
Granada
Country [77] 0 0
Spain
State/province [77] 0 0
L'Hospitalet de Llobregat
Country [78] 0 0
Spain
State/province [78] 0 0
La Laguna - Tenerife
Country [79] 0 0
Spain
State/province [79] 0 0
Madrid
Country [80] 0 0
Spain
State/province [80] 0 0
Majadahonda (Madrid)
Country [81] 0 0
Spain
State/province [81] 0 0
Malaga
Country [82] 0 0
Spain
State/province [82] 0 0
Oviedo
Country [83] 0 0
Spain
State/province [83] 0 0
Palma de Mallorca
Country [84] 0 0
Spain
State/province [84] 0 0
Pamplona
Country [85] 0 0
Spain
State/province [85] 0 0
Santiago de Compostela
Country [86] 0 0
Spain
State/province [86] 0 0
Sevilla
Country [87] 0 0
Spain
State/province [87] 0 0
Valencia
Country [88] 0 0
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
When will data be available (start and end dates)?
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
Available to whom?
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.mystudywindow.com/msw/datasharing


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01853826