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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00148798




Registration number
NCT00148798
Ethics application status
Date submitted
7/09/2005
Date registered
8/09/2005
Date last updated
25/06/2014

Titles & IDs
Public title
Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX)
Scientific title
Open, Randomized, Controlled, Multicenter Phase III Study Comparing Cisplatin/Vinorelbine Plus Cetuximab Versus Cisplatin/Vinorelbine as First-line Treatment for Patients With Epidermal Growth Factor Receptor Expressing (EGFR-expressing) Advanced NSCLC.
Secondary ID [1] 0 0
EMR 62202-046
Universal Trial Number (UTN)
Trial acronym
FLEX
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cetuximab + cisplatin + vinorelbine
Treatment: Drugs - cisplatin + vinorelbine

Experimental: Cetuximab plus chemotherapy - cetuximab + cisplatin + vinorelbine

Active comparator: Chemotherapy alone - cisplatin + vinorelbine alone


Treatment: Drugs: cetuximab + cisplatin + vinorelbine
cetuximab given as an intravenous (i.v.) infusion every week (400mg/m\^2 initial dose and 250mg/m\^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.

Treatment: Drugs: cisplatin + vinorelbine
cisplatin 80mg/m\^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m\^2 i.v. infusion on days 1 and 8 of each 3-week cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival Time (OS)
Timepoint [1] 0 0
Time from randomisation to death or last day known to be alive, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Secondary outcome [1] 0 0
Progression-free Survival Time
Timepoint [1] 0 0
Time from randomization to disease progression, death or last tumor assessment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Secondary outcome [2] 0 0
Best Overall Response Rate
Timepoint [2] 0 0
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Secondary outcome [3] 0 0
Disease Control Rate
Timepoint [3] 0 0
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Secondary outcome [4] 0 0
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
Timepoint [4] 0 0
at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Secondary outcome [5] 0 0
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
Timepoint [5] 0 0
at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Secondary outcome [6] 0 0
A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations
Timepoint [6] 0 0
Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.
Secondary outcome [7] 0 0
Safety - Number of Patients Experiencing Any Adverse Event
Timepoint [7] 0 0
time from first dose up to 30 after last dose of study treatment, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007

Eligibility
Key inclusion criteria
* Diagnosis of histologically or cytologically confirmed NSCLC, stage IIIb with documented malignant pleural effusion or stage IV
* Immunohistochemical evidence of EGFR expression on tumor tissue
* Presence of at least 1 bi-dimensionally measurable index lesion, whereby index lesions must not lie in an irradiated area
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Previous exposure to monoclonal antibodies, signal transduction inhibitors or EGFR-targeting therapy
* Previous chemotherapy for NSCLC
* Documented or symptomatic brain metastasis
* Superior vena cava syndrome contra-indicating hydration
* Previous malignancy in the last 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Parallel
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
1/10/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2012
Sample size
Target
Accrual to date
Final
1861
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Site - Adelaide
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment hospital [3] 0 0
Research Site - Randwick
Recruitment hospital [4] 0 0
Research Site - Sydney
Recruitment hospital [5] 0 0
Research Site - Wodonga
Recruitment postcode(s) [1] 0 0
- Adelaide
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Randwick
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
- Wodonga
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Cordoba
Country [3] 0 0
Austria
State/province [3] 0 0
Wien
Country [4] 0 0
Belgium
State/province [4] 0 0
Bruxelles
Country [5] 0 0
Belgium
State/province [5] 0 0
Charleroi
Country [6] 0 0
Belgium
State/province [6] 0 0
Liège
Country [7] 0 0
Brazil
State/province [7] 0 0
Porto Alegre
Country [8] 0 0
Brazil
State/province [8] 0 0
Sao Paulo
Country [9] 0 0
Bulgaria
State/province [9] 0 0
Pleven
Country [10] 0 0
Bulgaria
State/province [10] 0 0
Sofia
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Stara Zagora
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Veliko Tarnovo
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Chile
State/province [13] 0 0
Antofagasta
Country [14] 0 0
Chile
State/province [14] 0 0
Santiago de Chile
Country [15] 0 0
Czech Republic
State/province [15] 0 0
Brno
Country [16] 0 0
Czech Republic
State/province [16] 0 0
Ostrava
Country [17] 0 0
Czech Republic
State/province [17] 0 0
Pilsen
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Praha
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France
State/province [19] 0 0
Brest
Country [20] 0 0
France
State/province [20] 0 0
Caen
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France
State/province [21] 0 0
Grenoble
Country [22] 0 0
France
State/province [22] 0 0
Marseille
Country [23] 0 0
France
State/province [23] 0 0
Paris
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France
State/province [24] 0 0
Poitiers
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France
State/province [25] 0 0
Rennes
Country [26] 0 0
France
State/province [26] 0 0
Rouen
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France
State/province [27] 0 0
Strasbourg
Country [28] 0 0
Germany
State/province [28] 0 0
Augsburg
Country [29] 0 0
Germany
State/province [29] 0 0
Berlin
Country [30] 0 0
Germany
State/province [30] 0 0
Essen
Country [31] 0 0
Germany
State/province [31] 0 0
Freiburg
Country [32] 0 0
Germany
State/province [32] 0 0
Gauting
Country [33] 0 0
Germany
State/province [33] 0 0
Großhansdorf
Country [34] 0 0
Germany
State/province [34] 0 0
Göttingen
Country [35] 0 0
Germany
State/province [35] 0 0
Halle-Dölau
Country [36] 0 0
Germany
State/province [36] 0 0
Hamburg
Country [37] 0 0
Germany
State/province [37] 0 0
Heidelberg
Country [38] 0 0
Germany
State/province [38] 0 0
Köln
Country [39] 0 0
Germany
State/province [39] 0 0
Löwenstein
Country [40] 0 0
Germany
State/province [40] 0 0
Magdeburg
Country [41] 0 0
Germany
State/province [41] 0 0
Mainz
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Germany
State/province [42] 0 0
München
Country [43] 0 0
Germany
State/province [43] 0 0
Stralsund
Country [44] 0 0
Germany
State/province [44] 0 0
Wuppertal
Country [45] 0 0
Hong Kong
State/province [45] 0 0
Honh Kong
Country [46] 0 0
Hungary
State/province [46] 0 0
Budapest
Country [47] 0 0
Hungary
State/province [47] 0 0
Nyiregyháza
Country [48] 0 0
Hungary
State/province [48] 0 0
Szombathely
Country [49] 0 0
Hungary
State/province [49] 0 0
Székesfehérvár
Country [50] 0 0
Hungary
State/province [50] 0 0
Torokbalint
Country [51] 0 0
Hungary
State/province [51] 0 0
Zalegerzeg-Pózva
Country [52] 0 0
Ireland
State/province [52] 0 0
Dublin
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Italy
State/province [53] 0 0
Bologna
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Italy
State/province [54] 0 0
Carpi
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Italy
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Milano
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Italy
State/province [56] 0 0
Rome
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Italy
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Rozzano-Milano
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Italy
State/province [58] 0 0
Treviglio
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Korea, Republic of
State/province [59] 0 0
Seoul
Country [60] 0 0
Mexico
State/province [60] 0 0
Mexico-City
Country [61] 0 0
Mexico
State/province [61] 0 0
Monterrey
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Netherlands
State/province [62] 0 0
Amsterdam
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Netherlands
State/province [63] 0 0
Nieuwegeln
Country [64] 0 0
Netherlands
State/province [64] 0 0
Zwolle
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Poland
State/province [65] 0 0
Bydgoszcz
Country [66] 0 0
Poland
State/province [66] 0 0
Olsztyn
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Poland
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Otwock
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Poland
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Posnan
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Poland
State/province [69] 0 0
Warszawa
Country [70] 0 0
Poland
State/province [70] 0 0
Wroclaw
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Russian Federation
State/province [71] 0 0
Moscow
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Russian Federation
State/province [72] 0 0
St. Petersburg
Country [73] 0 0
Singapore
State/province [73] 0 0
Singapore
Country [74] 0 0
Slovakia
State/province [74] 0 0
Banska Bystrica
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Slovakia
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Bratislava
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Slovakia
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Nitra-Zobor
Country [77] 0 0
Slovakia
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Poprad
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Spain
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Barakaldo (Bilbao)
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Spain
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Barcelona
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Spain
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Elche Alicante
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Granollers
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Spain
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Madrid
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Spain
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Pamplona
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Spain
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Pontevedra
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Spain
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San Sebastian
Country [86] 0 0
Spain
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Santander
Country [87] 0 0
Spain
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Terrassa
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Spain
State/province [88] 0 0
Valencia
Country [89] 0 0
Sweden
State/province [89] 0 0
Stockholm
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Sweden
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Uppsala
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Switzerland
State/province [91] 0 0
Bern
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Switzerland
State/province [92] 0 0
Thun
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Switzerland
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Zürich
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Taiwan
State/province [94] 0 0
Tao Yuan County
Country [95] 0 0
Taiwan
State/province [95] 0 0
Taipei
Country [96] 0 0
Turkey
State/province [96] 0 0
Ankara
Country [97] 0 0
Ukraine
State/province [97] 0 0
Dnipropetrovsk
Country [98] 0 0
Ukraine
State/province [98] 0 0
Kharkiv
Country [99] 0 0
Ukraine
State/province [99] 0 0
Kyiv
Country [100] 0 0
Ukraine
State/province [100] 0 0
Lviv
Country [101] 0 0
Ukraine
State/province [101] 0 0
Poltava
Country [102] 0 0
Ukraine
State/province [102] 0 0
Sumy
Country [103] 0 0
Ukraine
State/province [103] 0 0
Ternopol
Country [104] 0 0
Ukraine
State/province [104] 0 0
Uzhgorod
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Aberdeen
Country [106] 0 0
United Kingdom
State/province [106] 0 0
Bristol
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Edinburgh
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Leicester
Country [109] 0 0
United Kingdom
State/province [109] 0 0
London
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Newcastle upon Tyne
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Poole
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Sutton
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Wolverhampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck KGaA, Darmstadt, Germany
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Pirker, Professor
Address 0 0
Universitätsklinik für Innere Medizin I, Wien
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Pirker R, Pereira JR, Szczesna A, von Pawel J, Krz... [More Details]

Results are available at https://clinicaltrials.gov/study/NCT00148798