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Study of Cisplatin/Vinorelbine +/- Cetuximab as First-line Treatment of Advanced Non Small Cell Lung Cancer (FLEX) (FLEX)

13 juni 2014 uppdaterad av: Merck KGaA, Darmstadt, Germany

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.

The purpose of this trial is to investigate the efficacy of cetuximab in combination with chemotherapy in comparison to chemotherapy alone in patients with advanced non small cell lung cancer who did not received prior chemotherapy. Overall survival will be taken as primary measure of efficacy.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

1861

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
      • Cordoba, Argentina
        • Research Site
  • Australien
      • Adelaide, Australien
        • Research Site
      • Melbourne, Australien
        • Research Site
      • Randwick, Australien
        • Research Site
      • Sydney, Australien
        • Research Site
      • Wodonga, Australien
        • Research Site
  • Belgien
      • Bruxelles, Belgien
        • Research Site
      • Charleroi, Belgien
        • Research Site
      • Liège, Belgien
        • Research Site
  • Brasilien
      • Porto Alegre, Brasilien
        • Research Site
      • Sao Paulo, Brasilien
        • Research Site
  • Bulgarien
      • Pleven, Bulgarien
        • Research Site
      • Sofia, Bulgarien
        • Research Site
      • Stara Zagora, Bulgarien
        • Research Site
      • Veliko Tarnovo, Bulgarien
        • Research Site
  • Chile
      • Antofagasta, Chile
        • Research Site
      • Santiago de Chile, Chile
        • Research Site
  • Frankrike
      • Brest, Frankrike
        • Research Site
      • Caen, Frankrike
        • Research Site
      • Grenoble, Frankrike
        • Research Site
      • Marseille, Frankrike
        • Research Site
      • Paris, Frankrike
        • Research Site
      • Poitiers, Frankrike
        • Research Site
      • Rennes, Frankrike
        • Research Site
      • Rouen, Frankrike
        • Research Site
      • Strasbourg, Frankrike
        • Research Site
  • Hong Kong
      • Honh Kong, Hong Kong
        • Research Site
  • Irland
      • Dublin, Irland
        • Research Site
  • Italien
      • Bologna, Italien
        • Research Site
      • Carpi, Italien
        • Research Site
      • Milano, Italien
        • Research Site
      • Rome, Italien
        • Research Site
      • Rozzano-Milano, Italien
        • Research Site
      • Treviglio, Italien
        • Research Site
  • Kalkon
      • Ankara, Kalkon
        • Research Site
  • Korea, Republiken av
      • Seoul, Korea, Republiken av
        • Research Site
  • Mexiko
      • Mexico-City, Mexiko
        • Research Site
      • Monterrey, Mexiko
        • Research Site
  • Nederländerna
      • Amsterdam, Nederländerna
        • Research Site
      • Nieuwegeln, Nederländerna
        • Research Site
      • Zwolle, Nederländerna
        • Research Site
  • Polen
      • Bydgoszcz, Polen
        • Research Site
      • Olsztyn, Polen
        • Research Site
      • Otwock, Polen
        • Research Site
      • Posnan, Polen
        • Research Site
      • Warszawa, Polen
        • Research Site
      • Wroclaw, Polen
        • Research Site
  • Ryska Federationen
      • Moscow, Ryska Federationen
        • Research Site
      • St. Petersburg, Ryska Federationen
        • Research Site
  • Schweiz
      • Bern, Schweiz
        • Research Site
      • Thun, Schweiz
        • Research Site
      • Zürich, Schweiz
        • Research Site
  • Singapore
      • Singapore, Singapore
        • Research Site
  • Slovakien
      • Banska Bystrica, Slovakien
        • Research Site
      • Bratislava, Slovakien
        • Research Site
      • Nitra-Zobor, Slovakien
        • Research Site
      • Poprad, Slovakien
        • Research Site
  • Spanien
      • Barakaldo (Bilbao), Spanien
        • Research Site
      • Barcelona, Spanien
        • Research Site
      • Elche Alicante, Spanien
        • Research Site
      • Granollers, Spanien
        • Research Site
      • Madrid, Spanien
        • Research Site
      • Pamplona, Spanien
        • Research Site
      • Pontevedra, Spanien
        • Research Site
      • San Sebastian, Spanien
        • Research Site
      • Santander, Spanien
        • Research Site
      • Terrassa, Spanien
        • Research Site
      • Valencia, Spanien
        • Research Site
  • Storbritannien
      • Aberdeen, Storbritannien
        • Research Site
      • Bristol, Storbritannien
        • Research Site
      • Edinburgh, Storbritannien
        • Research Site
      • Leicester, Storbritannien
        • Research Site
      • London, Storbritannien
        • Research Site
      • Newcastle upon Tyne, Storbritannien
        • Research Site
      • Poole, Storbritannien
        • Research Site
      • Sutton, Storbritannien
        • Research Site
      • Wolverhampton, Storbritannien
        • Research Site
  • Sverige
      • Stockholm, Sverige
        • Research Site
      • Uppsala, Sverige
        • Research Site
  • Taiwan
      • Taipei, Taiwan
        • Research Site
    • Tao Yuan County
      • Taipei, Tao Yuan County, Taiwan
        • Research Site
  • Tjeckien
      • Brno, Tjeckien
        • Research Site
      • Ostrava, Tjeckien
        • Research Site
      • Pilsen, Tjeckien
        • Research Site
      • Praha, Tjeckien
        • Research Site
  • Tyskland
      • Augsburg, Tyskland
        • Research Site
      • Berlin, Tyskland
        • Research Site
      • Essen, Tyskland
        • Research Site
      • Freiburg, Tyskland
        • Research Site
      • Gauting, Tyskland
        • Research Site
      • Großhansdorf, Tyskland
        • Research Site
      • Göttingen, Tyskland
        • Research Site
      • Halle-Dölau, Tyskland
        • Research Site
      • Hamburg, Tyskland
        • Research Site
      • Heidelberg, Tyskland
        • Research Site
      • Köln, Tyskland
        • Research Site
      • Löwenstein, Tyskland
        • Research Site
      • Magdeburg, Tyskland
        • Research Site
      • Mainz, Tyskland
        • Research Site
      • München, Tyskland
        • Research Site
      • Stralsund, Tyskland
        • Research Site
      • Wuppertal, Tyskland
        • Research Site
  • Ukraina
      • Dnipropetrovsk, Ukraina
        • Research Site
      • Kharkiv, Ukraina
        • Research Site
      • Kyiv, Ukraina
        • Research Site
      • Lviv, Ukraina
        • Research Site
      • Poltava, Ukraina
        • Research Site
      • Sumy, Ukraina
        • Research Site
      • Ternopol, Ukraina
        • Research Site
      • Uzhgorod, Ukraina
        • Research Site
  • Ungern
      • Budapest, Ungern
        • Research Site
      • Nyiregyháza, Ungern
        • Research Site
      • Szombathely, Ungern
        • Research Site
      • Székesfehérvár, Ungern
        • Research Site
      • Torokbalint, Ungern
        • Research Site
      • Zalegerzeg-Pózva, Ungern
        • Research Site
  • Österrike
      • Wien, Österrike
        • Research Site

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Cetuximab plus chemotherapy
cetuximab + cisplatin + vinorelbine
Läkemedel: 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.
Aktiv komparator: Chemotherapy alone
cisplatin + vinorelbine alone
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Overall Survival Time (OS)
Tidsram: 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
Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression-free Survival Time
Tidsram: 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

Duration from randomization until radiological progression (based on modified World Health Organisation (WHO) criteria) or death due to any cause.

Only deaths within 60 days of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment.
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
Best Overall Response Rate
Tidsram: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
The best overall response rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified WHO criteria).
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Disease Control Rate
Tidsram: Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
The disease control rate is defined as the proportion of subjects having achieved confirmed Complete Response + Partial Response + Stable Disease as best overall response according to radiological assessments (based on modified WHO criteria).
Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Quality of Life (QOL) Assessment European Organisation for the Research and Treatment of Cancer (EORTC) QLQ-C30 Global Health Status
Tidsram: at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Mean global health status scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a better QoL.
at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Quality of Life Assessment (EORTC QLQ-C30) Social Functioning
Tidsram: at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
Mean social functioning scores (EORTC QLQ-C30) against time for each treatment group. Scores were derived from mutually exclusive sets of items, with scale scores ranging from 0 to 100 after a linear transformation. Higher scores indicate a higher level of functioning.
at baseline, at cycle 3, at month 6, reported between day of first patient randomised, Oct 2004, until cut-off date 18 Jul 2007
A Population Pharmacokinetic (PK) Analysis for Cetuximab in Non-Small Cell Lung Cancer (NSCLC) - Serum Cetuximab Concentrations
Tidsram: Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.
Population PK analysis was conducted using non-linear mixed effects modeling (NONMEM) software, integrating the PK data from this study and the Phase II study EMR 62 202-011.
Week 1, Day 1: baseline and end of infusion; Week 7, Day 43: within 12 h after cetuximab administration.
Safety - Number of Patients Experiencing Any Adverse Event
Tidsram: 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
Please refer to Adverse Events section for further details
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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Merck KGaA, Darmstadt, Germany

Utredare

  • Huvudutredare: Robert Pirker, Professor, Universitätsklinik für Innere Medizin I, Wien

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2004

Primärt slutförande (Faktisk)

1 juli 2007

Avslutad studie (Faktisk)

1 maj 2012

Studieregistreringsdatum

Först inskickad

7 september 2005

Först inskickad som uppfyllde QC-kriterierna

7 september 2005

Första postat (Uppskatta)

8 september 2005

Uppdateringar av studier

Senaste uppdatering publicerad (Uppskatta)

25 juni 2014

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

13 juni 2014

Senast verifierad

1 juni 2014

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • EMR 62202-046

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Icke småcellig lungcancer (NSCLC)

  • Novartis Pharmaceuticals
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    Melanom | Trippel negativ bröstcancer | Anaplastisk sköldkörtelcancer | Andra fasta tumörer | Non-small Sell Lung Cancer (NSCLC)
    Förenta staterna, Italien, Spanien, Ungern, Taiwan, Tyskland, Nederländerna, Frankrike, Norge, Polen, Thailand, Libanon, Kalkon, Kanada

Kliniska prövningar på cetuximab + cisplatin + vinorelbine

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