check_circleStudy Completed

Carcinoma, Non-Small-Cell Lung

A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients with Stage IIIb with Effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)

Trial purpose

Evaluation of gemcitabine and cisplatin in combination with either sorafenib or placebo for the treatment of patients with advanced Non-Small Cell Lung Cancer (NSCLC)

Key Participants Requirements

Sex

Both

Age

18 Years

Trial summary

Enrollment Goal
904
Trial Dates
February 2007 - June 2011
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Asklepios Fachkliniken München GautingGauting, 82131, Germany
Completed
Thoraxklinik-Heidelberg gGmbHHeidelberg, 69126, Germany
Completed
Klinik Löwenstein gGmbHLöwenstein, 74245, Germany
Completed
Kliniken der Stadt Köln - Städt. Krankenhaus Köln-MerheimKöln, 51109, Germany
Completed
St. Vincentius-Kliniken gAGKarlsruhe, 76137, Germany
Completed
Universitätsklinikum EssenEssen, 45122, Germany
Completed
Asklepios Klinik HarburgHamburg, 21075, Germany
Completed
Krankenhaus Hofheim am TaunusHofheim, 65719, Germany
Completed
Addenbrookes HospitalCambridge, CB2 0QQ, United Kingdom
Completed
New Cross HospitalWolverhampton, WV10 0QP, United Kingdom
Completed
Centre René Gauducheau - NantesNANTES, 44805, France
Completed
Clinique Sainte Marguerite - HyèresHYERES, 83400, France
Completed
Hôpital Sainte Marguerite - MarseilleMARSEILLE, 13275, France
Completed
Krankenhaus GrosshansdorfGroßhansdorf, 22927, Germany
Completed
St. Markus-KrankenhausFrankfurt, 60431, Germany
Completed
Zentralklinik Bad Berka GmbHBad Berka, 99437, Germany
Completed
Städtisches Klinikum "St. Georg" LeipzigLeipzig, 04207, Germany
Completed
Aberdeen Royal InfirmaryAberdeen, AB25 2ZN, United Kingdom
Completed
Guy's HospitalLondon, SE1 9RT, United Kingdom
Terminated
Leicester Royal InfirmaryLeicester, LE1 5WW, United Kingdom
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Terminated
Queen Elizabeth HospitalBirmingham, B15 2TH, United Kingdom
Completed
Royal Marsden Hospital (London)London, SW3 6JJ, United Kingdom
Completed
Centre Hospitalier Lyon Sud - Pierre BénitePIERRE BENITE, 69495, France
Completed
Centre Hospitalier Universitaire - GrenobleGRENOBLE, 38043, France
Completed
Hôpital Bretonneau - ToursTOURS, 37044, France
Completed
Nouvel Hopital CIVIL-CHU StrasbourgStrasbourg, 67901, France
Completed
IRCCS Istituto Clinico HumanitasRozzano, 20089, Italy
Completed
ARNAS GaribaldiCatania, 95122, Italy
Completed
A.O.U. di BolognaBologna, 40138, Italy
Completed
IRCCS Fondazione San RaffaeleMilano, 20132, Italy
Completed
Hospital Universitario 12 de OctubreMadrid, 28041, Spain
Completed
Hospital de la Santa Creu i de Sant PauBarcelona, 08025, Spain
Completed
Hospital Arnau de Vilanova de ValenciaValencia, 46015, Spain
Terminated
Hospital Universitario Virgen del RocíoSevilla, 41013, Spain
Terminated
Complejo Hospitalario Universitario A CoruñaA Coruña, 15006, Spain
Completed
UZ Leuven GasthuisbergLEUVEN, 3000, Belgium
Completed
AZ KlinaBRASSCHAAT, 2930, Belgium
Completed
Clinique Sainte-ElisabethNAMUR, 5000, Belgium
Completed
CHU de LiègeLIEGE, 4000, Belgium
Completed
Jeroen Bosch ZiekenhuisDEN BOSCH, 5211 RW, Netherlands
Completed
Hopital Européen Georges Pompidou - ParisPARIS CEDEX 15, 75908, France
Terminated
Clinique du Mail - GrenobleGRENOBLE, 38100, France
Completed
Centre de Radiologie Oncologie Médicale - NimesNIMES CEDEX 2, 30907, France
Completed
Clinique Victor Hugo - Le MansLE MANS CEDEX 2, 72015, France
Terminated
Centre Catalan d'OncologiePERPIGNAN, 66000, France
Completed
Clinique Paulmy - BayonneBAYONNE, 64100, France
Completed
A.O. San Camillo-ForlaniniRoma, 00152, Italy
Completed
AUSL 06 Livorno - ToscanaLivorno, 57124, Italy
Completed
A.O.U. Integrata VeronaVerona, 37134, Italy
Completed
ASL Sassari - SardegnaSassari, 07100, Italy
Completed
A.O.U. CareggiFirenze, 50134, Italy
Completed
AULSS 12 Veneziana - VenetoVenezia, 30122, Italy
Completed
A.O. San Gerardo di MonzaMonza, 20052, Italy
Completed
IRCCS Centro di Riferimento Oncologico - CROAviano, 33081, Italy
Completed
Hospital General Universitario de ValenciaValencia, 46014, Spain
Completed
Consorci Sanitari de TerrassaTerrassa, 08227, Spain
Completed
Ziekenhuis Gelderse ValleiEde, 6716 RP, Netherlands
Completed
Atrium Medisch Centrum ParkstadHEERLEN, 6419 PC, Netherlands
Completed
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"Guadalajara, 44280, Mexico
Completed
Hospital Universitario "José Eleuterio González"Monterrey, 64460, Mexico
Completed
Instituto Nacional de CancerologíaMéxico, 14080, Mexico
Completed
Universitätsklinikum InnsbruckInnsbruck, 6020, Austria
Terminated
Krankenhaus HietzingWien, 1130, Austria
Terminated
SMZ Baumgartner Höhe Otto Wagner SpitalWien, 1140, Austria
Terminated
Orszagos Koranyi TBC es Pulmonologiai IntezetBudapest, 1121, Hungary
Terminated
Fovarosi Onkormanyzat Szent Janos Korhaza es Eszak-BudaiBudapest, 1125, Hungary
Completed
Sotiria General State Hospital of Chest DiseasesAthens, 11527, Greece
Terminated
Sotiria General State Hospital of Chest DiseasesAthens, 11527, Greece
Completed
Santa Casa de Misericórdia da Bahia Hospital Santa IzabelSalvador, 40050410, Brazil
Completed
Hospital LifecenterBelo Horizonte, 30110-090, Brazil
Completed
Hospital Virgen de la VictoriaMálaga, 29010, Spain
Completed
Hospital Regional Carlos HayaMálaga, 29010, Spain
Completed
Hospital de CrucesCruces/Barakaldo, 48903, Spain
Completed
Hospital Clínico Universitario de ValenciaValencia, 46010, Spain
Terminated
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Terminated
Royal Victoria HospitalMontreal, H3A 1A1, Canada
Completed
UZ AntwerpenEDEGEM, 2650, Belgium
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
Ziekenhuis St. JansdalHARDERWIJK, 3844 DG, Netherlands
Completed
St. Antonius ZiekenhuisNIEUWEGEIN, 3435 CM, Netherlands
Completed
Meir Medical CenterKfar Saba, 4428164, Israel
Completed
Chaim Sheba Medical CenterTel Hashomer, 5262000, Israel
Completed
Kaplan Medical CenterRehovot, 7610001, Israel
Completed
Barzilai Medical CenterAshkelon, 7830604, Israel
Completed
Edith Wolfson Medical CenterHolon, 58100, Israel
Terminated
Hospital Amaral CarvalhoJaú, 17210-120, Brazil
Terminated
Hospital Universitário de BrasíliaBrasília, 70840 901, Brazil
Terminated
Instituto Nacional do CancerRio de Janeiro, 20231 050, Brazil
Completed
Santo Andre Diagnostico e TerapeuticaSanto Andre, 09090-780, Brazil
Terminated
Hospital Israelita Albert EinsteinSão Paulo, 05651-901, Brazil
Terminated
Centro Goiano de OncologiaGoiânia, 74075040, Brazil
Terminated
Oncovida/Centro Médico IguatemiSalvador, 41820 021, Brazil
Terminated
Hospital das Clínicas da Faculdade de Medicina da USPSão Paulo, 05403-010, Brazil
Completed
Shanghai Chest Hospital, Shanghai Jiaotong UniversityShanghai, 200030, China
Completed
Cancer Hospital, Chinese Academy of Medical SciencesBeijing, 100021, China
Completed
Tongji Hosp. of Huazhong Univ. of Science & TechnologyWuhan, 430030, China
Completed
Shanghai Pulmonary Hospital, Tongji UniversityShanghai, 200433, China
Completed
Universitätsspital BaselBasel, 4031, Switzerland
Terminated
Hôpital Cantonal Universitaire de GenèveGenéve, 1205, Switzerland
Completed
Krankenhaus der Elisabethinen LinzLinz, 4010, Austria
Terminated
Csongrad Megyei Onkormanyzat Mellkasi Betegsegek SzakkorhazaDeszk, 6772, Hungary
Terminated
Matrai State HospitalMatrahaza, 3233, Hungary
Terminated
Fejer megyei Szent Gyorgy KorhazSzekesfehervar, 8000, Hungary
Terminated
Pest County Lung InstituteTorokbalint, 2045, Hungary
Completed
University General Hospital of HeraklionHeraklion, 711 10, Greece
Terminated
Faculdade de Medicina do ABCSanto André, 09060-870, Brazil
Completed
Hospital Sao Lucas da Pontificia Universidade Catolica do RSPorto Alegre, 90610-000, Brazil
Completed
Irmandade da Santa Casa de Misericordia - Sao PauloSão Paulo, 01221020, Brazil
Completed
Irmandade Santa Casa de Misericordia de Porto AlegrePorto Alegre, 90050 170, Brazil
Terminated
Conjunto Hospitalar de SorocabaSorocaba, 18030-510, Brazil
Terminated
Office of Dr. Agnaldo AnelliSão Paulo, 01331020, Brazil
Terminated
Nucleo de Oncologia de SalvadorSalvador, 40170-070, Brazil
Terminated
Hosp. Araujo Jorge da Associação de Combate ao CâncerGoiania, 74605-070, Brazil
Completed
Tampereen yliopistollinen sairaala, keskussairaalaTampere, FIN-33521, Finland
Completed
TYKS/Paimion SairaalaPreitilä, 21540, Finland
Completed
Sun Yat-sen University Cancer CenterGuangzhou, 510060, China
Completed
PLA 81 HospitalNanjing, 210002, China
Completed
Sir Run Run Shaw HospitalHangzhou, 310016, China
Completed
Zhejiang Cancer HospitalHangzhou, 310022, China
Completed
Inselspital BernBern, 3010, Switzerland
Completed
HUS, Meilahden sairaalaHUS, 00029, Finland
Completed
Bank of Cyprus Oncology CentreNicosia, 2006, Cyprus

Primary Outcome

  • Overall Survival (OS) in the ITT (non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient until 38 months or date of death of any cause whichever came first
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • OS in the ITT (both squamous and non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient until 38 months or date of death of any cause whichever came first
    enhanced_encryption
    Safety Issue:
    No
  • OS in the ITT (squamous) population
    date_rangeTime Frame:
    from randomization of the first patient until 38 months or date of death of any cause whichever came first
    enhanced_encryption
    Safety Issue:
    No
  • Progression-free Survival (PFS) in the ITT (non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient until 38 months or date of death or progession whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Time to progression (TTP) in the ITT (non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient until 38 months or date of death or progession whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with different Tumor Response in the ITT (non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient until 38 months or date of death or progession whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Disease Control (DC) in the ITT (non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient until 38 months or date of death or progession whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Response in the ITT (non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient until 38 months or date of death or progession whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Duration of Stable Disease (SD) in the ITT (non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient until 38 months or date of death or progession whichever came first, assessed until discontinuation every 6 weeks up to 9 months and then every 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Time to Response (TTR) in the ITT (non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient until 38 months or date of death of any cause whichever came first
    enhanced_encryption
    Safety Issue:
    No
  • Functional Assessment of Cancer Treatment-Lung (FACT-L) scores in the ITT (non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient until 38 months
    enhanced_encryption
    Safety Issue:
    No
  • Lung Cancer subscale (LCS) scores in the ITT (non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient to 38 months later or death whatever occurs first.
    enhanced_encryption
    Safety Issue:
    No
  • Time to symptomatic deterioration (TSD) in the ITT (non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient to 38 months later or death whatever occurs first
    enhanced_encryption
    Safety Issue:
    No
  • Euro quality of life - 5D (EQ-5D) index scores in the ITT (non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient until 38 months later or death whatever occurs first
    enhanced_encryption
    Safety Issue:
    No
  • EQ-5D visual analog scale (VAS) scores in the ITT (non-squamous) population
    date_rangeTime Frame:
    from randomization of the first patient until 38 months later or death whatever occurs first
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Phase III Randomized, Double-blind, Placebo Controlled Trial Comparing the Efficacy of Gemcitabine, Cisplatin and Sorafenib to Gemcitabine, Cisplatin and Placebo in First-Line Treatment of Patients with Stage IIIb with effusion and Stage IV Non-Small Cell Lung Cancer (NSCLC)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2