check_circleStudy Completed

Carcinoma, Non-Small-Cell Lung

A 3rd/4th line placebo-controlled trial of sorafenib in patients with predominantly non squamous Non-Small Cell Lung Cancer (NSCLC).

Trial purpose

The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone.

Key Participants Requirements

Sex

Both

Age

18 Years

  • - Ability to understand and willingness to sign a written Informed Consent
    - Advanced relapsed or refractory predominantly non squamous NSCLC. The diagnosis must have been confirmed cyto-/ histologically
    - Patients must have measurable or non-measurable disease
    - At least two but not more than three prior standard treatment regimens for NSCLC
    - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
    - Male or female subjects >/= 18 years of age (>/=20 for Japan) at the time of Informed Consent
    - Life expectancy of at least 12 weeks
    - Ability to swallow oral medication
    - Both men and women using adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial
    - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of the study drug:
     -- Haemoglobin > 9.0 g/dl
     -- Absolute neutrophil count (ANC) >1,500/mm3
     -- Platelet count >/= 100,000/µl
     -- Total bilirubin  -- Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (  -- Alkaline phosphatase < 4 x upper limit of normal (  -- Prothrombin Time (PT)-International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) < 1.5 x upper limit of normal
     -- Serum creatinine < 1.5 x upper limit of normal
     -- Calculated creatinine clearance of >/= 50 mL/min

  • - NSCLC patients with predominantly squamous cell carcinoma histology
    Excluded medical conditions:
    - History of cardiac disease: Congestive heart failure, Active coronary artery disease (CAD), Cardiac arrhythmias (>Grade 2 NCI-CTCAE [National Cancer Institute-Common Terminology Criteria for Adverse Events] vers. 3.0)
    - Uncontrolled hypertension despite two anti-hypertensive medications
    - History of Human immunodeficiency virus (HIV) infection or chronic hepatitis B
    or C
    - History of organ allograft
    - Active clinically serious infections (> grade 2 NCI-CTCAE vers. 3.0)
    - Patients with seizure disorder requiring medication
    - Patients with evidence or history of bleeding diathesis or coagulopathy
    - Patients undergoing renal dialysis
    - Pulmonary hemorrhage/ bleeding event >/= CTCAE grade 2 within four weeks prior to the first dose of the study drug
    - Any other hemorrhage/ bleeding event >/= CTCAE grade 3 within four weeks prior to the first dose of the study drug
    - Thrombotic or embolic venous or arterial events such as cerebrovascular accident
    - Pregnant or breast-feeding women.
    - Any condition which could affect the absorption or pharmacokinetics of the study drug
    - Prior treatment with other Vascular Endothelial Growth Factor (VEGF) (R) inhibitors, including compounds that impact vascularity (i.e. sunitinib, thalidomide, vandetanib, vascular disrupting agents [VDA], VEGF-trap and other experimental agents of this class). Only bevacizumab (Avastin) is permitted.

Trial summary

Enrollment Goal
703
Trial Dates
April 2009 - April 2013
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Krankenhaus GrosshansdorfGroßhansdorf, 22927, Germany
Completed
Asklepios Fachkliniken München GautingGauting, 82131, Germany
Terminated
Asklepios Klinik HarburgHamburg, 21075, Germany
Completed
St. Vincentius-Kliniken gAGKarlsruhe, 76137, Germany
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Completed
Royal Marsden Hospital (London)London, SW3 6JJ, United Kingdom
Completed
Aberdeen Royal InfirmaryAberdeen, AB25 2ZN, United Kingdom
Completed
Addenbrookes HospitalCambridge, CB2 0QQ, United Kingdom
Completed
Southmead HospitalBristol, BS10 5NB, United Kingdom
Completed
Highlands Oncology GroupFayetteville, 72703, United States
Completed
Centre Georges Francois Leclerc DijonDIJON, 21000, France
Completed
Hôpital de la Croix RousseLYON CEDEX, 69317, France
Completed
Hôpital Bretonneau - ToursTOURS, 37044, France
Completed
Kliniken der Stadt Köln - Städt. Krankenhaus Köln-MerheimKöln, 51109, Germany
Completed
Thoraxklinik-Heidelberg gGmbHHeidelberg, 69126, Germany
Completed
St James' University HospitalLeeds, LS9 7TF, United Kingdom
Completed
Royal Free HospitalLondon, NW3 2QG, United Kingdom
Completed
Christie HospitalGreater Manchester, M20 4BX, United Kingdom
Completed
Stanford Hospital & ClinicsStanford, 94305, United States
Completed
Centre René Gauducheau - NantesSAINT HERBLAIN, 44805, France
Completed
Specjalistyczny Szpital im. prof. Alfreda SokolowskiegoSzczecin, 70-891, Poland
Terminated
Szpital Miejski sw. AleksandraKielce, 25-316, Poland
Completed
Kinki University HospitalOsakasayama, 589-8511, Japan
Completed
Kinki-Chuo Chest Medical CenterSakai, 591-8555, Japan
Completed
National Cancer Center Hospital EastKashiwa, 277-8577, Japan
Completed
A.O. San Camillo-ForlaniniRoma, 00151, Italy
Completed
A.O.U. di PerugiaPerugia, 06156, Italy
Completed
A.O. San Gerardo di MonzaMonza, 20052, Italy
Completed
Centre Oscar LambretLille, 59020, France
Completed
Center Hospitalier Michallon - GrenobleLA TRONCHE, 38700, France
Completed
Centre François Baclesse - CLCC - CaenCAEN, 14073, France
Completed
Centrum Onkologii Instytut im. M. Sklodowskiej-CurieKrakow, 31-115, Poland
Completed
Instytut Gruzlicy i Chorob PlucWarszawa, 01-138, Poland
Completed
NZOZ MRUKMED 2 Sp. p., Przychodnia SpecjalistycznaRzeszow, 35-021, Poland
Completed
Samodzielny Publiczny Zespól Gruzlicy i Chorób PlucOlsztyn, 10-357, Poland
Completed
Teikyo University HospitalItabashi-ku, 173-8606, Japan
Completed
The Cancer Institute Hospital of JFCRKoto-ku, 135-8550, Japan
Completed
Hyogo Cancer CenterAkashi, 673-8558, Japan
Completed
National Kyushu Cancer CenterFukuoka, 811-1395, Japan
Completed
Aichi Cancer Center HospitalNagoya, 464-8681, Japan
Completed
IRCCS Istituto Clinico HumanitasRozzano, 20089, Italy
Completed
A.O.U. di ParmaParma, 43100, Italy
Completed
AUSL 06 Livorno - ToscanaLivorno, 57124, Italy
Completed
A.O.U. San Luigi GonzagaOrbassano, 10043, Italy
Completed
A.O. San Giuseppe MoscatiAvellino, 83100, Italy
Completed
Hospital Regional Carlos HayaMálaga, 29010, Spain
Completed
Complejo Hospitalario de ZamoraZamora, 49021, Spain
Completed
Hospital de CrucesCruces/Barakaldo, 48903, Spain
Completed
Hospital de la Santa Creu i de Sant PauBarcelona, 08025, Spain
Completed
Hospital Universitario Arnau de Vilanova de LleidaLleida, 25198, Spain
Completed
Hopsital Lucus AgustíLugo, 27003, Spain
Completed
Isala Klinieken, Locatie SophiaZWOLLE, 8025 AB, Netherlands
Completed
Skånes UniversitetssjukhusLund, 221 85, Sweden
Completed
Karolinska Universitetssjukhuset i SolnaStockholm, 171 76, Sweden
Completed
Falu LasarettFalun, 791 82, Sweden
Completed
Langehoven Drive Oncology CentrePort Elizabeth, 6045, South Africa
Completed
Dr Pirjol, Szpak 7 MoodleyDurban, 4126, South Africa
Completed
Meir Medical CenterKfar Saba, 4428164, Israel
Completed
Assaf Harofeh Medical CenterZrifin, 6093000, Israel
Completed
Shaare Zedek Medical CenterJerusalem, 9372212, Israel
Completed
IRCCS Ist Nazionale Tumori GEGenova, 16132, Italy
Completed
Hospital Universitario Virgen del RocíoSevilla, 41013, Spain
Completed
Hospital Clínic i Provincial de BarcelonaBarcelona, 08036, Spain
Terminated
Hospital Clínico Universitario San CarlosMadrid, 28040, Spain
Completed
Complejo Hospitalario de OrenseOrense, 32005, Spain
Completed
McGill UniversityMontreal, H2W 1S6, Canada
Completed
CU Saint-Luc/UZ St-LucBRUXELLES - BRUSSEL, 1200, Belgium
Completed
Ziekenhuis Oost-LimburgGENK, 3600, Belgium
Terminated
ZNA MiddelheimANTWERPEN, 2020, Belgium
Completed
Grand Hôpital de CharleroiCHARLEROI, 6000, Belgium
Completed
St. Antonius ZiekenhuisNIEUWEGEIN, 3435 CM, Netherlands
Completed
Vrije Universiteit Medisch CentrumAmsterdam, 1081HV, Netherlands
Completed
Atrium Medisch Centrum ParkstadHEERLEN, 6419 PC, Netherlands
Completed
Ziekenhuis St. JansdalHARDERWIJK, 3844 DG, Netherlands
Completed
Elkerliek Ziekenhuis, Lokatie HelmondHELMOND, 5707 HA, Netherlands
Completed
Hadassah Hebrew University Hospital Ein KeremJerusalem, 9112001, Israel
Completed
District Dispensary for Oncology Diseases with InpatientPlovdiv, Bulgaria
Completed
Interdistrict Dispensary for Oncological Diseases Dr.M.MarkoVarna, 9002, Bulgaria
Completed
MHAT Sveta Marina EADVarna, 9010, Bulgaria
Terminated
Consultorios Médicos PrivadosRamos Mejía, B1704ESN, Argentina
Terminated
Hospital Privado de CórdobaCórdoba, X5016KEH, Argentina
Completed
Krankenhaus der Elisabethinen LinzLinz, 4010, Austria
Completed
Pest County Lung InstituteTorokbalint, 2045, Hungary
Completed
Zala Megyei KorhazZalaegerszeg, 8900, Hungary
Completed
Orszagos Koranyi TBC es Pulmonologiai IntezetBudapest, 1529, Hungary
Completed
Hospital e Maternidade BrasilSanto André, 09020 110, Brazil
Completed
Hospital Israelita Albert EinsteinSão Paulo, 05651-900, Brazil
Completed
Irmandade Santa Casa de Misericordia de Porto AlegrePorto Alegre, 90050 170, Brazil
Completed
Sahlgrenska UniversitetssjukhusetGöteborg, 413 45, Sweden
Completed
Universitetssjukhuset i LinköpingLinköping, 581 85, Sweden
Completed
University of Pretoria, Prinshof CampusPrietoria, 0084, South Africa
Terminated
Medcial Oncology Centre RosebankJohannesburg, 2196, South Africa
Terminated
Panorama GVI OncologyCape Town, 7500, South Africa
Completed
Edith Wolfson Medical CenterHolon, Israel
Completed
Rabin Medical Center - Beilinson CampusPetach Tikva, 4941492, Israel
Completed
District Dispensary for Oncology Diseases with InpatientSofia, 1784, Bulgaria
Completed
Specialized Hospital for Active Treatment of OncologySofia, Bulgaria
Terminated
Centro Especializado ISISSanta Fé, S3000FFV, Argentina
Terminated
Centro Oncológico de RosarioRosario, S2000DSK, Argentina
Terminated
Instituto Oncológico Dr. J. M. UrrutiaCórdoba, 5000, Argentina
Terminated
Instituto C.A.I.C.I.Rosario, 2000, Argentina
Terminated
PALIARBuenos Aires, C1430ERF, Argentina
Completed
Medizinische Universität GrazGraz, 8036, Austria
Completed
Instituto de Oncologia do ValeSão José dos Campos, 12245750, Brazil
Completed
Clinical Oncology DispensaryKazan, 420029, Russia
Terminated
Clinical Oncology HospitalYaroslavl, 150054, Russia
Completed
Shanghai Pulmonary Hospital, Tongji UniversityShanghai, 200433, China
Completed
Chinese PLA General Hosp.Beijing, 100853, China
Completed
Sir Run Run Shaw HospitalHangzhou, 310016, China
Completed
National Cancer Center DHARMAISJakarta, 11420, Indonesia
Completed
Asan Medical CenterSeoul, 138-736, Korea, Republic Of
Completed
Seoul St. Mary's HospitalSeoul, 137-701, Korea, Republic Of
Completed
National Taiwan University HospitalTaipei, 10016, Taiwan
Completed
Taichung Veterans General HospitalTaichung, 40705, Taiwan
Completed
Kaohsiung Medical University HospitalKaohsiung, 80756, Taiwan
Completed
Hospital Edgardo Rebagliati MartinsLima, LIMA 11, Peru
Completed
Hospital Nacional Guillermo Almenara IrigoyenLima, LIMA 1, Peru
Terminated
Princess Margaret HospitalKowloon, Hong Kong
Terminated
Allgemeines Krankenhaus der Stadt Wien UniversitätsklinikenWien, 1090, Austria
Completed
Instituto Nacional del CancerSantiago, 838-0455, Chile
Completed
Hospital Clínico Universidad de ChileSantiago, 838-0456, Chile
Completed
Veszprem County Pulmonology InstituteFarkasgyepu, 8582, Hungary
Completed
Ege Universitesi Tip FakultesiIzmir, Turkey
Completed
Marmara University Medical FacultyINSTANBUL, 34662, Turkey
Completed
Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, Turkey
Completed
Anadolu Saglik MerkeziKocaeli, 41400, Turkey
Completed
Ankara Universitesi Tip FakultesiAnkara, Turkey
Completed
University General Hospital of HeraklionHeraklion, 711 10, Greece
Completed
Sotiria General State Hospital of Chest DiseasesAthens, 11527, Greece
Completed
G. Papanikolaou General Hospital of ThessalonikiThessaloniki, 570 10, Greece
Completed
Grupo de Assistencia Medica e Prestacao de Servicos LtdaSao Paulo, 01224-010, Brazil
Completed
Veterans Memorial Medical CenterQuezon City, 1104, Philippines
Completed
Perpetual Succour HospitalCebu City, 6000, Philippines
Completed
Manila Doctors HospitalMetro Manila, 1000, Philippines
Completed
National University Cancer Institute, SingaporeSingapore, 119228, Singapore
Completed
Johns Hopkins Singapore IMCSingapore, 308433, Singapore
Completed
Maharaj Nakorn Chiang Mai HospitalChiang Mai, 50200, Thailand
Completed
Mayo HospitalLahore, 54000, Pakistan
Completed
BioCancerBelo Horizonte, 30150-281, Brazil
Completed
Hospital Sao Lucas da Pontificia Universidade Catolica do RSPorto Alegre, 90610-000, Brazil
Terminated
Centro Especializado en Oncología y Hematología BrasiliaBrasilia, 70680-650, Brazil
Completed
Railways Hospital named after SemashkoMoscow, 129128, Russia
Completed
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMSMoscow, 115478, Russia
Completed
City Clinical Oncology CenterSt. Petersburg, 198255, Russia
Terminated
Moscow Clinical Oncology Dispensary n. 1Moscow, 105 005, Russia
Completed
Russian Oncological Scientific Center n.a. N.N. Blokhin RAMSMoscow, 115478, Russia
Completed
Cancer Hospital, Chinese Academy of Medical SciencesBeijing, 100021, China
Completed
Guangdong General HospitalGuangzhou, 510080, China
Completed
Sun Yat-sen University Cancer CenterGuangzhou, 510060, China
Completed
Shanghai Chest Hospital, Shanghai Jiaotong UniversityShanghai, 200030, China
Completed
PLA 81 HospitalNanjing, 210002, China
Completed
Peking University Cancer HospitalBeijing, 100142, China
Completed
307 Hospital of PLABeijing, 100071, China
Completed
Zhejiang Cancer HospitalHangzhou, 310022, China
Completed
West China Hospital, Sichuan UniversityChengdu, 610041, China
Terminated
Hasan Sadikin HospitalBandung, 40161, Indonesia
Completed
Korea University Anam HospitalSeoul, 136-705, Korea, Republic Of
Completed
Seoul National University HospitalSeoul, 110-744, Korea, Republic Of
Completed
Samsung Medical CenterSeoul, 135-710, Korea, Republic Of
Completed
Curie Manavata Cancer CentreMumbai, 422004, India
Completed
Lakeshore Hospital and Research Center LtdKerala, 682304, India
Completed
Ruby Hall ClinicPune, 411001, India
Completed
Chang Gung Memorial Hospital at LinkouTaoyuan, 333, Taiwan
Completed
China Medical University HospitalTaichung, 404, Taiwan
Terminated
Clínica El GolfLima, LIMA 27, Peru
Completed
Hospital Alberto Sabogal SologurenCallao, CALLAO 2, Peru
Terminated
OncosaludSan Borja, Peru
Completed
Prince of Wales HospitalShatin, Hong Kong
Completed
Queen Mary HospitalHongkong, Hong Kong
Completed
Santo Tomás University HospitalManila, 1000, Philippines
Completed
Siriraj Hospital, MahidolBangkok, 10700, Thailand
Completed
Prince of Songkla UniversitySongkhla, 90110, Thailand
Completed
Dr Ziauddin HospitalKarachi, 74700, Pakistan
Completed
Centre Hospitalier Départemental-La Roche sur YonLA ROCHE SUR YON CEDEX, 85025, France
Completed
Koch Robert HospitalEdeleny, 3780, Hungary
Completed
University of SemmelweisBudapest, 1125, Hungary
Terminated
Rittenhouse Hematology/OncologyPhiladelphia, 19107, United States
Completed
Zentralklinik Bad Berka GmbHBad Berka, 99437, Germany
Terminated
Klinikum Innenstadt der Ludwigs-Maximilians-UniversitätMünchen, 80336, Germany
Terminated
Klinikum Mannheim gGmbHMannheim, 68167, Germany
Terminated
Klinikum Kassel GmbHKassel, 34125, Germany
Completed
Universitätsklinikum UlmUlm, 89091, Germany
Terminated
Instituto Nacional de Enfermedades NeoplásicasLima, LIMA 34, Peru

Primary Outcome

  • Overall survival
    date_rangeTime Frame:
    From randomization of the first subject until 36 months later
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Progression-free survival
    date_rangeTime Frame:
    From randomization of the first subject until 36 months later assessed every 6 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Disease control
    date_rangeTime Frame:
    From randomization of the first subject until 36 months later assessed every 6 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Objective tumor response
    date_rangeTime Frame:
    From randomization of the first subject until 36 months later assessed every 6 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Time to progression
    date_rangeTime Frame:
    From randomization of the first subject until 36 months later assessed every 6 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health status
    date_rangeTime Frame:
    Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer module (EORTC QLQ-LC13) - coughing subscale
    date_rangeTime Frame:
    Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer module (EORTC QLQ-LC13) - dyspnea
    date_rangeTime Frame:
    Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in EuroQol-5D (EQ-5D) - index score
    date_rangeTime Frame:
    Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)
    enhanced_encryption
    Safety Issue:
    No
  • Mean change from baseline in EuroQol-5D (EQ-5D) - VAS score
    date_rangeTime Frame:
    Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)
    enhanced_encryption
    Safety Issue:
    No

Trial design

A Phase III, multi-center, placebo–controlled trial of Sorafenib (BAY43-9006) in patients with relapsed or refractory advanced predominantly non squamous Non-Small Cell Lung Cancer (NSCLC) after 2 or 3 previous treatment regimens for advanced disease
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2