Trial Condition(s):

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) (NEXUS)

Bayer Identifier:

12006

ClinicalTrials.gov Identifier:

NCT00449033

EudraCT Number:

2006-002688-26

EU CT Number:

Not Available

Study Completed

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)

Inclusion Criteria
- Age > 18 years old 
 - Stage IIIB (with cytologically confirmed malignant  pleural or pericardial effusion) or Stage IV histological or cytological confirmation of NSCLC of non-squamous cell carcinoma subtype. (thoracentesis or pericardiocentesis is not necessary if a biopsy of the original tumor is available to confirm diagnosis of NSCLC).
 - Patients with at least one measurable lesion. Lesions must be measured by CT-scan or MRI (Magnetic resonance imaging) according to Response Evaluation Criteria in Solid Tumors (RECIST, see Appendix 10.3)
 - Life expectancy of at least 12 weeks
 - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of first dose:
 - Hemoglobin >/= 9.0 g/dl (>/= 5.6 mmol/l) 
 - Absolute neutrophil count (ANC) >/= 1,500/mm3
 - Platelet count >/= 100,000/µl
 - Total bilirubin </= 1.5 x upper limit of normal
 - Alanine transaminase (ALT) and Aspartate transaminase (AST) </= 2.5 x upper limit of normal (</= 5 x upper limit of normal for patients with liver involvement of their cancer)
 - Alkaline Phosphatase </= 4 x upper limit of normal
 - PT-INR (Prothrombin Time - International Normalized Ratio) (international normalized ratio of PT) /PTT (Partial Thromboplastin Time) < 1.5 x upper limit of normal 
 - Serum Creatinine </= 1.5 times the upper limit of normal and Serum Creatinine Clearance >/= 70ml/min
 - Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to performing any study specific procedures.
 - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Exclusion Criteria
- Excluded medical conditions:
 -- Cardiac disease: Congestive heart failure > class II NYHA (New York Heart Association).  Patients must not have unstable angina (anginal symptoms at rest) or active coronary artery disease (CAD), or myocardial infarction within the past 6 months 
 -- Cardiac arrhythmias requiring anti-arrhythmic therapy 
 -- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
 -- History of HIV (Human immunodeficiency virus) infection or chronic hepatitis B or C
 -- Active clinically serious infections (> grade 2 NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 3.0)
 -- Patients with seizure disorder requiring medication (such as steroids or anti-epileptics)
 -- Known brain metastasis.  Patients with neurological symptoms should undergo a CT scan/MRI of the brain to exclude brain metastasis.
 -- History of organ allograft 
 -- Patients with evidence or history of bleeding diathesis or coagulopathy
 -- Patients undergoing renal dialysis
 -- Cancer other than NSCLC within 5 years prior to start of study treatment EXCEPT cervical carcinoma in situ, treated basal cell carcinoma, or superficial bladder tumors [Ta (Noninvasive tumor), Tis (Carcinoma in situ) & T1 (Tumor invades lamina propria)]
 -- Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
 -- Thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
 -- Pulmonary hemorrhage/bleeding event > Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 within 4 weeks of first dose of study drug
 -- Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug
 -- Serious, non-healing wound, ulcer, or bone fracture
 -- Uncorrected dehydration 
 -- Pregnant or breast-feeding patients.  Women of childbearing potential must have a negative pregnancy test performed within 7 days of the start of treatment.  Both men and women enrolled in this trial must use adequate birth control measures during the course of the trial.  The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
 -- Substance abuse, medical, psychological or social conditions that may interfere with the patient’s participation in the study or evaluation of the study results
 -- Known or suspected allergy to the investigational agent or any agent given in association with this trial
 -- Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study
 -- Patients unable to swallow oral medications 
 -- Any malabsorption condition 
 -- Patients with a hearing impairment (FOR GERMANY ONLY)
 -- NSCLC patients with squamous cell carcinoma diagnosis documented either by cytology or biopsy.

 - Excluded therapies and medications, previous and concomitant:
 -- Any prior systemic anticancer therapy including cytotoxic therapy, targeted agents, experimental therapy, adjuvant, or neo-adjuvant therapy for NSCLC
 -- Concomitant use of nephrotoxic drugs, ototoxic drugs, anticonvulsant, anti-gout treatment
 -- Radiotherapy during study or within 3 weeks of start of study drug.  (Palliative radiotherapy will be allowed as described in the Prior and Concomitant Therapy section)
 -- Radiotherapy during study or within 4 weeks of start of study drug.  (Palliative radiotherapy will be allowed as described in the Prior and Concomitant Therapy section) (FOR FRANCE ONLY)
 -- Major surgery, open biopsy or significant traumatic injury within 4 weeks of first dose of study drug (bronchoscopy is allowed)
 -- Granulocyte colony stimulating factor (GCSF) or Granulocyte macrophage colony stimulating factor (GMCSF), within 3 weeks of study entry (these growth factors may be used during the study thereafter).

Trial Summary

Enrollment Goal
904
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Asklepios Fachkliniken München Gauting

Gauting, Germany, 82131

Status
Completed
Locations

Thoraxklinik-Heidelberg gGmbH

Heidelberg, Germany, 69126

Status
Completed
Locations

Klinik Löwenstein gGmbH

Löwenstein, Germany, 74245

Status
Completed
Locations

Kliniken der Stadt Köln - Städt. Krankenhaus Köln-Merheim

Köln, Germany, 51109

Status
Completed
Locations

St. Vincentius-Kliniken gAG

Karlsruhe, Germany, 76137

Status
Completed
Locations

Universitätsklinikum Essen

Essen, Germany, 45122

Status
Completed
Locations

Asklepios Klinik Harburg

Hamburg, Germany, 21075

Status
Completed
Locations

Krankenhaus Hofheim am Taunus

Hofheim , Germany, 65719

Status
Completed
Locations

Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ

Status
Completed
Locations

New Cross Hospital

Wolverhampton, United Kingdom, WV10 0QP

Status
Completed
Locations

Centre René Gauducheau - Nantes

NANTES, France, 44805

Status
Completed
Locations

Clinique Sainte Marguerite - Hyères

HYERES, France, 83400

Status
Completed
Locations

Hôpital Sainte Marguerite - Marseille

MARSEILLE, France, 13275

Status
Completed
Locations

Krankenhaus Grosshansdorf

Großhansdorf, Germany, 22927

Status
Completed
Locations

St. Markus-Krankenhaus

Frankfurt, Germany, 60431

Status
Completed
Locations

Zentralklinik Bad Berka GmbH

Bad Berka, Germany, 99437

Status
Completed
Locations

Städtisches Klinikum "St. Georg" Leipzig

Leipzig, Germany, 04207

Status
Completed
Locations

Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

Status
Completed
Locations

Guy's Hospital

London, United Kingdom, SE1 9RT

Status
Completed
Locations

Leicester Royal Infirmary

Leicester, United Kingdom, LE1 5WW

Status
Terminated
Locations

Royal Marsden NHS Trust (Surrey)

Sutton, United Kingdom, SM2 5PT

Status
Completed
Locations

Queen Elizabeth Hospital

Birmingham, United Kingdom, B15 2TH

Status
Terminated
Locations

Royal Marsden Hospital (London)

London, United Kingdom, SW3 6JJ

Status
Completed
Locations

Centre Hospitalier Lyon Sud - Pierre Bénite

PIERRE BENITE, France, 69495

Status
Completed
Locations

Centre Hospitalier Universitaire - Grenoble

GRENOBLE, France, 38043

Status
Completed
Locations

Hôpital Bretonneau - Tours

TOURS, France, 37044

Status
Completed
Locations

Nouvel Hopital CIVIL-CHU Strasbourg

Strasbourg, France, 67901

Status
Completed
Locations

IRCCS Istituto Clinico Humanitas

Rozzano, Italy, 20089

Status
Completed
Locations

ARNAS Garibaldi

Catania, Italy, 95122

Status
Completed
Locations

A.O.U. di Bologna

Bologna, Italy, 40138

Status
Completed
Locations

IRCCS Fondazione San Raffaele

Milano, Italy, 20132

Status
Completed
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
Locations

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08025

Status
Completed
Locations

Hospital Arnau de Vilanova de Valencia

Valencia, Spain, 46015

Status
Completed
Locations

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Status
Terminated
Locations

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain, 15006

Status
Terminated
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
Locations

AZ Klina

BRASSCHAAT, Belgium, 2930

Status
Completed
Locations

Clinique Sainte-Elisabeth

NAMUR, Belgium, 5000

Status
Completed
Locations

CHU de Liège

LIEGE, Belgium, 4000

Status
Completed
Locations

Jeroen Bosch Ziekenhuis

DEN BOSCH, Netherlands, 5211 RW

Status
Completed
Locations

Hopital Européen Georges Pompidou - Paris

PARIS CEDEX 15, France, 75908

Status
Completed
Locations

Clinique du Mail - Grenoble

GRENOBLE, France, 38100

Status
Terminated
Locations

Centre de Radiologie Oncologie Médicale - Nimes

NIMES CEDEX 2, France, 30907

Status
Completed
Locations

Clinique Victor Hugo - Le Mans

LE MANS CEDEX 2, France, 72015

Status
Completed
Locations

Centre Catalan d'Oncologie

PERPIGNAN, France, 66000

Status
Terminated
Locations

Clinique Paulmy - Bayonne

BAYONNE, France, 64100

Status
Completed
Locations

A.O. San Camillo-Forlanini

Roma, Italy, 00152

Status
Completed
Locations

AUSL 06 Livorno - Toscana

Livorno, Italy, 57124

Status
Completed
Locations

A.O.U. Integrata Verona

Verona, Italy, 37134

Status
Completed
Locations

ASL Sassari - Sardegna

Sassari, Italy, 07100

Status
Completed
Locations

A.O.U. Careggi

Firenze, Italy, 50134

Status
Completed
Locations

AULSS 12 Veneziana - Veneto

Venezia, Italy, 30122

Status
Completed
Locations

A.O. San Gerardo di Monza

Monza, Italy, 20052

Status
Completed
Locations

IRCCS Centro di Riferimento Oncologico - CRO

Aviano, Italy, 33081

Status
Completed
Locations

Hospital General Universitario de Valencia

Valencia, Spain, 46014

Status
Completed
Locations

Consorci Sanitari de Terrassa

Terrassa, Spain, 08227

Status
Completed
Locations

Ziekenhuis Gelderse Vallei

Ede, Netherlands, 6716 RP

Status
Completed
Locations

Atrium Medisch Centrum Parkstad

HEERLEN, Netherlands, 6419 PC

Status
Completed
Locations

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Mexico, 44280

Status
Completed
Locations

Hospital Universitario "José Eleuterio González"

Monterrey, Mexico, 64460

Status
Completed
Locations

Instituto Nacional de Cancerología

México, Mexico, 14080

Status
Completed
Locations

Universitätsklinikum Innsbruck

Innsbruck, Austria, 6020

Status
Completed
Locations

Krankenhaus Hietzing

Wien, Austria, 1130

Status
Terminated
Locations

SMZ Baumgartner Höhe Otto Wagner Spital

Wien, Austria, 1140

Status
Terminated
Locations

Orszagos Koranyi TBC es Pulmonologiai Intezet

Budapest, Hungary, 1121

Status
Terminated
Locations

Fovarosi Onkormanyzat Szent Janos Korhaza es Eszak-Budai

Budapest, Hungary, 1125

Status
Terminated
Locations

Sotiria General State Hospital of Chest Diseases

Athens, Greece, 11527

Status
Completed
Locations

Sotiria General State Hospital of Chest Diseases

Athens, Greece, 11527

Status
Terminated
Locations

Santa Casa de Misericórdia da Bahia Hospital Santa Izabel

Salvador, Brazil, 40050410

Status
Completed
Locations

Hospital Lifecenter

Belo Horizonte, Brazil, 30110-090

Status
Completed
Locations

Hospital Virgen de la Victoria

Málaga, Spain, 29010

Status
Completed
Locations

Hospital Regional Carlos Haya

Málaga, Spain, 29010

Status
Completed
Locations

Hospital de Cruces

Cruces/Barakaldo, Spain, 48903

Status
Completed
Locations

Hospital Clínico Universitario de Valencia

Valencia, Spain, 46010

Status
Completed
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Terminated
Locations

Royal Victoria Hospital

Montreal, Canada, H3A 1A1

Status
Terminated
Locations

UZ Antwerpen

EDEGEM, Belgium, 2650

Status
Completed
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
Locations

Ziekenhuis St. Jansdal

HARDERWIJK, Netherlands, 3844 DG

Status
Completed
Locations

St. Antonius Ziekenhuis

NIEUWEGEIN, Netherlands, 3435 CM

Status
Completed
Locations

Meir Medical Center

Kfar Saba, Israel, 4428164

Status
Completed
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel, 5262000

Status
Completed
Locations

Kaplan Medical Center

Rehovot, Israel, 7610001

Status
Completed
Locations

Barzilai Medical Center

Ashkelon, Israel, 7830604

Status
Completed
Locations

Edith Wolfson Medical Center

Holon, Israel, 58100

Status
Completed
Locations

Hospital Amaral Carvalho

Jaú, Brazil, 17210-120

Status
Terminated
Locations

Hospital Universitário de Brasília

Brasília, Brazil, 70840 901

Status
Terminated
Locations

Instituto Nacional do Cancer

Rio de Janeiro, Brazil, 20231 050

Status
Terminated
Locations

Santo Andre Diagnostico e Terapeutica

Santo Andre, Brazil, 09090-780

Status
Completed
Locations

Hospital Israelita Albert Einstein

São Paulo, Brazil, 05651-901

Status
Terminated
Locations

Centro Goiano de Oncologia

Goiânia, Brazil, 74075040

Status
Terminated
Locations

Oncovida/Centro Médico Iguatemi

Salvador, Brazil, 41820 021

Status
Terminated
Locations

Hospital das Clínicas da Faculdade de Medicina da USP

São Paulo, Brazil, 05403-010

Status
Terminated
Locations

Shanghai Chest Hospital, Shanghai Jiaotong University

Shanghai, China, 200030

Status
Completed
Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China, 100021

Status
Completed
Locations

Tongji Hosp. of Huazhong Univ. of Science & Technology

Wuhan, China, 430030

Status
Completed
Locations

Shanghai Pulmonary Hospital, Tongji University

Shanghai, China, 200433

Status
Completed
Locations

Universitätsspital Basel

Basel, Switzerland, 4031

Status
Completed
Locations

Hôpital Cantonal Universitaire de Genève

Genéve, Switzerland, 1205

Status
Terminated
Locations

Krankenhaus der Elisabethinen Linz

Linz, Austria, 4010

Status
Completed
Locations

Csongrad Megyei Onkormanyzat Mellkasi Betegsegek Szakkorhaza

Deszk, Hungary, 6772

Status
Terminated
Locations

Matrai State Hospital

Matrahaza, Hungary, 3233

Status
Terminated
Locations

Fejer megyei Szent Gyorgy Korhaz

Szekesfehervar , Hungary, 8000

Status
Terminated
Locations

Pest County Lung Institute

Torokbalint, Hungary, 2045

Status
Terminated
Locations

University General Hospital of Heraklion

Heraklion, Greece, 711 10

Status
Completed
Locations

Faculdade de Medicina do ABC

Santo André, Brazil, 09060-870

Status
Terminated
Locations

Hospital Sao Lucas da Pontificia Universidade Catolica do RS

Porto Alegre, Brazil, 90610-000

Status
Completed
Locations

Irmandade da Santa Casa de Misericordia - Sao Paulo

São Paulo, Brazil, 01221020

Status
Completed
Locations

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90050 170

Status
Completed
Locations

Conjunto Hospitalar de Sorocaba

Sorocaba, Brazil, 18030-510

Status
Terminated
Locations

Office of Dr. Agnaldo Anelli

São Paulo, Brazil, 01331020

Status
Terminated
Locations

Nucleo de Oncologia de Salvador

Salvador, Brazil, 40170-070

Status
Terminated
Locations

Hosp. Araujo Jorge da Associação de Combate ao Câncer

Goiania, Brazil, 74605-070

Status
Terminated
Locations

Tampereen yliopistollinen sairaala, keskussairaala

Tampere, Finland, FIN-33521

Status
Completed
Locations

TYKS/Paimion Sairaala

Preitilä, Finland, 21540

Status
Completed
Locations

Sun Yat-sen University Cancer Center

Guangzhou, China, 510060

Status
Completed
Locations

PLA 81 Hospital

Nanjing, China, 210002

Status
Completed
Locations

Sir Run Run Shaw Hospital

Hangzhou, China, 310016

Status
Completed
Locations

Zhejiang Cancer Hospital

Hangzhou, China, 310022

Status
Completed
Locations

Inselspital Bern

Bern, Switzerland, 3010

Status
Completed
Locations

HUS, Meilahden sairaala

HUS, Finland, 00029

Status
Completed
Locations

Bank of Cyprus Oncology Centre

Nicosia, Cyprus, 2006

Status
Completed

Trial Design