Trial Condition(s):

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). (MISSION)

Bayer Identifier:

13266

ClinicalTrials.gov Identifier:

NCT00863746

EudraCT Number:

2008-006914-62

EU CT Number:

Not Available

Study Completed

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.

Inclusion Criteria
- 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  </=1.5 x the upper limit of normal
 -- Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases)
Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases)
 -- Alkaline phosphatase < 4 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases)
 -- 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
Exclusion Criteria
- 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
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Krankenhaus Grosshansdorf

Großhansdorf, Germany, 22927

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Asklepios Fachkliniken München Gauting

Gauting, Germany, 82131

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Asklepios Klinik Harburg

Hamburg, Germany, 21075

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St. Vincentius-Kliniken gAG

Karlsruhe, Germany, 76137

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Royal Marsden NHS Trust (Surrey)

Sutton, United Kingdom, SM2 5PT

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Royal Marsden Hospital (London)

London, United Kingdom, SW3 6JJ

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Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

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Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ

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Southmead Hospital

Bristol, United Kingdom, BS10 5NB

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Highlands Oncology Group

Fayetteville, United States, 72703

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Centre Georges Francois Leclerc Dijon

DIJON, France, 21000

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Hôpital de la Croix Rousse

LYON CEDEX, France, 69317

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Hôpital Bretonneau - Tours

TOURS, France, 37044

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Kliniken der Stadt Köln - Städt. Krankenhaus Köln-Merheim

Köln, Germany, 51109

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Thoraxklinik-Heidelberg gGmbH

Heidelberg, Germany, 69126

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St James' University Hospital

Leeds, United Kingdom, LS9 7TF

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Royal Free Hospital

London, United Kingdom, NW3 2QG

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Christie Hospital

Greater Manchester, United Kingdom, M20 4BX

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Stanford Hospital & Clinics

Stanford, United States, 94305

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Centre René Gauducheau - Nantes

SAINT HERBLAIN, France, 44805

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Specjalistyczny Szpital im. prof. Alfreda Sokolowskiego

Szczecin, Poland, 70-891

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Szpital Miejski sw. Aleksandra

Kielce, Poland, 25-316

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Kinki University Hospital

Osakasayama, Japan, 589-8511

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Kinki-Chuo Chest Medical Center

Sakai, Japan, 591-8555

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National Cancer Center Hospital East

Kashiwa, Japan, 277-8577

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A.O. San Camillo-Forlanini

Roma, Italy, 00151

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A.O.U. di Perugia

Perugia, Italy, 06156

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A.O. San Gerardo di Monza

Monza, Italy, 20052

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Centre Oscar Lambret

Lille, France, 59020

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Center Hospitalier Michallon - Grenoble

LA TRONCHE, France, 38700

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Centre François Baclesse - CLCC - Caen

CAEN, France, 14073

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Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

Krakow, Poland, 31-115

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Instytut Gruzlicy i Chorob Pluc

Warszawa, Poland, 01-138

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NZOZ MRUKMED 2 Sp. p., Przychodnia Specjalistyczna

Rzeszow, Poland, 35-021

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Samodzielny Publiczny Zespól Gruzlicy i Chorób Pluc

Olsztyn, Poland, 10-357

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Teikyo University Hospital

Itabashi-ku, Japan, 173-8606

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The Cancer Institute Hospital of JFCR

Koto-ku, Japan, 135-8550

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Hyogo Cancer Center

Akashi, Japan, 673-8558

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National Kyushu Cancer Center

Fukuoka, Japan, 811-1395

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Aichi Cancer Center Hospital

Nagoya, Japan, 464-8681

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IRCCS Istituto Clinico Humanitas

Rozzano, Italy, 20089

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A.O.U. di Parma

Parma, Italy, 43100

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AUSL 06 Livorno - Toscana

Livorno, Italy, 57124

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A.O.U. San Luigi Gonzaga

Orbassano, Italy, 10043

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A.O. San Giuseppe Moscati

Avellino, Italy, 83100

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Hospital Regional Carlos Haya

Málaga, Spain, 29010

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Complejo Hospitalario de Zamora

Zamora, Spain, 49021

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Hospital de Cruces

Cruces/Barakaldo, Spain, 48903

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Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08025

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Hospital Universitario Arnau de Vilanova de Lleida

Lleida, Spain, 25198

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Hopsital Lucus Agustí

Lugo, Spain, 27003

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Isala Klinieken, Locatie Sophia

ZWOLLE, Netherlands, 8025 AB

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Skånes Universitetssjukhus

Lund, Sweden, 221 85

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Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 171 76

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Falu Lasarett

Falun, Sweden, 791 82

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Langehoven Drive Oncology Centre

Port Elizabeth, South Africa, 6045

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Dr Pirjol, Szpak 7 Moodley

Durban, South Africa, 4126

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Meir Medical Center

Kfar Saba, Israel, 4428164

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Assaf Harofeh Medical Center

Zrifin, Israel, 6093000

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Shaare Zedek Medical Center

Jerusalem, Israel, 9372212

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IRCCS Ist Nazionale Tumori GE

Genova, Italy, 16132

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Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

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Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

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Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

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Complejo Hospitalario de Orense

Orense, Spain, 32005

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McGill University

Montreal, Canada, H2W 1S6

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CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

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Ziekenhuis Oost-Limburg

GENK, Belgium, 3600

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ZNA Middelheim

ANTWERPEN, Belgium, 2020

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Grand Hôpital de Charleroi

CHARLEROI, Belgium, 6000

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St. Antonius Ziekenhuis

NIEUWEGEIN, Netherlands, 3435 CM

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Vrije Universiteit Medisch Centrum

Amsterdam, Netherlands, 1081HV

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Atrium Medisch Centrum Parkstad

HEERLEN, Netherlands, 6419 PC

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Ziekenhuis St. Jansdal

HARDERWIJK, Netherlands, 3844 DG

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Elkerliek Ziekenhuis, Lokatie Helmond

HELMOND, Netherlands, 5707 HA

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Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel, 9112001

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District Dispensary for Oncology Diseases with Inpatient

Plovdiv, Bulgaria

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Interdistrict Dispensary for Oncological Diseases Dr.M.Marko

Varna, Bulgaria, 9002

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MHAT Sveta Marina EAD

Varna, Bulgaria, 9010

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Consultorios Médicos Privados

Ramos Mejía, Argentina, B1704ESN

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Hospital Privado de Córdoba

Córdoba, Argentina, X5016KEH

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Krankenhaus der Elisabethinen Linz

Linz, Austria, 4010

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Pest County Lung Institute

Torokbalint, Hungary, 2045

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Zala Megyei Korhaz

Zalaegerszeg, Hungary, 8900

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Orszagos Koranyi TBC es Pulmonologiai Intezet

Budapest, Hungary, 1529

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Hospital e Maternidade Brasil

Santo André, Brazil, 09020 110

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Hospital Israelita Albert Einstein

São Paulo, Brazil, 05651-900

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Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90050 170

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Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

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Universitetssjukhuset i Linköping

Linköping, Sweden, 581 85

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University of Pretoria, Prinshof Campus

Prietoria, South Africa, 0084

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Medcial Oncology Centre Rosebank

Johannesburg, South Africa, 2196

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Panorama GVI Oncology

Cape Town, South Africa, 7500

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Edith Wolfson Medical Center

Holon, Israel

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Rabin Medical Center - Beilinson Campus

Petach Tikva, Israel, 4941492

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District Dispensary for Oncology Diseases with Inpatient

Sofia, Bulgaria, 1784

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Specialized Hospital for Active Treatment of Oncology

Sofia, Bulgaria

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Centro Especializado ISIS

Santa Fé, Argentina, S3000FFV

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Centro Oncológico de Rosario

Rosario, Argentina, S2000DSK

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Instituto Oncológico Dr. J. M. Urrutia

Córdoba, Argentina, 5000

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Instituto C.A.I.C.I.

Rosario, Argentina, 2000

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PALIAR

Buenos Aires, Argentina, C1430ERF

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Medizinische Universität Graz

Graz, Austria, 8036

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Instituto de Oncologia do Vale

São José dos Campos, Brazil, 12245750

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Clinical Oncology Dispensary

Kazan, Russia, 420029

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Clinical Oncology Hospital

Yaroslavl, Russia, 150054

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Shanghai Pulmonary Hospital, Tongji University

Shanghai, China, 200433

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Chinese PLA General Hosp.

Beijing, China, 100853

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Sir Run Run Shaw Hospital

Hangzhou, China, 310016

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National Cancer Center DHARMAIS

Jakarta, Indonesia, 11420

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Asan Medical Center

Seoul, South Korea, 138-736

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Seoul St. Mary's Hospital

Seoul, South Korea, 137-701

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National Taiwan University Hospital

Taipei, Taiwan, China, 10016

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Taichung Veterans General Hospital

Taichung, Taiwan, China, 40705

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Kaohsiung Medical University Hospital

Kaohsiung , Taiwan, China, 80756

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Hospital Edgardo Rebagliati Martins

Lima, Peru, LIMA 11

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Hospital Nacional Guillermo Almenara Irigoyen

Lima, Peru, LIMA 1

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Princess Margaret Hospital

Kowloon, Hong Kong, China

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Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

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Instituto Nacional del Cancer

Santiago, Chile, 838-0455

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Hospital Clínico Universidad de Chile

Santiago, Chile, 838-0456

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Veszprem County Pulmonology Institute

Farkasgyepu, Hungary, 8582

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Ege Universitesi Tip Fakultesi

Izmir, Turkey

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Marmara University Medical Faculty

INSTANBUL, Turkey, 34662

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Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, Turkey

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Anadolu Saglik Merkezi

Kocaeli, Turkey, 41400

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Ankara Universitesi Tip Fakultesi

Ankara, Turkey

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University General Hospital of Heraklion

Heraklion, Greece, 711 10

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Sotiria General State Hospital of Chest Diseases

Athens, Greece, 11527

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G. Papanikolaou General Hospital of Thessaloniki

Thessaloniki, Greece, 570 10

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Grupo de Assistencia Medica e Prestacao de Servicos Ltda

Sao Paulo, Brazil, 01224-010

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Veterans Memorial Medical Center

Quezon City, Philippines, 1104

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Perpetual Succour Hospital

Cebu City, Philippines, 6000

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Manila Doctors Hospital

Metro Manila, Philippines, 1000

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National University Cancer Institute, Singapore

Singapore, Singapore, 119228

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Johns Hopkins Singapore IMC

Singapore , Singapore, 308433

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Maharaj Nakorn Chiang Mai Hospital

Chiang Mai , Thailand, 50200

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Mayo Hospital

Lahore, Pakistan, 54000

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BioCancer

Belo Horizonte, Brazil, 30150-281

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Hospital Sao Lucas da Pontificia Universidade Catolica do RS

Porto Alegre, Brazil, 90610-000

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Centro Especializado en Oncología y Hematología Brasilia

Brasilia, Brazil, 70680-650

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Railways Hospital named after Semashko

Moscow, Russia, 129128

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Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

Moscow, Russia, 115478

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City Clinical Oncology Center

St. Petersburg, Russia, 198255

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Moscow Clinical Oncology Dispensary n. 1

Moscow, Russia, 105 005

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Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China, 100021

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Guangdong General Hospital

Guangzhou, China, 510080

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Sun Yat-sen University Cancer Center

Guangzhou, China, 510060

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Shanghai Chest Hospital, Shanghai Jiaotong University

Shanghai, China, 200030

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PLA 81 Hospital

Nanjing, China, 210002

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Peking University Cancer Hospital

Beijing, China, 100142

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307 Hospital of PLA

Beijing, China, 100071

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Zhejiang Cancer Hospital

Hangzhou, China, 310022

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West China Hospital, Sichuan University

Chengdu, China, 610041

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Hasan Sadikin Hospital

Bandung , Indonesia, 40161

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Korea University Anam Hospital

Seoul, South Korea, 136-705

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Seoul National University Hospital

Seoul, South Korea, 110-744

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Samsung Medical Center

Seoul, South Korea, 135-710

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Curie Manavata Cancer Centre

Mumbai, India, 422004

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Lakeshore Hospital and Research Center Ltd

Kerala, India, 682304

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Ruby Hall Clinic

Pune, India, 411001

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Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan, China, 333

Locations

China Medical University Hospital

Taichung, Taiwan, China, 404

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Clínica El Golf

Lima, Peru, LIMA 27

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Hospital Alberto Sabogal Sologuren

Callao, Peru, CALLAO 2

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Oncosalud

San Borja, Peru

Locations

Prince of Wales Hospital

Shatin, Hong Kong, China

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Queen Mary Hospital

Hongkong, Hong Kong, China

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Santo Tomás University Hospital

Manila, Philippines, 1000

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Siriraj Hospital, Mahidol

Bangkok, Thailand, 10700

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Prince of Songkla University

Songkhla, Thailand, 90110

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Dr Ziauddin Hospital

Karachi, Pakistan, 74700

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Centre Hospitalier Départemental-La Roche sur Yon

LA ROCHE SUR YON CEDEX, France, 85025

Locations

Koch Robert Hospital

Edeleny, Hungary, 3780

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University of Semmelweis

Budapest, Hungary, 1125

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Rittenhouse Hematology/Oncology

Philadelphia , United States, 19107

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Zentralklinik Bad Berka GmbH

Bad Berka, Germany, 99437

Locations

Klinikum Innenstadt der Ludwigs-Maximilians-Universität

München, Germany, 80336

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Klinikum Mannheim gGmbH

Mannheim, Germany, 68167

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Klinikum Kassel GmbH

Kassel, Germany, 34125

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Universitätsklinikum Ulm

Ulm, Germany, 89091

Locations

Instituto Nacional de Enfermedades Neoplásicas

Lima, Peru, LIMA 34

Trial Design