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NCT03178552Active, not recruitingPhase 2/3

A Study to Evaluate the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Participants With Non-Small Cell Lung Cancer (NSCLC)

A Phase II/III Multicenter Study Evaluating the Efficacy and Safety of Multiple Targeted Therapies as Treatments for Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Harboring Actionable Somatic Mutations Detected in Blood (B-FAST: Blood-First Assay Screening Trial)

Source: ClinicalTrials.gov · Last updated 3 Sept 2026

Brief summary (registry, in English)

This is a phase 2/3, global, multicenter, open-label, multi-cohort study designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or in combination in participants with unresectable, advanced or metastatic NSCLC determined to harbor oncogenic somatic mutations or positive by tumor mutational burden (TMB) assay as identified by a blood-based next-generation sequencing (NGS) circulating tumor DNA (ctDNA) assay.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
5 Jun 2017
Start date
22 Sept 2017
Primary completion date
30 Jun 2027
Lead sponsor
Hoffmann-La Roche
Diseases
Lung cancer
NCT number
NCT03178552
EU CT number
2023-507500-31-00
EudraCT number
2017-000076-28

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 1000
  • From 22 Sept 2017 to the primary completion date, 30 Jun 2027
  • 153 sites in 27 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Inability to swallow oral medication
  • Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction, or cerebrovascular accident within 3 months prior to randomization, unstable arrhythmias, or unstable angina
  • Either a concurrent condition or history of a prior condition that places the patient at unacceptable risk if he/she were treated with the study drug or confounds the ability to interpret data from the study

Other illness

  • History of malignancy other than NSCLC within 5 years prior to screening with the exception of malignancies with negligible risk of metastasis or death
  • Known active or uncontrolled human immunodeficiency virus (HIV) infection

Other

  • Women who are pregnant or lactating
  • Symptomatic, untreated CNS metastases
  • Inability to comply with other requirements of the protocol

Who the study is looking for

  • Histologically or cytologically confirmed diagnosis of unresectable Stage IIIb not amenable to treatment with combined modality chemoradiation (advanced) or Stage IV (metastatic) NSCLC
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
  • Measurable disease
  • Adequate recovery from most recent systemic or local treatment for cancer
  • Adequate organ function
  • Life expectancy greater than or equal to (\>/=) 12 weeks
  • For female participants of childbearing potential and male participants, willingness to use acceptable methods of contraception

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (153)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fundación CENIT para la Investigación en Neurociencias
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Buenos AiresArgentinaUnknown status
Hospital Italiano
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Buenos AiresArgentinaUnknown status
Hospital Britanico de Buenos Aires
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Ciudad Autonoma Buenos AiresArgentinaUnknown status
The Prince Charles Hospital
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ChermsideAustraliaUnknown status
Ashford Cancer Center Research
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Kurralta ParkAustraliaUnknown status
Royal North Shore Hospital
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St LeonardsAustraliaUnknown status
UZ Brussel
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JetteBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumCompleted
Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
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IjuíBrazilUnknown status
Hospital Sao Lucas - PUCRS
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Porto AlegreBrazilUnknown status
Instituto Nacional de Câncer - INCA
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Rio de JaneiroBrazilUnknown status
Instituto do Cancer do Estado de Sao Paulo - ICESP
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São PauloBrazilUnknown status
Royal Victoria Regional Health Centre
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BarrieCanadaUnknown status
William Osler Health System - Brampton Civic Hospital
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BramptonCanadaUnknown status
Cross Cancer Institute
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EdmontonCanadaUnknown status
London Health Sciences Centre · Victoria Hospital
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LondonCanadaUnknown status
Jewish General Hospital
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MontrealCanadaUnknown status
Lakeridge Health Center
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OshawaCanadaUnknown status
IUCPQ (Hôpital Laval)
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QuébecCanadaUnknown status
Saskatoon Cancer Centre
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SaskatoonCanadaUnknown status
Princess Margaret Cancer Center
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TorontoCanadaUnknown status
Sunnybrook Health Sciences Centre
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TorontoCanadaUnknown status
CancerCare Manitoba
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WinnipegCanadaUnknown status
Bradford Hill Centro de Investigaciones Clinicas
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RecoletaChileUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
The Second Xiangya Hospital of Central South University
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ChangshaChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Sichuan Cancer Hospital
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ChengduChinaUnknown status
The First Affiliated Hospital of Guangzhou Medical University Pharmacy
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GuangzhouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
Shandong Cancer Hospital
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JinanChinaUnknown status
The Second Affiliated Hospital to Nanchang University
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NanchangChinaUnknown status
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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NanjingChinaUnknown status
Fudan Unviversity Shanghai Cancer Center
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ShanghaiChinaUnknown status
First Affiliated Hospital of Medical College of Xi'an Jiaotong University
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Xi'anChinaUnknown status
Klinikum Esslingen GmbH
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Esslingen am NeckarGermanyCompleted
Asklepios Klinik Gauting GmbH
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GautingGermanyCompleted
Helios Dr. Horst Schmidt Kliniken Wiesbaden GmbH
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WiesbadenGermanyCompleted
Hospital General Universitario Dr. Balmis
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AlicanteSpainActive, not recruiting
Hospital Germans Trias i Pujol
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BadalonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario HM Sanchinarro
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Clínica Universidad de navarra
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PamplonaSpainActive, not recruiting
Hospital Universitario Quironsalud Madrid
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Pozuelo de AlarcónSpainActive, not recruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainActive, not recruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainActive, not recruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Prince of Wales Hosp
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ShatinHong Kong SAR ChinaUnknown status
Soroka Medical Center
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BeershebaIsraelUnknown status
Rambam Health Care Campus
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HaifaIsraelUnknown status
Meir Medical Center
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Kfar SabaIsraelUnknown status
Rabin MC
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Petah TikvaIsraelUnknown status
Chaim Sheba Medical Center
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Ramat GanIsraelUnknown status
Sourasky / Ichilov Hospital; Dept. of Oncology
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Tel AvivIsraelUnknown status
Centro di Riferimento Oncologico di Aviano
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AvianoItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
Azienda Socio-Sanitaria Territoriale di Cremona
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CremonaItalyActive, not recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyActive, not recruiting
European Institute Of Oncology S.r.l.
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MilanItalyActive, not recruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyActive, not recruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyActive, not recruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyActive, not recruiting
San Camillo Forlanini Hospital
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RomeItalyActive, not recruiting
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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Bunkyō CityJapanUnknown status
Kyushu University Hospital
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FukuokaJapanUnknown status
National Hospital Organization Kyushu Medical Center
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FukuokaJapanUnknown status
National Hospital Organization Kyushu Cancer Center
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FukuokaJapanUnknown status
Hiroshima University Hospital
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HiroshimaJapanUnknown status
Kanazawa University Hospital
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IshikawaJapanUnknown status
Kanagawa Cancer Center
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KanagawaJapanUnknown status
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanUnknown status
Shikoku Cancer Center
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MatsuyamaJapanUnknown status
Sendai Kousei Hospital
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MiyagiJapanUnknown status
Tohoku University Hospital
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MiyagiJapanUnknown status
Niigata University Medical & Dental Hospital
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NiigataJapanUnknown status
Niigata Cancer Center Hospital
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NiigataJapanUnknown status
Kindai University Hospital
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OsakaJapanUnknown status
Saga University Hospital
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SagaJapanUnknown status
Shizuoka Cancer Center
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ShizuokaJapanUnknown status
Juntendo University Hospital
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TokyoJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
Kyorin University Hospital
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TokyoJapanUnknown status
Fujita Health University Hospital
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Toyoake-shiJapanUnknown status
Wakayama Medical University Hospital
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WakayamaJapanUnknown status
National Hospital Organization Yamaguchi Ube Medical Center
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YamaguchiJapanUnknown status
National Cancer Center
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Gyeonggi-doSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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Jeollanam-doSouth KoreaUnknown status
Yonsei University Health System, Severance Hospital
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Health Pharma Professional Research
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Mexico CityMexicoUnknown status
Avix Investigación Clínica, S.C.
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MonterreyMexicoUnknown status
Oncologico Potosino
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San Luis Potosí CityMexicoUnknown status
Hospital Angeles Tijuana
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TijuanaMexicoUnknown status
Auckland City Hospital
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AucklandNew ZealandUnknown status
Hemato Oncología de Panamá Especializada
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Panama CityPanamaUnknown status
Hospital Nacional Edgardo Rebagliati Martins
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LimaPeruUnknown status
Instituto Peruano de Oncología y Radioterapia
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LimaPeruUnknown status
Instituto Nacional de Enfermedades Neoplasicas
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LimaPeruUnknown status
Clinica Ricardo Palma
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San IsidroPeruUnknown status
Krakowski Szpital Specjalistyczny Im. Sw. Jana Pawla II
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CracowPolandActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandActive, not recruiting
Mazowieckie Centrum Leczenia Chorób Płuc i Gruźlicy
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OtwockPolandActive, not recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
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PoznanPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Clinical Center of Serbia
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BelgradeSerbiaUnknown status
University Hospital Medical Center Bezanijska Kosa
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BelgradeSerbiaUnknown status
Institute for Pulmonary Diseases of Vojvodina
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KamenitzSerbiaUnknown status
Clinical Center Nis
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NišSerbiaUnknown status
Moscow City Oncology Hospital #62
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Moscovskaya OblastRussiaUnknown status
Principal Military Clinical Hospital n.a. N.N. Burdenko
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MoscowRussiaUnknown status
Clinical Oncology Dispensary
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OmskRussiaUnknown status
S-Pb clinical scientific practical center of specialized kinds of medical care (oncological)
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Saint PetersburgRussiaUnknown status
National Cancer Centre
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SingaporeSingaporeUnknown status
National University Hospital
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SingaporeSingaporeUnknown status
Faculty of Med. Siriraj Hosp.
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BangkokThailandUnknown status
Prince of Songkla University
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Hat YaiThailandUnknown status
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
National Taiwan Uni Hospital
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TaipeiTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
Chang Gung Medical Foundation - Linkou
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TaoyuanTaiwanUnknown status
St. Luke's University Health Network
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BethlehemUnited StatesUnknown status
Sarah Cannon Research Institute / Tennessee Oncology
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ChattanoogaUnited StatesUnknown status
Rocky Mountain Cancer Center
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DenverUnited StatesUnknown status
SCRI Florida Cancer Specialists South
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Fort MyersUnited StatesUnknown status
Comprehensive Cancer Centers of Nevada
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Las VegasUnited StatesUnknown status
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesUnknown status
University of Kentucky
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LexingtonUnited StatesUnknown status
Weill Cornell Medical College-New York Presbyterian Hospital
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New YorkUnited StatesUnknown status
Oregon HSU
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PortlandUnited StatesUnknown status
UC Davis
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SacramentoUnited StatesUnknown status
Florida Cancer Specialist, North Region
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St. PetersburgUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
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AdanaTurkey (Türkiye)Unknown status
Akdeniz University Medical Faculty; Medical Oncology Department
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AntalyaTurkey (Türkiye)Unknown status
Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
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EdirneTurkey (Türkiye)Unknown status
Marmara University Pendik Training and Research Hospital; Medikal Onkoloji
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IstanbulTurkey (Türkiye)Unknown status
Medipol University Medical Faculty; Oncology Department
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IstanbulTurkey (Türkiye)Unknown status
Medikal Park Izmir Hospital
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Kar??yakaTurkey (Türkiye)Unknown status
Hacettepe Uni Medical Faculty Hospital; Oncology Dept
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Sihhiye/AnkaraTurkey (Türkiye)Unknown status

This page is information, not medical advice. Discuss any trial with your doctor.