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NCT06497556Active, not recruitingPhase 3

A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Patients With Previously Treated KRAS G12C-Positive Advanced or Metastatic Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to assess the safety and efficacy of divarasib compared to locally approved KRAS G12C inhibitors (sotorasib or adagrasib) in participants with KRAS G12C-positive (KRAS G12C +) advanced or metastatic non-small cell lung cancer (NSCLC).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
338 (actual)
First submitted
5 Jul 2024
Start date
23 Sept 2024
Primary completion date
19 May 2026
Lead sponsor
Hoffmann-La Roche
Diseases
Lung cancer
NCT number
NCT06497556
EU CT number
2024-510908-37-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 338
  • From 23 Sept 2024 to the primary completion date, 19 May 2026
  • 173 sites in 26 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

  • Known concomitant second oncogenic driver
  • Any infection that, in the opinion of the investigator, could impact patient safety, or treatment with therapeutic oral or IV antibiotics within 14 days prior to Day 1 of Cycle 1
  • Prior treatment with any KRAS G12C inhibitor or pan-KRAS/RAS inhibitor
  • More than 30 Gy of radiotherapy to the lung within 6 months of randomization
  • Unresolved toxicities from prior anticancer therapy

Other illness

  • Known hypersensitivity to any of the components of divarasib, or sotorasib or adagrasib
  • Malabsorption syndrome or other condition that would interfere with enteral absorption
  • Mixed small-cell lung cancer or large cell neuroendocrine histology
  • Leptomeningeal disease or carcinomatous meningitis
  • History of malignancy within 5 years prior to screening, with the exception of the cancer under investigation in this study and malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \>90%), such as adequately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

Other

  • Known and untreated, or active central nervous system (CNS) metastases
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures biweekly or more frequently
  • Uncontrolled tumor-related pain

Who the study is looking for

  • Unequivocal histologically or cytologically confirmed diagnosis of metastatic or locally advanced NSCLC not amenable to treatment with surgical resection or combined chemoradiation
  • Disease progression during or after treatment with at least one prior systemic therapy but no more than three lines of prior systemic therapy in the advanced or metastatic setting
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Documentation of the presence of a KRAS G12C mutation
  • Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 10-15 (15 preferred) unstained, freshly cut, serial slides with an associated pathology report
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Life expectancy of \>= 12 weeks

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

Full criteria on ClinicalTrials.gov

Sites (173)

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

SiteCityCountrySite status
Hospital Britanico
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Buenos AiresArgentinaUnknown status
Centro Oncologico Korben
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Ciudad Autonoma Buenos AiresArgentinaUnknown status
Krankenhaus Nord - Klinik Floridsdorf
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ViennaAustriaActive, not recruiting
Sunshine Coast University Hospital
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BirtinyaAustraliaUnknown status
Lyell McEwin Hospital
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Elizabeth ValeAustraliaUnknown status
Liverpool Hospital
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LiverpoolAustraliaUnknown status
Peter MacCallum Cancer Centre
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MelbourneAustraliaUnknown status
GenesisCare - North Shore
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St LeonardsAustraliaUnknown status
Onze-Lieve-Vrouwziekenhuis
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AalstBelgiumActive, not recruiting
GasthuisZusters Antwerpen
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AntwerpBelgiumActive, not recruiting
Antwerp University Hospital
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EdegemBelgiumActive, not recruiting
JESSA Ziekenhuis
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HasseltBelgiumActive, not recruiting
UZ Brussel
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JetteBelgiumActive, not recruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumActive, not recruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumActive, not recruiting
Cliniques Universitaires Saint-Luc
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Sint-Lambrechts-WoluweBelgiumActive, not recruiting
Vitaz
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Sint-NiklaasBelgiumActive, not recruiting
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
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YvoirBelgiumActive, not recruiting
Hospital de Cancer de Barretos
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BarretosBrazilUnknown status
Hospital Sao Rafael - HSR
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SalvadorBrazilUnknown status
Hospital de Base de Sao Jose do Rio Preto
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São José do Rio PretoBrazilUnknown status
Hospital Alemão Oswaldo Cruz
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São PauloBrazilUnknown status
Hospital Sirio Libanes
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São PauloBrazilUnknown status
William Osler Health Centre - Brampton Civic Hospital
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BramptonCanadaUnknown status
Jewish General Hospital
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MontrealCanadaUnknown status
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
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BerlinGermanyActive, not recruiting
Helios Klinikum Emil von Behring GmbH
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BerlinGermanyActive, not recruiting
Kliniken der Stadt Koeln gGmbH
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CologneGermanyActive, not recruiting
KEM I Evang. Kliniken Essen-Mitte gGmbH
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EssenGermanyActive, not recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyActive, not recruiting
Klinikum Esslingen GmbH
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Esslingen am NeckarGermanyActive, not recruiting
Asklepios Klinik Gauting GmbH
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GautingGermanyActive, not recruiting
LungenClinic Grosshansdorf GmbH
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GrosshansdorfGermanyActive, not recruiting
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyActive, not recruiting
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
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HemerGermanyActive, not recruiting
Universitaetsklinikum des Saarlandes AöR
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HomburgGermanyActive, not recruiting
SLK-Kliniken Heilbronn GmbH
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LoewensteinGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyActive, not recruiting
Universitaetsklinikum Muenster AöR
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MuensterGermanyActive, not recruiting
Muenchen Klinik gGmbH
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MunichGermanyActive, not recruiting
Universitaetsklinikum Regensburg AöR
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RegensburgGermanyActive, not recruiting
Klinikum Wuerzburg Mitte gGmbH
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WuerzburgGermanyActive, not recruiting
Aarhus Universitetshospital
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Aarhus NDenmarkActive, not recruiting
Herlev og Gentofte Hospital
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HerlevDenmarkActive, not recruiting
Regionshospitalet Goedstrup
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HerningDenmarkActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainActive, not recruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Hospital Universitario Virgen De Valme
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SevillaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Hospital Unviersitario Miguel Servet
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ZaragozaSpainActive, not recruiting
HUS-Yhtymae
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HelsinkiFinlandActive, not recruiting
Pohjois-Savon hyvinvointialue
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KuopioFinlandActive, not recruiting
Turku University Hospital
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TurkuFinlandActive, not recruiting
Centre Hospitalier Universitaire D'Angers
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AngersFranceActive, not recruiting
CHU De Bordeauxt
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Bordeaux CedexFranceActive, not recruiting
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceActive, not recruiting
Hospices Civils de Lyon
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BronFranceActive, not recruiting
Centre Hospitalier Universitaire de Lille
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LilleFranceActive, not recruiting
Centre Leon Berard
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LyonFranceActive, not recruiting
Centre Hospitalier Universitaire de Montpellier
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MontpellierFranceActive, not recruiting
Centre Antoine Lacassagne
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Nice Cedex 2FranceActive, not recruiting
Assistance Publique Hopitaux de Paris
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ParisFranceActive, not recruiting
Centre Hospitalier de Saint-Quentin
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Saint-QuentinFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceActive, not recruiting
HIA Sainte Anne
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Toulon Cedex 9FranceActive, not recruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceActive, not recruiting
Addenbrooke's Hospital
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CambridgeUnited KingdomUnknown status
Castle Hill Hospital
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CottinghamUnited KingdomUnknown status
Beatson West of Scotland Cancer Centre
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GlasgowUnited KingdomUnknown status
St James University Hospital
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LeedsUnited KingdomUnknown status
Guy's Hospital - Cancer Centre
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LondonUnited KingdomUnknown status
Royal Marsden Hospital - London
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LondonUnited KingdomUnknown status
Nottingham City Hospital
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NottinghamUnited KingdomUnknown status
Royal Marsden Hospital (Sutton)
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SuttonUnited KingdomUnknown status
Torbay Hospital
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TorquayUnited KingdomUnknown status
Henry Dunant Hospital Center
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AthensGreeceActive, not recruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceActive, not recruiting
General University Hospital of Larissa
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LarissaGreeceActive, not recruiting
Metropolitan Hospital
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PireasGreeceActive, not recruiting
St. Luke's Hospital S.A.
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ThessalonikiGreeceActive, not recruiting
Theageneio Cancer Hospital
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ThessalonikiGreeceActive, not recruiting
Tuen Mun Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Prince of Wales Hosp
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ShatinHong Kong SAR ChinaUnknown status
Istituto Tumori Bari Giovanni Paolo II
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BariItalyActive, not recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyActive, not recruiting
Azienda Ospedaliera Universitaria Mater Domini
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CatanzaroItalyActive, not recruiting
Azienda Unita Sanitaria Locale Della Romagna
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FaenzaItalyActive, not recruiting
Careggi University Hospital
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FlorenceItalyActive, not recruiting
IRCCS Ospedale Policlinico San Martino
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GenoaItalyActive, not recruiting
Azienda Unita Sanitaria Locale Della Romagna
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LugoItalyActive, not recruiting
Azienda Ospedaliera dei Colli
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NaplesItalyActive, not recruiting
Istituto Oncologico Veneto
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PadovaItalyActive, not recruiting
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
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PalermoItalyActive, not recruiting
Azienda Ospedaliero Universitaria Parma
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ParmaItalyActive, not recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyActive, not recruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyActive, not recruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyActive, not recruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyActive, not recruiting
Azienda Ospedaliero-Universitaria di Sassari
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SassariItalyActive, not recruiting
Azienda Sanitaria Universitaria Friuli Centrale
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UdineItalyActive, not recruiting
Kyushu University Hospital
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FukuokaJapanUnknown status
Sendai Kousei Hospital
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MiyagiJapanUnknown status
Kindai University Hospital
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OsakaJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
National Cancer Center Hospital
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TokyoJapanUnknown status
Wakayama Medical University Hospital
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WakayamaJapanUnknown status
St. Vincent's Hospital
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Gyeonggi-doSouth KoreaUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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Jeollanam-doSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
ARKE Estudios Clínicos S.A. de C.V.
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Mexico CityMexicoUnknown status
Rijnstate Ziekenhuis Stichting
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ArnhemNetherlandsActive, not recruiting
Amphia Hospital
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BredaNetherlandsActive, not recruiting
Ziekenhuis St Jansdal
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HarderwijkNetherlandsActive, not recruiting
Medical Center Haaglanden
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LeidschendamNetherlandsActive, not recruiting
Jeroen Bosch Ziekenhuis
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's-HertogenboschNetherlandsActive, not recruiting
Isala Klinieken Stichting
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ZwolleNetherlandsActive, not recruiting
Kujawsko Pomorskie Centrum Pulmonologii W Bydgoszczy
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BydgoszczPolandActive, not recruiting
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandActive, not recruiting
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
Instytut Centrum Zdrowia Matki Polki
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LodzPolandActive, not recruiting
Uniwersytecki Szpital Kliniczny nr 4 w Lublinie
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LublinPolandActive, not recruiting
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandActive, not recruiting
Wielkopolskie Centrum Pulmonologii i Torakochirurgii im. Eugenii i Janusza Zeylandow
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PoznanPolandActive, not recruiting
Kliniki Neuroradiochirurgii Sp. z o.o.
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RadomPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
National Institute Of Tuberculosis And Lung Diseases
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WarsawPolandActive, not recruiting
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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WroclawPolandActive, not recruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalActive, not recruiting
Unidade Local de Saúde de Coimbra, E.P.E.
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CoimbraPortugalActive, not recruiting
Champalimaud Clinical Centre
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LisbonPortugalActive, not recruiting
Unidade Local De Saude De Santo Antonio E.P.E.
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PortoPortugalActive, not recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalActive, not recruiting
Region Gaevleborg
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GavleSwedenCompleted
Uppsala University Hospital
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UppsalaSwedenCompleted
National Cancer Centre
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SingaporeSingaporeUnknown status
Siriraj Hospital
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BangkokThailandUnknown status
Vajira Hospital
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BangkokThailandUnknown status
Songklanagarind Hospital
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SongkhlaThailandUnknown status
National Taiwan University 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
University of Michigan
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Ann ArborUnited StatesUnknown status
Dana-Farber Cancer Institute
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BostonUnited StatesUnknown status
Tennessee Oncology PLLC - Chattanooga
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ChattanoogaUnited StatesUnknown status
University of Chicago Medical Center
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ChicagoUnited StatesUnknown status
Minnesota Oncology - Edina
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EdinaUnited StatesUnknown status
Oncology Associates of Oregon, P.C.
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EugeneUnited StatesUnknown status
JPS Health Network
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Fort WorthUnited StatesUnknown status
Banner Health MD Anderson AZ
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GilbertUnited StatesUnknown status
Cancer and Hematology Centers of Western Michigan
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Grand RapidsUnited StatesUnknown status
MD Anderson Cancer Center
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HoustonUnited StatesUnknown status
Texas Oncology - Northeast Texas
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LongviewUnited StatesUnknown status
UCLA Hematology / Oncology Clinic
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Los AngelesUnited StatesUnknown status
Los Angeles Cancer Network
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Los AngelesUnited StatesUnknown status
Taylor Cancer Research Center
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MaumeeUnited StatesUnknown status
Baptist Clinical Research Institute
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MemphisUnited StatesUnknown status
University of Miami
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MiamiUnited StatesUnknown status
Tennessee Oncology
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NashvilleUnited StatesUnknown status
Yale Cancer Center
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New HavenUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
Fox Chase Cancer Center
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PhiladelphiaUnited StatesUnknown status
Allegheny Cancer Center
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PittsburghUnited StatesUnknown status
Oregon Health Science University
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PortlandUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Florida Cancer Specialists - North;725 6th Ave South (St. Petersburg)
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St. PetersburgUnited StatesUnknown status
New England Cancer Specialists
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WestbrookUnited StatesUnknown status

Related publications

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