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NCT06881784RecruitingPhase 3

Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)

RASolve 301: Phase 3 Multicenter, Open Label, Randomized Study of RMC-6236 Versus Docetaxel in Patients With Previously Treated Locally Advanced or Metastatic RAS[MUT] NSCLC

Source: ClinicalTrials.gov · Last updated 29 Sept 2026

Brief summary (registry, in English)

The purpose of this study is to evaluate the safety and efficacy of a novel RAS(ON) inhibitor compared to docetaxel.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
590 (estimated)
First submitted
10 Mar 2025
Start date
6 May 2025
Primary completion date
1 Dec 2027
Lead sponsor
Revolution Medicines, Inc.
Diseases
Lung cancer
NCT number
NCT06881784
EU CT number
2024-518154-16-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 590
  • From 6 May 2025 to the primary completion date, 1 Dec 2027
  • 189 sites in 19 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

  • Prior therapy with direct RAS-targeted therapy or docetaxel.
  • Ongoing anticancer therapy.

Other illness

  • Medically significant comorbidities (significant cardiovascular disease, lung disease, or impaired GI function).

Other

  • Untreated central nervous system (CNS) metastases.
  • Pregnant or breastfeeding.

Who the study is looking for

  • At least 18 years old and has provided informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Pathologically confirmed NSCLC, either locally advanced or metastatic, not amenable to curative surgery or radiotherapy.
  • Measurable disease per RECIST v1.1.
  • Adequate organ function (bone marrow, liver, kidney, coagulation).
  • One to two prior lines of therapy including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy.
  • Documented RAS mutation status, defined as Nonsynonymous mutations in KRAS, NRAS, or HRAS at codons 12, 13, or 61 (G12, G13, or Q61).
  • Able to take oral medications.

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

Full criteria on ClinicalTrials.gov

Sites (189)

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

SiteCityCountrySite status
Blacktown Medical Oncology Research
Coordinator of this site? Confirm its status
BlacktownAustraliaRecruiting
Blacktown Medical Oncology Research, Blacktown Hospital
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BlacktownAustraliaRecruiting
Chris O'Brien Lifehouse
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CamperdownAustraliaRecruiting
St. George Private Hospital Clinical Trials Unit
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KogarahAustraliaRecruiting
Alfred House
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MelbourneAustraliaRecruiting
Sir Charles Gairdner Hospital
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PerthAustraliaRecruiting
Mater Misericordiae Limited
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South BrisbaneAustraliaRecruiting
Calvary Mater Newcastle
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WaratahAustraliaRecruiting
Institut Jules Bordet
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AnderlechtBelgiumActive, not recruiting
Grand Hopital de Charleroi
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CharleroiBelgiumActive, not recruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumActive, not recruiting
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumActive, not recruiting
UZ Leuven
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LeuvenBelgiumActive, not recruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumActive, not recruiting
Universitätsspital Basel
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BaselSwitzerlandRecruiting
HFR Fribourg/Kantonsspital Fribourg
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FribourgSwitzerlandRecruiting
Kantonsspital St. Gallen
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Sankt GallenSwitzerlandRecruiting
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
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BerlinGermanyActive, not recruiting
Technische Universitaet Dresden
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DresdenGermanyActive, 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
Justus-Liebig-Universitaet Giessen
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GiessenGermanyActive, not recruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyActive, not recruiting
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyActive, not recruiting
Lungenfachklinik Immenhausen
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ImmenhausenGermanyActive, not recruiting
Klinikum der Universität zu Köln
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KölnGermanyActive, not recruiting
Universitaetsklinikum Schleswig-Holstein AöR
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LuebeckGermanyActive, not recruiting
Muenchen Klinik gGmbH
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MunichGermanyActive, not recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitari Dexeus Grupo Quironsalud
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BarcelonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital Universitario de Jaén
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JaénSpainRecruiting
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainRecruiting
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainRecruiting
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital Universitario HM Sanchinarro
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MadridSpainRecruiting
Hospital Universitario Ramón y Cajal
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario La Paz
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MadridSpainRecruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainRecruiting
Hospital Universitario Regional de Málaga
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MálagaSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Institut Bergonie
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BordeauxFranceActive, 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 Intercommunal Creteil
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Creteil CedexFranceActive, not recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceActive, 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 Regional De Marseille
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MarseilleFranceActive, not recruiting
Institut Regional Du Cancer De Montpellier
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Montpellier Cedex 5FranceActive, not recruiting
Institut Curie
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ParisFranceActive, not recruiting
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceActive, not recruiting
Centre Hospitalier Universitaire De Rennes
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Rennes Cedex 9FranceActive, not recruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceActive, not recruiting
Institut De Cancerologie De L Ouest
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Saint-Herblain CedexFranceActive, not recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceActive, not recruiting
Institut Gustave Roussy
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VillejuifFranceActive, not recruiting
The Clatterbridge Cancer Centre
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LiverpoolUnited KingdomRecruiting
Royal Free Hospital
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LondonUnited KingdomRecruiting
Royal Marsden Hospital - London
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LondonUnited KingdomRecruiting
The Christie NHS Foundation Trust
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ManchesterUnited KingdomRecruiting
Royal Marsden Hospital (Sutton)
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SuttonUnited KingdomRecruiting
Hong Kong United Oncology Centre
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Hong KongHong Kong SAR ChinaRecruiting
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaRecruiting
Princess Margaret Hospital
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Lai Chi KokHong Kong SAR ChinaRecruiting
The Chinese University of Hong Kong
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ShatinHong Kong SAR ChinaRecruiting
Cork University Hospital
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CorkIrelandActive, not recruiting
Tallaght University Hospital
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Dublin 24IrelandActive, not recruiting
St Vincent's University Hospital
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Dublin 4IrelandActive, not recruiting
Mater Private Hospital
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Dublin 7IrelandActive, not recruiting
Beaumont Hospital
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Dublin 9IrelandActive, not recruiting
University Hospital Galway
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GalwayIrelandActive, not recruiting
University Hospital Limerick
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LimerickIrelandActive, not recruiting
Istituto Europeo di Oncologia s.r.l
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
Coordinator of this site? Confirm its status
MilanItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
Coordinator of this site? Confirm its status
NaplesItalyRecruiting
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyRecruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyRecruiting
Azienda Ospedaliero Universitaria Parma
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ParmaItalyRecruiting
Azienda Ospedaliera di Perugia
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PerugiaItalyRecruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyRecruiting
I.F.O. Istituti Fisioterapici Ospitalieri
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Coordinator of this site? Confirm its status
RomeItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Azienda Ospedaliera Universitaria Integrata Verona
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VeronaItalyRecruiting
Hyogo Cancer Center
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AkashiJapanRecruiting
National Cancer Center Hospital
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Chuo KuJapanRecruiting
Saitama Medical University International Medical Center
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HidakaJapanRecruiting
Kansai Medical University Hospital
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Hirakata-shiJapanRecruiting
Kanazawa University Hospital
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KanazawaJapanRecruiting
Nara Medical University Hospital
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Kashihara-shiJapanRecruiting
National Cancer Center Hospital East
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Kashiwa-shiJapanRecruiting
Cancer Institute Hospital of JFCR
Coordinator of this site? Confirm its status
Koto-KuJapanRecruiting
University Hospital Kyoto Prefectural University of Medicine
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KyotoJapanRecruiting
NHO Himeji Medical Center
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MatsuyamaJapanRecruiting
NHO Shikoku Cancer Center
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MatsuyamaJapanRecruiting
Shizuoka Cancer Center
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Nagaizumi-chōJapanRecruiting
Aichi Cancer Center Hospital
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NagoyaJapanRecruiting
Niigata Cancer Center
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NiigataJapanRecruiting
Kindai University Hospital
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Osakasayama-ShiJapanRecruiting
Kitasato University Hospital
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SagamiharaJapanRecruiting
National Hospital Organization Hokkaido Cancer Center
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SapporoJapanRecruiting
Tohoku University Hospital
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SendaiJapanRecruiting
Sendai Kousei Hospital
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SendaiJapanRecruiting
Fujita Health University Hospital
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Toyoake-shiJapanRecruiting
Wakayama Medical University Hospital
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WakayamaJapanRecruiting
Kanagawa Cancer Center
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YokohamaJapanRecruiting
Chungbuk National University Hospital
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Cheongju-siSouth KoreaRecruiting
Ajou University Hospital
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Gyeonggi-doSouth KoreaRecruiting
Chonnam National University Hwasun Hospital
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HwasunSouth KoreaRecruiting
Korea University Anam Hospital
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SeoulSouth KoreaRecruiting
Samsung Medical Center
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Coordinator of this site? Confirm its status
AmsterdamNetherlandsActive, not recruiting
Amsterdam UMC Stichting
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AmsterdamNetherlandsActive, not recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
Academisch Ziekenhuis Maastricht
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MaastrichtNetherlandsActive, not recruiting
Radboud universitair medisch centrum Stichting
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NijmegenNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsActive, not recruiting
Auckland City Hospital - Cancer and Blood Research
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GraftonNew ZealandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
INSTYTUT GENETYKI I IMMUNOLOGII GENIM Sp z o o
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LublinPolandActive, not recruiting
Med Polonia Sp z o.o.
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PoznanPolandActive, not recruiting
Aidport sp z o.o.
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SkorzewoPolandActive, not recruiting
Pan American Center for Oncology Trials
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San JuanPuerto RicoRecruiting
National University Hospital
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SingaporeSingaporeRecruiting
Icon Cancer Centre
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SingaporeSingaporeRecruiting
National Cancer Centre Singapore
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SingaporeSingaporeRecruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
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KaohsiungTaiwanRecruiting
National Cheng Kung University Hospital
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TainanTaiwanRecruiting
Taipei Medical University Hospital
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TaipeiTaiwanRecruiting
National Taiwan University Hospital
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TaipeiTaiwanRecruiting
Chang Gung Medical Foundation - Linkou
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TaoyuanTaiwanRecruiting
Avera Saint Luke's Hospital
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AberdeenUnited StatesRecruiting
Trinity Health Ann Arbor Hospital
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Ann ArborUnited StatesRecruiting
University Cancer and Blood Center
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AthensUnited StatesRecruiting
Piedmont Healthcare, Inc
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AtlantaUnited StatesRecruiting
Winship Cancer Institute
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AtlantaUnited StatesRecruiting
Texas Oncology South Austin
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AustinUnited StatesRecruiting
Johns Hopkins University of Medicine
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BaltimoreUnited StatesRecruiting
University of Iowa Health Care Cancer Services Quad Cities
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BettendorfUnited StatesRecruiting
St. Vincent Frontier Cancer Center
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BillingsUnited StatesRecruiting
Alabama Oncology
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BirminghamUnited StatesRecruiting
Roswell Park Cancer Institute
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BuffaloUnited StatesRecruiting
UNC Lineberger Comprehensive Cancer Center at University of North Carolina
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Chapel HillUnited StatesRecruiting
Center for Care and Discovery
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ChicagoUnited StatesRecruiting
University of Illinois Cancer Center
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ChicagoUnited StatesRecruiting
TriHealth Cancer & Blood Institute Research
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CincinnatiUnited StatesRecruiting
Texas Oncology - Dallas
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DallasUnited StatesRecruiting
Karmanos Cancer Institute
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DetroitUnited StatesRecruiting
Henry Ford Health
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DetroitUnited StatesRecruiting
Oncology Associates Of Oregon, Pc
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EugeneUnited StatesRecruiting
Virginia Cancer Specialists
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FairfaxUnited StatesRecruiting
Florida Cancer Specialists & Research Institute - South
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Fort MyersUnited StatesRecruiting
John Theurer Cancer Center At Hackensack UMC
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HackensackUnited StatesRecruiting
Penn State Milton S. Hershey Medical Center
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HersheyUnited StatesRecruiting
MD Anderson Cancer Center
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HoustonUnited StatesRecruiting
University of Iowa Hospitals & Clinics
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Iowa CityUnited StatesRecruiting
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesRecruiting
MemorialCare Long Beach Medical Center
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Long BeachUnited StatesRecruiting
Taylor Cancer Research Center
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MaumeeUnited StatesRecruiting
Morristown Medical Center (MMCORC)
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MorristownUnited StatesRecruiting
SCRI Oncology Partners - Tennessee
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NashvilleUnited StatesRecruiting
Yale University, Smillow Cancer Center
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New HavenUnited StatesRecruiting
Memorial Sloan-Kettering Cancer Center
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New YorkUnited StatesRecruiting
BRCR global
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PlantationUnited StatesRecruiting
Cancer Care Centers of Breevard
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RockledgeUnited StatesRecruiting
Huntsman Cancer Institute
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Salt Lake CityUnited StatesRecruiting
Utah Cancer Specialists
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Salt Lake CityUnited StatesRecruiting
Avera Cancer Institute
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Sioux FallsUnited StatesRecruiting
Washington University School of Medicine - Siteman Cancer Center
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St LouisUnited StatesRecruiting
Florida Cancer Specialists & Research Institute - North
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St. PetersburgUnited StatesRecruiting
Cleveland Clinic Martin North
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StuartUnited StatesRecruiting
Montefiore Medical Center
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The BronxUnited StatesRecruiting
Texas Oncology- Gulf Coast
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The WoodlandsUnited StatesRecruiting
University of Iowa Health Care, Mission Cancer + Blood
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WaukeeUnited StatesRecruiting
Florida Cancer Specialists & Research Institute - East
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West Palm BeachUnited StatesRecruiting
The University of Kansas Cancer Center
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WestwoodUnited StatesRecruiting

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