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NCT07541170RecruitingPhase 3

A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)

A Phase III, Randomized, Open-label Study Evaluating the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Patients With Resected Stage II-III KRAS G12C-Positive Non-small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 13 Oct 2026

Brief summary (registry, in English)

The main purpose of this study is to evaluate the efficacy of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
400 (estimated)
First submitted
14 Apr 2026
Start date
6 Oct 2026
Primary completion date
31 Jan 2032
Lead sponsor
Hoffmann-La Roche
NCT number
NCT07541170
EU CT number
2025-524263-21-01

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 400
  • From 6 Oct 2026 to the primary completion date, 31 Jan 2032
  • 119 sites in 20 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 design.

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 treatment with a KRAS inhibitor or any other anti-cancer therapy not otherwise specified in the protocol
  • Prior treatment with radiation therapy for NSCLC, with the exception of localized symptom-directed radiation prior to surgical resection
  • Resolved Grade 3 or greater immune-related AE or unresolved Grade 2 or greater immune-related AE from neoadjuvant immunotherapy

Other illness

  • Active or history of autoimmune disease or immune deficiency
  • Significant cardiovascular disease

Other

  • Participants who achieve pCR following neoadjuvant treatment

Who the study is looking for

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histological or cytological diagnosis of clinical Stage II-IIIB NSCLC of either non-squamous or squamous histology
  • Participants must have had complete resection of NSCLC
  • Prior treatment with neoadjuvant immune checkpoint inhibitor (pembrolizumab or nivolumab) in combination with histology-based platinum-based doublet chemotherapy
  • Participants must be randomized within 12 weeks of their surgery date
  • No evidence of disease recurrence or metastatic disease
  • Documentation of the presence of a KRAS G12C mutation

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

Full criteria on ClinicalTrials.gov

Sites (119)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Instituto Argentino de Diagnóstico y Tratamiento- IADT
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Capital FederalArgentinaRecruiting
Clinica Adventista Belgrano
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Ciudad Autonoma Buenos AiresArgentinaRecruiting
Centro Oncologico Korben
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Ciudad Autonoma Buenos AiresArgentinaRecruiting
Hospital Britanico
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Ciudad Autonoma Buenos AiresArgentinaRecruiting
Hospital Privado de Comunidad
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Mar del PlataArgentinaRecruiting
Sanatorio de la Mujer
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RosarioArgentinaRecruiting
Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
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FeldkirchAustriaNot yet recruiting
Medizinische Universitaet Innsbruck
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InnsbruckAustriaNot yet recruiting
Universitaetsklinikum Krems
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Krems An Der DonauAustriaNot yet recruiting
Johannes Kepler University Linz
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LinzAustriaNot yet recruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumNot yet recruiting
JESSA Ziekenhuis
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HasseltBelgiumNot yet recruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumNot yet recruiting
CHU Helora
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MonsBelgiumNot yet recruiting
Cenantron Centro Avançado de Tratamento Oncológico
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Belo HorizonteBrazilRecruiting
Clínica de Neoplasias Litoral
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ItajaíBrazilRecruiting
Hospital Sao Lucas - PUCRS
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Porto AlegreBrazilRecruiting
Hospital Moinhos de Vento
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Porto AlegreBrazilRecruiting
Beneficencia Portuguesa de Sao Paulo
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São PauloBrazilRecruiting
Jewish General Hospital
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MontrealCanadaRecruiting
Guangdong General Hospital
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GuangzhouChinaRecruiting
Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo
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Bogota, D.C.ColombiaRecruiting
Clinica ASTORGA
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MedellínColombiaRecruiting
Vivantes Netzwerk fuer Gesundheit GmbH
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BerlinGermanyRecruiting
Evangelisches Klinikum Bethel gGmbH
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BielefeldGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Klinikum Esslingen GmbH
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Esslingen am NeckarGermanyRecruiting
Asklepios Klinik Gauting GmbH
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GautingGermanyRecruiting
Universitaetsklinikum des Saarlandes AöR
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HomburgGermanyRecruiting
Sana Klinikum Offenbach GmbH
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Offenbach Am MainGermanyRecruiting
Pius Hospital Oldenburg
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OldenburgGermanyRecruiting
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
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RegensburgGermanyRecruiting
Klinikum Der Landeshauptstadt Stuttgart gKAöR
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StuttgartGermanyRecruiting
Klinikum Wuerzburg Mitte gGmbH
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WuerzburgGermanyRecruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Hospital Germans Trias i Pujol
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BadalonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainRecruiting
Hospital Universitario Basurto
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BilbaoSpainRecruiting
Hospital Universitario Clínico San Cecilio
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GranadaSpainRecruiting
Hospital Universitari Arnau De Vilanova De La Gerencia Territorial De Lleida
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LleidaSpainRecruiting
Hospital Universitario 12 de Octubre
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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 Virgen de la Victoria
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MálagaSpainRecruiting
Hospital Son Llatzer
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PalmaSpainRecruiting
Salut Sant Joan de Reus
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ReusSpainRecruiting
Parc Tauli Hospital Universitari
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SabadellSpainRecruiting
Hospital Universitario Nuestra Señora de Candelaria
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Santa Cruz de TenerifeSpainRecruiting
Hospital Universitario San Juan de Alicante
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Sant Joan d'AlacantSpainRecruiting
University Hospital Virgen Del Rocio S.L.
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SevillaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
Hospital Universitario Miguel Servet
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ZaragozaSpainRecruiting
Centre Hospitalier d'Avignon
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AvignonFranceNot yet recruiting
Hospices Civils de Lyon
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BronFranceNot yet recruiting
Centre Francois Baclesse
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Caen Cedex 5FranceNot yet recruiting
University Hospital Of Clermont-Ferrand
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Clermont Ferrand Cedex 1FranceNot yet recruiting
Centre Leon Berard
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LyonFranceNot yet recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceNot yet recruiting
Centre Hospitalier Intercommunal De Cornouaille
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Quimper CedexFranceNot yet recruiting
Centre Hospitalier Universitaire Reims
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Reims CedexFranceNot yet recruiting
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceNot yet recruiting
Les Hopitaux Universitaires De Strasbourg
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Strasbourg CedexFranceNot yet recruiting
Hospital Foch
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SuresnesFranceNot yet recruiting
Institut Gustave Roussy
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VillejuifFranceNot yet recruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceRecruiting
Henry Dunant Hospital Center
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AthensGreeceRecruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceRecruiting
General University Hospital of Larissa
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LarissaGreeceRecruiting
Athens Medical Center S.A.
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MaroussiGreeceRecruiting
St. Luke's Hospital S.A.
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ThessalonikiGreeceRecruiting
Athens Medical Center S.A.
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ThessalonikiGreeceRecruiting
Queen Mary Hospital
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Hong KongHong KongRecruiting
Prince of Wales Hosp
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ShatinHong KongRecruiting
Cork University Hospital
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CorkIrelandRecruiting
St James's Hospital
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Dublin 8IrelandRecruiting
University Hospital Galway
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GalwayIrelandRecruiting
Cliniche Gavazzeni S.p.A.
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BergamoItalyRecruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyRecruiting
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyRecruiting
Ospedale San Raffaele S.r.l.
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MilanItalyRecruiting
Azienda Ospedaliero - Universitaria di Modena
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ModenaItalyRecruiting
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyRecruiting
Hospital Santa Maria Della Misericordia
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PerugiaItalyRecruiting
Ospedale P. Pederzoli Casa di Cura Privata S.p.A.
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Peschiera del GardaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyRecruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
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TurinItalyRecruiting
Gifu University Hospital
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GifuJapanRecruiting
Kobe University Hospital
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HyōgoJapanRecruiting
Pusan National University Hospital
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BusanSouth KoreaRecruiting
Yeungnam University Medical Center
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DaeguSouth KoreaRecruiting
Chungnam National University Hospital
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DaejeonSouth KoreaRecruiting
Ajou University Medical Center
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Gyeonggi-doSouth KoreaRecruiting
Gachon University Gil Medical Center
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IncheonSouth KoreaRecruiting
Chonnam National University Hwasun Hospital
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Jeollanam-doSouth KoreaRecruiting
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaRecruiting
Asan Medical Center
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SeoulSouth KoreaRecruiting
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaRecruiting
Zuyderland Medisch Centrum Stichting
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GeleenNetherlandsNot yet recruiting
Jeroen Bosch Ziekenhuis Stichting
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'S-HertogenboschNetherlandsNot yet recruiting
Centrum Pulmonologii i Torakochirurgii w Bystrej
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BystraPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej w Kielcach
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KielcePolandRecruiting
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandRecruiting
National Institute Of Tuberculosis And Lung Diseases
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WarsawPolandRecruiting
Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii
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WroclawPolandRecruiting
Instituto Portugues De Oncologia De Coimbra Francisco Gentil E.P.E.
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CoimbraPortugalRecruiting
Hospital Cuf Tejo S.A.
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LisbonPortugalRecruiting
Champalimaud Clinical Centre
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LisbonPortugalRecruiting
Unidade Local De Saude De Loures-Odivelas EPE
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LouresPortugalRecruiting
Unidade Local de Saude de Sao Joao E.P.E.
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PortoPortugalRecruiting
Unidade Local de Saúde de Gaia/Espinho, E. P. E
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Vila Nova de GaiaPortugalRecruiting
Piedmont Cancer Institute, PC
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AtlantaUnited StatesRecruiting
Community Cancer Institute (CCI)
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ClovisUnited StatesRecruiting
San Juan Oncology Associates
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FarmingtonUnited StatesRecruiting
Profound Research, LLC
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Farmington HillsUnited StatesRecruiting
Renown Regional Medical Center
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RenoUnited StatesRecruiting
Cancer Care Specialists
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RenoUnited StatesRecruiting

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