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NCT07288177RecruitingPhase 2

Study to Assess the Efficacy and Safety of Rina-S in Participants With Non-small Cell Lung Cancer

A Phase 2, Open-label, Multicohort Study of Rinatabart Sesutecan (Rina-S) in Participants With Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

This Phase 2 study will be conducted in different countries around the world with up to about 240 participants. The purpose of this study is to evaluate how well Rina-S works against lung cancer. The treatment in this study is Rina-S monotherapy (by itself). All participants will receive active drug; no one will be given placebo. The treatment duration will be different for every participant, but an average of 12 months is expected. Participants will be asked to attend 1 to 5 visits at the study clinic for each cycle (duration of cycle is 3 weeks). If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open. Participation in the study will require visits to the study site(s). During site visits, there will be various tests (such as blood draws) and procedures (such as recording of heart activity, imaging/X-rays) to monitor whether the study treatment is safe and effective.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
240 (estimated)
First submitted
15 Dec 2025
Start date
30 Jan 2026
Primary completion date
22 Nov 2027
Lead sponsor
Genmab
Diseases
Lung cancer
NCT number
NCT07288177
EU CT number
2025-522107-18-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 240
  • From 30 Jan 2026 to the primary completion date, 22 Nov 2027
  • 123 sites in 14 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

  • Participant has a past or current malignancy other than the inclusion diagnosis before the planned first dose of trial treatment, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (eg, 5-year OS ≥ 90%), including, but not limited to, adequately treated cervical carcinoma of stage 1B or less, in situ basal cell or squamous cell skin carcinoma, in situ bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥ 3 years.
  • Participants with newly identified or known unstable (eg, progressing brain metastases) or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis (also known as leptomeningeal disease). Participants with history of spinal cord compression (from disease). Participants with previous CNS-directed therapy (eg, radiotherapy and/or surgery) for brain metastases may participate provided lesion(s) are radiologically stable (ie, without evidence of progression) for at least 28 days by repeat imaging.
    • Note: Other protocol-defined Inclusion and Exclusion criteria may apply.

Other

  • Participant has NSCLC with histology other than adenocarcinoma

Who the study is looking for

  • Participant has histologically or cytologically confirmed metastatic or locally advanced NSCLC of adenocarcinoma histology, not amenable to curative surgery or radiotherapy.
  • Participant must have radiological disease progression while on or after receiving the most recent regimen.
  • Participants either may have actionable genetic alterations (AGAs) or no AGAs.
  • Participant has measurable disease according to RECIST v1.1.
  • Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1 within 7 days of Cycle 1 Day 1.

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

Full criteria on ClinicalTrials.gov

Sites (123)

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

SiteCityCountrySite status
St Andrews Medical Centre
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AdelaideAustraliaRecruiting
Blacktown Hospital
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BlacktownAustraliaRecruiting
Chris O'Brien Lifehouse
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CamperdownAustraliaRecruiting
St Vincent's Hospital Melbourne
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FitzroyAustraliaRecruiting
Icon Cancer Centre Hobart
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HobartAustraliaRecruiting
Icon Cancer Care - Townsville
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Hyde ParkAustraliaRecruiting
Icon Cancer Centre Townsville ICON Cancer Care - Townsville
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Hyde ParkAustraliaRecruiting
St George Hospital
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KogarahAustraliaRecruiting
St John of God Murdoch Hospital
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MurdochAustraliaRecruiting
Sir Charles Gairdner Hospital
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NedlandsAustraliaRecruiting
GenesisCare North Shore
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Saint LeonardsAustraliaRecruiting
Institut Jules Bordet
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AnderlechtBelgiumRecruiting
Universitair Ziekenhuis Antwerpen
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EdegemBelgiumRecruiting
JESSA Ziekenhuis
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HasseltBelgiumRecruiting
Chu Helora
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La LouvièreBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
Centre Hospitalier Universitaire de Liège
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LiègeBelgiumRecruiting
Algemeen Ziekenhuis Delta
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RoeselareBelgiumRecruiting
Beijing Cancer Hospital
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BeijingChinaRecruiting
Beijing Chest Tumor Hospital
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BeijingChinaRecruiting
Jilin Provincial Cancer Hospital
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ChangchunChinaRecruiting
Nanjing Medical University (NMU) - Jiangsu Province Hospital (First Affiliated Hospital)
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NanjingChinaRecruiting
Shanghai East Hospital
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ShanghaiChinaRecruiting
Tianjin Medical University Cancer Institute and Hospital
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TianjinChinaRecruiting
The First Affiliated Hospital of Hebei North University
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ZhangjiakouChinaRecruiting
Henan Cancer Hospital
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ZhengzhouChinaRecruiting
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
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BerlinGermanyRecruiting
Universitaetsklinikum Koeln AöR
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CologneGermanyRecruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyRecruiting
Justus-Liebig-Universitaet Giessen
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GiessenGermanyRecruiting
Martha-Maria Krankenhaus Halle-Doelau gGmbH
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Halle (saale)GermanyRecruiting
Medizinische Hochschule Hannover
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HanoverGermanyRecruiting
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyRecruiting
Heidelberg University
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MannheimGermanyRecruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainRecruiting
Institut Catala d'Oncologia
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BadalonaSpainRecruiting
Hospital Clinic de Barcelona
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BarcelonaSpainRecruiting
Hospital del Mar
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BarcelonaSpainRecruiting
Instituto Oncologico Dr. Rosell S.L.
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BarcelonaSpainRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
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
Fundacion Rioja Salud
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LogronoSpainRecruiting
MD Anderson Cancer Center
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MadridSpainRecruiting
Hospital Clínico San Carlos
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MadridSpainRecruiting
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainRecruiting
Clinica Universidad de Navarra
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MadridSpainRecruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Hospital Quironsalud Malaga
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MálagaSpainRecruiting
Clínica Universidad de navarra
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PamplonaSpainRecruiting
Hospital Clinico Universitario de Valencia
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ValenciaSpainRecruiting
Fundación Instituto Valenciano de Oncología
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ValenciaSpainRecruiting
Hospices Civils de Lyon
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BronFranceRecruiting
Hospices Civils De Lyon
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Lyon Cedex 04FranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Institut Curie
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ParisFranceRecruiting
Assistance Publique Hopitaux de Paris
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ParisFranceRecruiting
Fondation Hôpital Saint-Joseph
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ParisFranceRecruiting
Hospices Civils de Lyon
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Pierre-BéniteFranceRecruiting
Clinic Of Pulmonology Semmelweis University
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Budapest ViiiHungaryRecruiting
Bacs-Kiskun Varmegyei Oktatokorhaz
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KecskemétHungaryRecruiting
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
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TatabányaHungaryRecruiting
Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCS
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CandioloItalyRecruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyRecruiting
Istituto Europeo di Oncologia s.r.l
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MilanItalyRecruiting
Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli
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NaplesItalyRecruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyRecruiting
Istituto Oncologico Veneto
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PadovaItalyRecruiting
Azienda Ospedaliero Universitaria Parma
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ParmaItalyRecruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyRecruiting
I.F.O. Istituti Fisioterapici Ospitalieri
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RomeItalyRecruiting
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
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RomeItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
National Cancer Center - Tsukiji Campus
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ChūōJapanRecruiting
Kyoto Prefectural University of Medicine
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KyotoJapanRecruiting
Japan Community Health Care Organization Chukyo Hospital
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NagoyaJapanRecruiting
Kitasato University Hospital
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SagamiharaJapanRecruiting
Saitama Medical University International Medical Center
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SaitamaJapanRecruiting
NHO Kinki-Chuo Chest Medical Center
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SakaiJapanRecruiting
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital
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TokyoJapanRecruiting
Kanagawa Cardiovascular and Respiratory Center
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YokohamaJapanRecruiting
Chungbuk National University Hospital
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Cheongju-siSouth KoreaRecruiting
Keimyung University Dongsan Hospital
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DaeguSouth KoreaRecruiting
Gachon University Gil Medical Center
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IncheonSouth KoreaRecruiting
Korea University Anam Hospital
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SeoulSouth KoreaRecruiting
The Catholic University of Korea St. Vincent's Hospital
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SuwonSouth KoreaRecruiting
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
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AmsterdamNetherlandsRecruiting
Leids Universitair Medisch Centrum (LUMC)
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LeidenNetherlandsRecruiting
Radboud universitair medisch centrum Stichting
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NijmegenNetherlandsRecruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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RotterdamNetherlandsRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Przychodnia Lekarska Komed Roman Karaszewski
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KoninPolandRecruiting
Instytut MSF Sp. z o.o.
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LodzPolandRecruiting
Med Polonia Sp z o.o.
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PoznanPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Changhua Christian Hospital
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ChanghuaTaiwanRecruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanRecruiting
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
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New Taipei CityTaiwanRecruiting
National Cheng Kung University
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TainanTaiwanRecruiting
Chi Mei Medical Center - Liouying
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TainanTaiwanRecruiting
National Taiwan University Hospital NTUH
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TaipeiTaiwanRecruiting
ONE Onc: New York Oncology Hematology
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AlbanyUnited StatesRecruiting
Emory Winship Cancer Institute
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AtlantaUnited StatesRecruiting
St. Vincent Frontier Cancer Center
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BillingsUnited StatesRecruiting
UNC Health - University of North Carolina
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Chapel HillUnited StatesRecruiting
Baylor Charles A. Sammons Cancer Center
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DallasUnited StatesRecruiting
Astera Cancer Care
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East BrunswickUnited StatesRecruiting
Williamette Valley Cancer Institute and Research Center
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EugeneUnited StatesRecruiting
Virginia Cancer Specialists
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FairfaxUnited StatesRecruiting
Compassionate Cancer Care Center
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Fountain ValleyUnited StatesRecruiting
City of Hope Orange County Lennar Foundation Cancer Center
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IrvineUnited StatesRecruiting
Nebraska Hematology-Oncology
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LincolnUnited StatesRecruiting
University of Miami Hospital
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MiamiUnited StatesRecruiting
Tennessee Oncology - Nashville St. Thomas Midtown Clinic
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NashvilleUnited StatesRecruiting
Tennessee Oncology Nashville - SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
Providence Portland Medical Center
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PortlandUnited StatesRecruiting
Kaiser Permanente San Diego Mission Road
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San DiegoUnited StatesRecruiting
Providence Medical Foundation (St. Joseph Heritage Healthcare)
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Santa RosaUnited StatesRecruiting
Moffitt Cancer Center and Research Institute
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TampaUnited StatesRecruiting
Montefiore Medical Park
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The BronxUnited StatesRecruiting
MedStar Georgetown University Hospital
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Washington D.C.United StatesRecruiting
Providence Oncology & Hematology Care Clinic - Westside
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West Haven-SylvanUnited StatesRecruiting

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