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NCT06667076RecruitingPhase 2

A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

A Phase 2b, Open-Label, Two-cohort Study of Subcutaneous Amivantamab in Combination With Lazertinib as First-Line Treatment, or Subcutaneous Amivantamab in Combination With Platinum-Based Chemotherapy as Second-line Treatment, for Common EGFR-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
480 (estimated)
First submitted
30 Oct 2024
Start date
16 Dec 2024
Primary completion date
23 May 2029
Lead sponsor
Janssen Research & Development, LLC
Diseases
Lung cancer
NCT number
NCT06667076
EU CT number
2025-520730-28-00

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 480
  • From 16 Dec 2024 to the primary completion date, 23 May 2029
  • 205 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

  • Had major surgery excluding placement of vascular access or tumor biopsy or had significant traumatic injury within 4 weeks before the first dose of anticancer treatments or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study
  • Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy should be treated prior to first dosing)
  • Received an investigational treatment that has not been cleared (based on at least 5 half lives of any pharmaceutical treatment) before the planned first dose of study treatment or is currently enrolled in an investigational study
  • Has a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment could likely interfere with any study endpoints of safety or the efficacy of the study treatment(s)

Other illness

  • Medical history of active interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis. Participants with medical history of radiation pneumonitis, including radiation pneumonitis which required steroid treatment, should consult with the medical monitor and eligibility be assessed on a case-by-case basis

Who the study is looking for

  • Have histologically or cytologically confirmed advanced or metastatic non-small cell lung cancer (NSCLC) that is not amenable to curative intent therapy
  • Epidermal growth factor resistance-mutation (EGFRm) must be an Ex19del or Ex21 L858R substitution, as detected by food and drug administration (FDA)-approved or other validated test in a clinical laboratory improvement amendments (CLIA)-certified laboratory (sites in the US), or an accredited local laboratory (sites outside of the US) in accordance with site standard of care. In the European union (EU), the local test must be Conformité Européenne (CE)-marked or an in-house laboratory-developed test from health institutions in the EU in accordance with Article 5(5) of the in vitro diagnostic regulations (IVDR ) 2071/746, as amended
  • Have at least 1 measurable lesion, according to RECIST version (v)1.1, that has not been previously irradiated
  • Any toxicities from prior systemic anticancer therapy must have resolved to national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 5.0 grade 1 or baseline level (except for alopecia \[any grade\], grade \<=2 peripheral neuropathy, or grade \<=2 hypothyroidism stable on hormone replacement)
  • Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1

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

Full criteria on ClinicalTrials.gov

Sites (205)

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

SiteCityCountrySite status
Ziekenhuis Oost-Limburg
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GenkBelgiumRecruiting
Universitair Ziekenhuis Gent
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GentBelgiumRecruiting
UZ Leuven
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LeuvenBelgiumRecruiting
CHU UCL Namur - Site Godinne
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YvoirBelgiumRecruiting
Universitaetsmedizin Greifswald KöR
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GreifswaldGermanyRecruiting
ST. ELISABETH-KRANKENHAUS LEIPZIG gGmbH des Katholischen Kirchenlehens St. Trinitatis
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LeipzigGermanyRecruiting
LMU Klinikum Muenchen AöR
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MunichGermanyRecruiting
Klinikum Der Landeshauptstadt Stuttgart gKAöR
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StuttgartGermanyRecruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainRecruiting
Hospital de Jerez de la Frontera
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Jerez de la FronteraSpainRecruiting
Hospital Universitario 12 de Octubre
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MadridSpainRecruiting
Complexo Hospitalario Universitario De Santiago
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Santiago de CompostelaSpainRecruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainRecruiting
HUS-Yhtymae
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HelsinkiFinlandRecruiting
Oulu University Hospital
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OuluFinlandRecruiting
Turku University Hospital
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TurkuFinlandRecruiting
Centre Hospitalier Regional Et Universitaire De Brest
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Brest Cedex 2FranceRecruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceRecruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceRecruiting
Institut De Cancerologie De L Ouest
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Saint-Herblain CedexFranceRecruiting
Guy's and St Thomas' NHS Foundation Trust
Coordinator of this site? Confirm its status
Greater LondonUnited KingdomRecruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
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LiverpoolUnited KingdomRecruiting
Royal Marsden Hospital 1
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LondonUnited KingdomRecruiting
The Christie NHS Foundation Trust - Christie Hospital
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ManchesterUnited KingdomRecruiting
Royal Marsden Hospital
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SuttonUnited KingdomRecruiting
Torbay Hospital-Devon
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TorquayUnited KingdomRecruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceRecruiting
Henry Dunant Hospital Center
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AthensGreeceRecruiting
Metaxa Cancer Center Hospital Of Piraeus
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PireasGreeceRecruiting
Theageneio Cancer Hospital
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ThessalonikiGreeceRecruiting
Athens Medical Center S.A.
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ThessalonikiGreeceRecruiting
Soroka Medical Center
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BeershebaIsraelRecruiting
Rambam Medical Center
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HaifaIsraelRecruiting
Meir Medical Center
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Kfar SabaIsraelRecruiting
Sheba medical center
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Ramat GanIsraelRecruiting
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyRecruiting
Istituto Oncologico Veneto
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PadovaItalyRecruiting
Azienda Unità Sanitaria Locale della Romagna
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RavennaItalyRecruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyRecruiting
Humanitas Mirasole S.p.A.
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RozzanoItalyRecruiting
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandRecruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandRecruiting
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandRecruiting
Centrum Pulmonologii I Torakochirurgii W Bystrej
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WilkowicePolandRecruiting
Auxilio Mutuo Cancer Center
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San JuanPuerto RicoRecruiting
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalRecruiting
Unidade Local De Saude Do Alto Ave E.P.E.
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GuimaraesPortugalRecruiting
Hospital Cuf Tejo S.A.
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LisbonPortugalRecruiting
Unidade Local De Saude De Loures-Odivelas EPE
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LouresPortugalRecruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, 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
King Saud University Medical City
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RiyadhSaudi ArabiaRecruiting
King Abdulaziz Medical City
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RiyadhSaudi ArabiaRecruiting
King Faisal Specialist Hospital & Research Center
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RiyadhSaudi ArabiaRecruiting
University of New Mexico
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AlbuquerqueUnited StatesCompleted
Accellacare of McFarland
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AmesUnited StatesActive, not recruiting
University of Michigan Health System
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Ann ArborUnited StatesCompleted
University Cancer And Blood Center LLC
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AthensUnited StatesCompleted
Grady Health System Correll Pavilion
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AtlantaUnited StatesRecruiting
Winship Cancer Institute, Emory University
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AtlantaUnited StatesActive, not recruiting
Piedmont Cancer Institute
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AtlantaUnited StatesActive, not recruiting
Piedmont Healthcare
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AtlantaUnited StatesCompleted
Texas Oncology South
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AustinUnited StatesActive, not recruiting
University of Maryland
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BaltimoreUnited StatesRecruiting
Baptist Lynn Cancer Institute
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Boca RatonUnited StatesActive, not recruiting
Dana-Farber Cancer Institute
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BostonUnited StatesActive, not recruiting
Boston University Medical Center
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BostonUnited StatesActive, not recruiting
Beth Israel Deaconess Medical Center
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BostonUnited StatesActive, not recruiting
Lankenau Institute for Medical Research Main Line Health Bryn Mawr Hospital
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Bryn MawrUnited StatesCompleted
The Oncology Institute of Hope and Innovation
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CerritosUnited StatesActive, not recruiting
Medical University of South Carolina
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CharlestonUnited StatesActive, not recruiting
Atrium Health
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CharlotteUnited StatesActive, not recruiting
Tennessee Oncology - Chattanooga
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ChattanoogaUnited StatesActive, not recruiting
Rush University Medical Center Rush University Cancer Center Chicago
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ChicagoUnited StatesActive, not recruiting
University of Illinois at Chicago
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ChicagoUnited StatesActive, not recruiting
Cincinnati Veterans Affairs Medical Center
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CincinnatiUnited StatesCompleted
University of Cincinnati
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CincinnatiUnited StatesCompleted
City of Hope Corona
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CoronaUnited StatesActive, not recruiting
UT Southwestern Medical Center
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DallasUnited StatesActive, not recruiting
Parkland Health and Hospital System
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DallasUnited StatesRecruiting
Texas Oncology - DFW
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DallasUnited StatesActive, not recruiting
Southern Cancer Center Pc
Coordinator of this site? Confirm its status
DaphneUnited StatesActive, not recruiting
Cancer Care Specialists of Central Illinois
Coordinator of this site? Confirm its status
DecaturUnited StatesCompleted
Saint Josephs Hospital Cancer Centers of Colorado
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DenverUnited StatesCompleted
National Jewish Health
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DenverUnited StatesCompleted
City of Hope
Coordinator of this site? Confirm its status
DuarteUnited StatesActive, not recruiting
Duke University Medical Center
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DurhamUnited StatesCompleted
Hematology-Oncology Associates of CNY
Coordinator of this site? Confirm its status
East SyracuseUnited StatesActive, not recruiting
Renovatio Clinical
Coordinator of this site? Confirm its status
El PasoUnited StatesCompleted
Oncology Associates of Oregon PC Willamette Valley Cancer Institute
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EugeneUnited StatesActive, not recruiting
Virginia Cancer Specialists
Coordinator of this site? Confirm its status
FairfaxUnited StatesActive, not recruiting
University of Kansas Cancer Center
Coordinator of this site? Confirm its status
FairwayUnited StatesActive, not recruiting
Hunterdon Hematology Oncology
Coordinator of this site? Confirm its status
FlemingtonUnited StatesCompleted
The Oncology Institute of Hope and Innovation 1
Coordinator of this site? Confirm its status
Fort LauderdaleUnited StatesActive, not recruiting
Florida Cancer Specialists
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Fort MyersUnited StatesActive, not recruiting
Fort Wayne Medical Oncology and Hematology
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Fort WayneUnited StatesActive, not recruiting
JPS Health Network
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Fort WorthUnited StatesCompleted
Univ of Florida
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GainesvilleUnited StatesActive, not recruiting
Los Angeles Cancer Network
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GlendaleUnited StatesActive, not recruiting
Glendale Adventist Medical Center
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GlendaleUnited StatesCompleted
Oncology Physicians Network Healthcare
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GlendaleUnited StatesCompleted
Lutheran Hospital - Cancer Centers of Colorado
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GoldenUnited StatesCompleted
City of Hope - Phoenix
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GoodyearUnited StatesActive, not recruiting
Marin Cancer Center
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GreenbraeUnited StatesCompleted
Hope and Healing Cancer Services
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HinsdaleUnited StatesCompleted
Memorial Regional Hospital
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HollywoodUnited StatesRecruiting
Oncology Consultants Texas
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HoustonUnited StatesActive, not recruiting
MD Anderson Cancer Center
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HoustonUnited StatesActive, not recruiting
City of Hope Seacliff
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Huntington BeachUnited StatesActive, not recruiting
Clearview Cancer Institute
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HuntsvilleUnited StatesCompleted
City of Hope Orange County Lennar Foundation Cancer Center
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IrvineUnited StatesActive, not recruiting
Jackson Oncology Associates
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JacksonUnited StatesCompleted
Mayo Clinic
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JacksonvilleUnited StatesActive, not recruiting
Baptist MD Anderson Cancer Center
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JacksonvilleUnited StatesActive, not recruiting
Truman Medical Ctr West
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Kansas CityUnited StatesRecruiting
Tennessee Cancer Specialists
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KnoxvilleUnited StatesActive, not recruiting
University of Tennessee
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KnoxvilleUnited StatesActive, not recruiting
University of California San Diego Health
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La JollaUnited StatesActive, not recruiting
City of Hope Antelope Valley
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LancasterUnited StatesRecruiting
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesActive, not recruiting
Rocky Mountain Cancer Centers
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Lone TreeUnited StatesActive, not recruiting
City of Hope Long Beach Elm
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Long BeachUnited StatesRecruiting
Cancer and Blood Specialty Clinic
Coordinator of this site? Confirm its status
Los AlamitosUnited StatesActive, not recruiting
Cedars-Sinai Medical Center
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Los AngelesUnited StatesActive, not recruiting
USC / Norris Comprehensive Cancer Center
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Los AngelesUnited StatesActive, not recruiting
Valkyrie Clinical Trials
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Los AngelesUnited StatesActive, not recruiting
Baptist Cancer Center
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MemphisUnited StatesCompleted
Baptist Health Miami Cancer Institute
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MiamiUnited StatesActive, not recruiting
Sylvester Comprehensive Cancer Center*
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MiamiUnited StatesCompleted
Laura & Isaac Perlmutter Cancer Center at NYU Langone Hospital - Long Island
Coordinator of this site? Confirm its status
MineolaUnited StatesActive, not recruiting
University of Minnesota
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MinneapolisUnited StatesCompleted
Providence Medical Foundation
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Mission ViejoUnited StatesActive, not recruiting
Morristown Medical Center
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MorristownUnited StatesActive, not recruiting
Valkyrie Clinical Trials Murrieta
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MurrietaUnited StatesActive, not recruiting
Tennessee Oncology
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NashvilleUnited StatesActive, not recruiting
SCRI Oncology Partners
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NashvilleUnited StatesRecruiting
ChristianaCare Helen F Graham Cancer Center and Research Institute
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NewarkUnited StatesActive, not recruiting
Rutgers Cancer Institute of New Jersey
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New BrunswickUnited StatesActive, not recruiting
Yale - New Haven Hospital - Yale Cancer Center
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New HavenUnited StatesActive, not recruiting
City of Hope Cancer Center
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NewnanUnited StatesActive, not recruiting
Herbert Irving Comprehensive Cancer Center Columbia University Medical Center
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New YorkUnited StatesCompleted
NYU Langone Health Laura and Isaac Perlmutter Cancer Center
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New YorkUnited StatesActive, not recruiting
Illinois Cancer Specialists
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NilesUnited StatesCompleted
Investigative Clinical Research of Indiana, LLC
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NoblesvilleUnited StatesActive, not recruiting
Kaiser Permanente Oakland Medical Center
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OaklandUnited StatesCompleted
Texas Oncology Odessa-West Texas Cancer Center
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OdessaUnited StatesCompleted
Vista Oncology
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OlympiaUnited StatesActive, not recruiting
St. Joseph Hospital Center for Cancer Prevention and Treatment
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OrangeUnited StatesCompleted
University of California Irvine
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OrangeUnited StatesActive, not recruiting
AdventHealth Orlando
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OrlandoUnited StatesActive, not recruiting
Orlando Health Cancer Institute
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OrlandoUnited StatesActive, not recruiting
Sutter Health Palo Alto Medical Foundation
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Palo AltoUnited StatesCompleted
Lankenau Institute for Medical Research Main Line Health Paoli Hospital
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PaoliUnited StatesCompleted
Memorial Cancer Institute
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Pembroke PinesUnited StatesRecruiting
Illinois CancerCare
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PeoriaUnited StatesActive, not recruiting
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesActive, not recruiting
Jefferson Health Northeast
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PhiladelphiaUnited StatesCompleted
Philadelphia VA Medical Center
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PhiladelphiaUnited StatesCompleted
Oregon Health and Science University
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PortlandUnited StatesActive, not recruiting
Mayo Clinic - Rochester
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RochesterUnited StatesActive, not recruiting
Kaiser Permanente Roseville Medical Center
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RosevilleUnited StatesCompleted
Sutter Institute for Medical Research
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SacramentoUnited StatesCompleted
UC Davis Comprehensive Cancer Center
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SacramentoUnited StatesActive, not recruiting
Huntsman Cancer Institute
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Salt Lake CityUnited StatesActive, not recruiting
Texas Oncology San Antonio Northeast
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San AntonioUnited StatesActive, not recruiting
UCSF Zuckerberg San Francisco General Hospital
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San FranciscoUnited StatesActive, not recruiting
Kaiser Permanente San Francisco Medical Center
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San FranciscoUnited StatesCompleted
California Pacific Medical Center
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San FranciscoUnited StatesCompleted
Sansum Clinic
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Santa BarbaraUnited StatesActive, not recruiting
Kaiser Permanente Santa Clara Medical Center
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Santa ClaraUnited StatesActive, not recruiting
Providence Medical Foundation 1
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Santa RosaUnited StatesActive, not recruiting
Ellis Hospital
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SchenectadyUnited StatesActive, not recruiting
New York Cancer and Blood Specialists
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ShirleyUnited StatesActive, not recruiting
Maryland Oncology Hematology P.A.
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Silver SpringUnited StatesActive, not recruiting
Avera Medical Group
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Sioux FallsUnited StatesCompleted
City of Hope South Pasadena
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South PasadenaUnited StatesRecruiting
Summit Cancer Centers
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SpokaneUnited StatesActive, not recruiting
Community Clinical Trials
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SpringUnited StatesCompleted
Oncology Hematology Associates
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SpringfieldUnited StatesCompleted
Washington University School of Medicine
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St LouisUnited StatesActive, not recruiting
Florida Cancer Specialists & Research Institute 1
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St. PetersburgUnited StatesActive, not recruiting
Overlook Medical Center
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SummitUnited StatesRecruiting
Moffitt Cancer Center
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TampaUnited StatesActive, not recruiting
Holy Name Medical Center
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TeaneckUnited StatesCompleted
Montefiore Medical Center
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The BronxUnited StatesActive, not recruiting
Renovatio Clinical 1
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The WoodlandsUnited StatesCompleted
Texas Oncology - Northeast
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TylerUnited StatesActive, not recruiting
The University of Texas Health Science Center at Tyler
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TylerUnited StatesActive, not recruiting
City of Hope Upland
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UplandUnited StatesRecruiting
Kaiser Permanente Northern California
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VallejoUnited StatesActive, not recruiting
Northwest Cancer Specialists - Vancouver
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VancouverUnited StatesCompleted
Kaiser Permanente Walnut Creek Medical Center
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Walnut CreekUnited StatesActive, not recruiting
John Muir Health Clinical Research Center
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Walnut CreekUnited StatesActive, not recruiting
Washington DC VA Medical Center
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Washington D.C.United StatesCompleted
MedStar Georgetown University Hospital
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Washington D.C.United StatesActive, not recruiting
Texas Oncology - Gulf Coast
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WebsterUnited StatesCompleted
Clinical Research Alliance Inc
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WestburyUnited StatesCompleted
Florida Cancer Specialists & Research Institute
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West Palm BeachUnited StatesActive, not recruiting
McGlinn Cancer Institute Reading Hospital
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West ReadingUnited StatesActive, not recruiting
Regional Medical Oncology Center
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WilsonUnited StatesActive, not recruiting
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
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Winston-SalemUnited StatesCompleted
Lankenau Institute for Medical Research
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WynnewoodUnited StatesCompleted
Trinity Health St Joseph Mercy Ann Arbor
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YpsilantiUnited StatesActive, not recruiting
City of Hope - Chicago
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ZionUnited StatesRecruiting

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