Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)

Last updated: April 16, 2025
Sponsor: Amgen
Overall Status: Active - Recruiting

Phase

3

Condition

Small Cell Lung Cancer

Treatment

Placebo

Tarlatamab

Clinical Study ID

NCT06117774
20230016
2023-506235-15
  • Ages > 18
  • All Genders

Study Summary

The primary objective of this study is to compare the efficacy of tarlatamab with placebo as assessed by progression free survival (PFS).

Eligibility Criteria

Inclusion

Inclusion Criteria: -Participants are eligible to be included in the study only if all of the following criteria apply:

  • Participant has provided informed consent prior to initiation of any study specificactivities/procedures.

  • Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).

  • Histologically or cytologically confirmed small-cell lung cancer (SCLC).

  • Diagnosed and treated for LS-SCLC with concurrent chemotherapy and radiotherapy.

  • Has completed chemoradiotherapy without progression per Response Evaluation Criteriain Solid Tumors v1.1 (RECIST 1.1.) (ie, achieved complete response [CR], partialresponse [PR], or stable disease [SD]).

  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1.

  • Minimum life expectancy of 12 weeks.

  • Adequate organ function.

  • Toxicities attributed to concurrent chemoradiotherapy resolved to grade ≤ 1, unlessotherwise specified. Excluding alopecia or fatigue.

Exclusion

Exclusion Criteria: -Participants are excluded from the study if any of the following criteria apply:

Disease Related

  • Extensive-stage SCLC (ES-SCLC).

  • Any previous diagnosis of transformed non-small-cell lung cancer (NSCLC), epidermalgrowth factor receptor (EGFR) activating mutation positive NSCLC that hastransformed to SCLC, or mixed SCLC NSCLC histology.

  • Evidence of interstitial lung disease or active, non-infectious pneumonitis. OtherMedical Conditions

  • History of other malignancy within the past 2 years, with certain exceptions.

  • History of solid organ transplantation.

  • Myocardial infarction and/or symptomatic congestive heart failure (New York HeartAssociation > class II) within 6 months prior to first dose of study treatment.

  • History of arterial thrombosis (eg, stroke or transient ischemic attack) within 6months prior to first dose of study treatment.

  • Exclusion of human immunodeficiency virus (HIV) and/or hepatitis infection based oncriteria per protocol.

  • Participant with symptoms and/or clinical signs and/or radiographic signs thatindicate an acute and/or uncontrolled active systemic infection within 7 days priorto the first dose of study treatment.

Prior/Concomitant Therapy

  • Received sequential chemotherapy and thoracic radiotherapy (no overlap of thoracicradiotherapy with chemotherapy) during chemoradiation.

  • Prior therapy with any selective inhibitor of the delta-like ligand 3 (DLL3)pathway.

  • Prior history of severe or life-threatening events from any immune-mediated therapy.

  • Receiving another anti-cancer therapy. Adjuvant hormonal therapy for resected breastcancer is permitted.

  • Receiving systemic corticosteroid therapy or any other form of immunosuppressivetherapy within 7 days prior to enrollment.

  • Major surgical procedures within 28 days prior to first dose of study treatment.

  • Treatment with live virus, including live-attenuated vaccination, within 14 daysprior to the first dose of study treatment. Inactive vaccines and live viralnon-replicating vaccines within 3 days prior to first dose of study treatment.

Prior/Concurrent Clinical Study Experience

• Treatment in an alternative investigational trial within 28 days prior to enrollment.

Other Exclusions

  • Female participants of childbearing potential unwilling to use protocol specifiedmethod of contraception during treatment and for an additional 60 days after thelast dose of study treatment.

  • Female participants who are breastfeeding or who plan to breastfeed while on studythrough 60 days after the last dose of study treatment.

  • Female participants planning to become pregnant or donate eggs while on studythrough 60 days after the last dose of study treatment.

  • Female participants of childbearing potential with a positive pregnancy testassessed at screening by a highly sensitive serum pregnancy test.

  • Male participants with a female partner of childbearing potential who are unwillingto practice sexual abstinence (refrain from heterosexual intercourse) or usecontraception during treatment and for an additional 60 days after the last dose ofstudy treatment.

  • Male participants with a pregnant partner who are unwilling to practice abstinenceor use a condom during treatment and for an additional 60 days after the last doseof study treatment.

  • Male participants unwilling to abstain from donating sperm during treatment and foran additional 60 days after the last dose of study treatment.

  • Participant has known sensitivity to any of the products or components to beadministered during dosing.

  • Participant likely to not be available to complete all protocol-required studyvisits or procedures, and/or to comply with all required study procedures to thebest of the participant and investigator's knowledge.

  • History or evidence of any other clinically significant disorder, condition, ordisease (with the exception of those outlined above) that, in the opinion of theinvestigator or Amgen physician, if consulted, would pose a risk to participantsafety or interfere with the study evaluation, procedures or completion.

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 20, 2024
Estimated Completion Date:
October 31, 2029

Connect with a study center

  • Hospital Aleman Buenos Aires

    Ciudad Autonoma de Buenos Aires, Buenos Aires C1118AAT
    Argentina

    Site Not Available

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    La Plata, Buenos Aires 1900
    Argentina

    Active - Recruiting

  • Instituto Oncologico de Cordoba Ionc Fundacion Richardet Longo

    Cordoba, Córdoba 5003
    Argentina

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  • Hospital Aleman Buenos Aires

    Caba, Distrito Federal C1118AAT
    Argentina

    Active - Recruiting

  • Clinica Viedma

    Viedma, Río Negro R8500ACE
    Argentina

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  • Sanatorio 9 de Julio Cice 9 de Julio

    San Miguel de Tucuman, Tucuman 4000
    Argentina

    Active - Recruiting

  • Sanatorio 9 de julio - C.I.C.E. 9 de Julio

    San Miguel de Tucuman, Tucuman 4000
    Argentina

    Site Not Available

  • Fundacion Respirar

    Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • Instituto Argentino de Diagnóstico y Tratamiento

    Buenos Aires, C1122AAL
    Argentina

    Active - Recruiting

  • Chris OBrien Lifehouse

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Port Macquarie Base Hospital

    Port Macquarie, New South Wales 2444
    Australia

    Active - Recruiting

  • Westmead Hospital

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

  • Flinders Medical Centre

    Bedford Park, South Australia 5042
    Australia

    Active - Recruiting

  • Monash Medical Centre

    Clayton, Victoria 3168
    Australia

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  • Fiona Stanley Hospital

    Murdoch, Western Australia 6150
    Australia

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    Graz, 8036
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  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Wein, 1090
    Austria

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  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Wien, 1090
    Austria

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  • Institut Jules Bordet

    Anderlecht, 1070
    Belgium

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    Brussels, B-1070
    Belgium

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  • Universitair Ziekenhuis Gent

    Gent, 9000
    Belgium

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  • Universitair Ziekenhuis Leuven - Campus Gasthuisberg

    Leuven, 3000
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    Vitoria, Espírito Santo 29043-260
    Brazil

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  • Londrina Cancer Hospital

    Londrina, Paraná 86015-520
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  • Liga Norte-Riograndense Contra O Cancer

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    Porto Alegre, Rio Grande Do Sul 91350-200
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    Porto Alegre, Rio Grande Do Sul 91350-200
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    Jau, São Paulo 17210-120
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    Sao Paulo, São Paulo 01308-050
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    Rio de Janeiro, 22793-080
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  • Instituto do Cancer do Estado de Sao Paulo Octavio Frias de Oliveira Icesp

    São Paulo, 01246-000
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    Sofia, 1606
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    Sofia, 1113
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    Sofia, 1527
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    Beijing, Beijing 100142
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    Chongqing, Chongqing 400030
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    Fuzhou, Fujian 350014
    China

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    Fuzhou, Fujian 350025
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    Guangzhou, Guangdong 510060
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    Zhengzhou, Henan 450003
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    Wuhan, Hubei 430070
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    Wuhan, Hubei 430060
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    Wuhan, Hubei 430030
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    Changsha, Hunan 410013
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    Nanchang, Jiangxi 330029
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    Changchun, Jilin 130021
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    Jinan, Shandong 250117
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    Shanghai, Shanghai 200032
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    Taizhou, Zhejiang 317099
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  • Centro de Tratamiento e Investigación sobre Cancer Luis Carlos Sarmiento Angulo Ctic

    Bogota, Cundinamarca 0129
    Colombia

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  • Instituto Medico de Alta Tecnologia sas - Imat sas

    Monteria, Córdoba
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  • Oncomedica SAS

    Monteria, Córdoba
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    Pereira, Risaralda 660001
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  • Fundacion cardiovascular de Colombia

    Bucaramanga, Santander 681017
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  • Centre Hospitalier Régional Universitaire de Lille - Institut Coeur Poumon

    Lille, 59037
    France

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  • Centre Hospitalier Universitaire de Marseille - Hopital de la Timone

    Marseille, 13005
    France

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    Marseille Cedex 20, 13915
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  • Centre Hospitalier Universitaire de Nice - Hopital Pasteur

    Nice Cedex 01, 06002
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    Paris, 75018
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  • Centre Hospitalier Villefranche

    Villefranche Sur Saone Cedex, 69400
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  • Hopital Nord Ouest Villefranche sur Saone

    Villefranche Sur Saone Cedex, 69400
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    Essen, 45147
    Germany

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    Essen, 45147
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  • Universitaetsmedizin Goettingen

    Goettingen, 37075
    Germany

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    Göttingen, 37075
    Germany

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    Heidelberg, 69126
    Germany

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    Wuerzburg, 97078
    Germany

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  • Agios Savvas Anticancer Hospital

    Athens, 11522
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  • Henry Dunant Hospital Center

    Athens, 11526
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    Athens, 18547
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  • Sotiria General Hospital

    Athens, 11527
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  • European Interbalkan Medical Center

    Thessaloniki, 57001
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  • Saint Lukes Hospital SA

    Thessaloniki, 55236
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    Hong Kong,
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  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong,
    Hong Kong

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  • University of Hong Kong, Queen Mary Hospital

    Hong Kong,
    Hong Kong

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  • Princess Margaret Hospital

    Kowloon,
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    Shatin,
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    Shatin, New Territories,
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  • Prince of Wales Hospital

    Shatin, New Territories,
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    Shatin, New Territories,
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  • Prince of Wales Hospital, Chinese University of Hong Kong

    Shatin, New Territories,
    Hong Kong

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  • Rambam Medical Center

    Haifa, 3109601
    Israel

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  • Centro di Riferimento Oncologico di Aviano

    Aviano PN, 33081
    Italy

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  • IRCCS Istituto Clinico Humanitas

    Milan, 20089
    Italy

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  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milano, 20133
    Italy

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  • IRCCS Istituto Oncologico Europeo

    Milano, 20141
    Italy

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  • Istituto Oncologico Europeo

    Milano, 20141
    Italy

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  • Azienda Ospedaliera Universitaria San Luigi Gonzaga

    Orbassano, 10043
    Italy

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  • Istituto Oncologico Veneto IRCCS

    Padova, 35128
    Italy

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  • Azienda Ospedaliera di Perugia Ospedale Santa Maria della Misericordia

    Perugia, 06156
    Italy

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  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56124
    Italy

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    Pisa, 56126
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    Reggio Emilia, 42123
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  • Policlinico Universitario Agostino Gemelli

    Rome, 00168
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    Statte, 74010
    Italy

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  • National Hospital Organization Nagoya Medical Center

    Nagoya-shi, Aichi 460-0001
    Japan

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  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba 277-8577
    Japan

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  • National Hospital Organization Shikoku Cancer Center

    Matsuyama-shi, Ehime 791-0280
    Japan

    Active - Recruiting

  • Kurume University Hospital

    Kurume-shi, Fukuoka 830-0011
    Japan

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  • National Hospital Organization Hokkaido Cancer Center

    Sapporo-shi, Hokkaido 003-0804
    Japan

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  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    Yokohama-shi, Kanagawa 241-8515
    Japan

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  • Sendai Kousei Hospital

    Sendai-shi, Miyagi 981-0914
    Japan

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  • Niigata Cancer Center Hospital

    Niigata-shi, Niigata 951-8566
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  • Okayama University Hospital

    Okayama-shi, Okayama 700-8558
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  • Kansai Medical University Hospital

    Hirakata-shi, Osaka 573-1191
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  • Osaka International Cancer Institute

    Osaka-shi, Osaka 541-8567
    Japan

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  • Kindai University Hospital

    Osakasayama-shi, Osaka 589-8511
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    Hidaka-Shi, Saitama 350-1298
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    Kitaadachi-gun, Saitama 362-0806
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  • Shizuoka Cancer Center

    Nagaizumi, Shizuoka 411-8777
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    Sunto-gun, Shizuoka 411-8777
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  • Dokkyo Medical University Hospital

    Mibu, Tochigi 321-0293
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    Shimotsuga-gun, Tochigi 321-0293
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    Bunkyo-ku, Tokyo 113-8431
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    Koto-ku, Tokyo 135-8550
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    Bystra, 43-360
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    Lublin, 20-954
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    Lublin, 20-090
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    Poznan, 60-569
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    Prabuty, 82-550
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    Warsaw, 02-781
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    Warszawa, 02-781
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    Bucharest, 011461
    Romania

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    Bucuresti, 022328
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    Cluj Napoca, 400015
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    Craiova, 200542
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    Active - Recruiting

  • Institutul Regional de Oncologie Iasi

    Iasi, 700483
    Romania

    Active - Recruiting

  • Spitalul Municipal Ploiesti

    Ploiesti, 100337
    Romania

    Active - Recruiting

  • SC Oncomed SRL

    Timisoara, 300239
    Romania

    Active - Recruiting

  • Icon - Mount Alvernia

    Singapore, 217562
    Singapore

    Active - Recruiting

  • Icon Cancer Centre Singapore - Farrer Park

    Singapore, 217562
    Singapore

    Site Not Available

  • National Cancer Centre Singapore

    Singapore, 168583
    Singapore

    Active - Recruiting

  • Hospital Regional Universitario de Malaga

    Malaga, Andalucía 29011
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla, Andalucía 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, Canarias 35016
    Spain

    Active - Recruiting

  • Hospital Universitari Germans Trias i Pujol

    Badalona, Cataluña 08916
    Spain

    Site Not Available

  • Institut Catala d Oncologia Badalona Hospital Universitari Germans Trias i Pujol

    Badalona, Cataluña 08916
    Spain

    Active - Recruiting

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, Cataluña 08036
    Spain

    Active - Recruiting

  • Hospital Universitari Vall d Hebron

    Barcelona, Cataluña 08035
    Spain

    Active - Recruiting

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Cataluña 08041
    Spain

    Active - Recruiting

  • Hospital del Mar

    Barcelona, Cataluña 08003
    Spain

    Active - Recruiting

  • Instituto Valenciano de Oncologia

    Valencia, Comunidad Valenciana 46009
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, Galicia 15706
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid 28222
    Spain

    Active - Recruiting

  • Clinica Universidad de Navarra

    Pamplona, Navarra 31008
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre

    Madrid, 28041
    Spain

    Active - Recruiting

  • Sahlgrenska Universitetssjukhuset

    Goteborg, 413 45
    Sweden

    Active - Recruiting

  • Sahlgrenska Universitetssjukhuset

    Göteborg, 41346
    Sweden

    Site Not Available

  • Norrlands Universitetssjukhus

    Umea, 901 85
    Sweden

    Active - Recruiting

  • Kantonsspital Baden

    Baden, 5404
    Switzerland

    Active - Recruiting

  • Universitaetsspital Basel

    Basel, 4052
    Switzerland

    Terminated

  • Ospedale Regionale di Bellinzona e Vali

    Bellinzona, 6500
    Switzerland

    Site Not Available

  • Inselspital Bern

    Bern, 3010
    Switzerland

    Site Not Available

  • Ospedale Regionale di Bellinzona e Vali

    Mendrisio, 6850
    Switzerland

    Terminated

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 80756
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Memorial Ankara Hastanesi

    Ankara, 06520
    Turkey

    Active - Recruiting

  • Ankara Bilkent Sehir Hastanesi

    Istanbul, 34485
    Turkey

    Site Not Available

  • Bagcilar Medipol Mega Universite Hastanesi

    Istanbul, 34214
    Turkey

    Active - Recruiting

  • Izmir Medical Point Hastanesi

    Istanbul, 34485
    Turkey

    Site Not Available

  • Kocaeli Universitesi Arastirma ve Uygulama Hastanesi

    Istanbul, 34485
    Turkey

    Site Not Available

  • Marmara Universitesi Pendik Egitim Arastirma Hastanesi

    Istanbul, 34485
    Turkey

    Site Not Available

  • Marmara Universitesi Tip Fakultesi Hastanesi

    Istanbul, 34890
    Turkey

    Active - Recruiting

  • Medical Park Adana Hastanesi

    Istanbul, 34485
    Turkey

    Site Not Available

  • Medipol Mega Universite Hastanesi

    Istanbul, 34485
    Turkey

    Site Not Available

  • Izmir Ekonomi Universitesi Medical Point Hastanesi

    Izmir, 35575
    Turkey

    Active - Recruiting

  • Kocaeli Universitesi Tip Fakultesi Hastanesi

    Kocaeli, 41380
    Turkey

    Active - Recruiting

  • Medical Park Seyhan Hastanesi

    Mersin, 33200
    Turkey

    Active - Recruiting

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

    Samsun, 55200
    Turkey

    Active - Recruiting

  • Guys Hospital

    London, SE1 9RT
    United Kingdom

    Active - Recruiting

  • Christie Hospital

    Manchester, M20 4BX
    United Kingdom

    Active - Recruiting

  • Valkyrie Clinical Trials

    Los Angeles, California 90067
    United States

    Active - Recruiting

  • University of California Los Angeles

    Santa Monica, California 90404
    United States

    Active - Recruiting

  • Yale New Haven Hospital

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Boca Raton Clinical Research Global South Florida

    Plantation, Florida 33322
    United States

    Active - Recruiting

  • University of Louisville James Graham Brown Cancer Center

    Louisville, Kentucky 40202
    United States

    Active - Recruiting

  • Our Lady of the Lake Cancer Institute

    Baton Rouge, Louisiana 70808
    United States

    Active - Recruiting

  • Allina Health System dba Virginia Piper Cancer Institute

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Montefiore Einstein Center for Cancer Care

    Bronx, New York 10461
    United States

    Terminated

  • Laura and Isaac Perlmutter Cancer Center at New York University Langone

    New York, New York 10016
    United States

    Active - Recruiting

  • New York University Grossman School of Medicine and New York University Langone Hospitals

    New York, New York 10016
    United States

    Completed

  • Perlmutter Cancer Center at New York University Langone Hospital - Long Island

    New York, New York 10016
    United States

    Completed

  • FirstHealth Cancer Center

    Pinehurst, North Carolina 28374
    United States

    Active - Recruiting

  • FirstHealth Outpatient Cancer Center

    Pinehurst, North Carolina 28374
    United States

    Site Not Available

  • Lehigh Valley Health Network

    Allentown, Pennsylvania 18103
    United States

    Active - Recruiting

  • Spokenword Clinical Trials

    Easton, Pennsylvania 18045
    United States

    Active - Recruiting

  • Renovatio Clinical

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

  • US Oncology Research Investigational Products Center

    The Woodlands, Texas 77380
    United States

    Active - Recruiting

  • University of Virginia Health System

    Charlottesville, Virginia 22908
    United States

    Terminated

  • Virginia Cancer Specialists, PC

    Fairfax, Virginia 22031
    United States

    Active - Recruiting

  • West Virginia University Health Sciences Center

    Morgantown, West Virginia 26506
    United States

    Terminated

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