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NCT04538664Active, not recruitingPhase 3

A Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Participants With Advanced or Metastatic Non-Small Cell Lung Cancer Characterized by Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions

61186372NSC3001: A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared With Carboplatin-Pemetrexed, in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Source: ClinicalTrials.gov · Last updated 3 Nov 2026

Brief summary (registry, in English)

The purpose of this study is to compare the efficacy, as demonstrated by progression-free survival (PFS), in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) characterized by EGFR Exon 20ins mutations.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
308 (actual)
First submitted
31 Aug 2020
Start date
13 Oct 2020
Primary completion date
3 May 2023
Lead sponsor
Janssen Research & Development, LLC
Diseases
Lung cancer
NCT number
NCT04538664
EU CT number
2023-506033-29-00
EudraCT number
2020-000633-40

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 308
  • From 13 Oct 2020 to the primary completion date, 3 May 2023
  • 189 sites in 26 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 untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior to randomization is eligible)

Other illness

  • Participant has evidence of synchronous NSCLC disease (as suggested by genetic characterization or radiographic appearance)
  • Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation
  • Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD, or radiation pneumonitis
  • Participant has a contraindication to the use of carboplatin or pemetrexed (refer to local prescribing information for each agent). Participant has a history of hypersensitivity to, or cannot take, vitamin B12 or folic acid

Who the study is looking for

  • Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (NSCLC) with documented primary epidermal growth factor receptor (EGFR) Exon 20ins activating mutation
  • Participant must have measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream
  • A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study

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

Full criteria on ClinicalTrials.gov

Sites (189)

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

SiteCityCountrySite status
Chris O'Brien Lifehouse
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CamperdownAustraliaUnknown status
St George Hospital
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KogarahAustraliaUnknown status
Cabrini Medical Centre
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MalvernAustraliaUnknown status
Sir Charles Gairdner Hospital
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NedlandsAustraliaUnknown status
UZ Leuven
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LeuvenBelgiumCompleted
UCL Mont-Godinne
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YvoirBelgiumCompleted
Fundacao Pio XII
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BarretosBrazilUnknown status
Cetus Oncologia
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Belo HorizonteBrazilUnknown status
Ynova Pesquisa Clinica
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FlorianópolisBrazilUnknown status
Oncosite - Centro de Pesquisa Clínica em Oncologia Ltda
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IjuíBrazilUnknown status
Liga Norte Riograndense Contra o Cancer
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NatalBrazilUnknown status
UPCO Unidade de Pesquisa Clinica em Oncologia
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PelotasBrazilUnknown status
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
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Porto AlegreBrazilUnknown status
Irmandade Santa Casa de Misericordia de Porto Alegre
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Porto AlegreBrazilUnknown status
Instituto D Or de Pesquisa e Ensino IDOR
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Rio de JaneiroBrazilUnknown status
Oncoclinicas Rio de Janeiro S A
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Rio de JaneiroBrazilUnknown status
Ministerio da Saude Instituto Nacional do Cancer
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Rio de JaneiroBrazilUnknown status
Fundacao Antonio Prudente A C Camargo Cancer Center
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São PauloBrazilUnknown status
Núcleo de Pesquisa São Camilo
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São PauloBrazilUnknown status
Fundacao Faculdade de Medicina Instituto do Cancer do Estado de Sao Paulo
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São PauloBrazilUnknown status
IOS - Instituto de Oncologia de Sorocaba Dr. Gilson Delgado
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SorocabaBrazilUnknown status
Hospital Evangélico de Cachoeiro de Itapemirim
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VitóriaBrazilUnknown status
McGill University Health Centre
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MontrealCanadaUnknown status
The Ottawa Hospital Cancer Centre
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OttawaCanadaUnknown status
Sunnybrook Health Sciences Centre
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TorontoCanadaUnknown status
Beijing Cancer Hospital
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BeijingChinaUnknown status
Chinese PLA General Hospital
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BeijingChinaUnknown status
Beijing chest hospital, Capital Medical University
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BeijingChinaUnknown status
Beijing Cancer Hospital Chest Tumor Internal Medicine dept. II
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BeijingChinaUnknown status
Peking University International Hospital
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BeijingChinaUnknown status
Jilin Cancer Hospital
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ChangchunChinaUnknown status
Hunan Cancer Hospital
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ChangshaChinaUnknown status
Hunan Cancer Hospital Chest Tumor Internal Medicine dept. II
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ChangshaChinaUnknown status
The First People's Hospital Of Changzhou
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ChangzhouChinaUnknown status
West China Hospital,Sichuan University
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ChengduChinaUnknown status
Chongqing University Cancer Hospital
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ChongqingChinaUnknown status
Fujian Medical University Union Hospital
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FuzhouChinaUnknown status
The First Affiliated Hospital, Sun Yat-sen University
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GuangzhouChinaUnknown status
The First Affiliated Hospital Zhejiang University College of Medicine
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HangzhouChinaUnknown status
The Second Affiliated Hospital of Zhejiang University College of Medicine 1
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HangzhouChinaUnknown status
Zhejiang Cancer Hospital
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HangzhouChinaUnknown status
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
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HangzhouChinaUnknown status
The Second Affiliated Hospital of Zhejiang University College of Medicine
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HangzhouChinaUnknown status
Harbin Medical University Cancer Hospital
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HarbinChinaUnknown status
Taizhou Hospital of Zhejiang Province
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LinhaiChinaUnknown status
Nanjing Drum Tower hospital
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NanjingChinaUnknown status
Shanghai Chest Hospital
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ShanghaiChinaUnknown status
Fudan University Shanghai Cancer Center
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ShanghaiChinaUnknown status
Shanghai Pulmonary Hospital
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ShanghaiChinaUnknown status
Shanghai East Hospital
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ShanghaiChinaUnknown status
Shengjing Hospital Of China Medical University
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ShenyangChinaUnknown status
Cancer Hospital Chinese Academy Of Medical Sciences, Shenzhen Center
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ShenzhenChinaUnknown status
Tianjin Medical University General Hospital
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TianjinChinaUnknown status
Weifang People's Hospital
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WeifangChinaUnknown status
TongJi Hospital of TongJi Medical College of Huazhong University of Science & Technology
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WuhanChinaUnknown status
Hospital of Jiangnan University
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WuxiChinaUnknown status
The First Affiliated Hospital of Xian Jiaotong University
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Xi'anChinaUnknown status
Yantai Yuhuangding Hospital
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YantaiChinaUnknown status
Henan Cancer Hospital
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ZhengzhouChinaUnknown status
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyCompleted
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital Universitario Virgen de la Victoria
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MálagaSpainCompleted
University Hospital Virgen Del Rocio S.L.
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SevillaSpainCompleted
Hospices Civils de Lyon
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BronFranceCompleted
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceCompleted
Institut Curie
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ParisFranceCompleted
Centre Hospitalier Universitaire de Bordeaux
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PessacFranceCompleted
Edinburgh Cancer Centre Western General
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EdinburghUnited KingdomUnknown status
The Royal Marsden NHS Trust Chelsea
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LondonUnited KingdomUnknown status
The Royal Marsden NHS Trust Sutton
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SuttonUnited KingdomUnknown status
Koranyi National Institute For Pulmonology
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Budapest XIIHungaryCompleted
Shaare Zedek Medical Center
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JerusalemIsraelUnknown status
Hadassah medical Center
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JerusalemIsraelUnknown status
Meir Medical Center
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Kfar SabaIsraelUnknown status
Rabin Medical Center
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Petah TikvaIsraelUnknown status
Tel-Aviv Sourasky Medical Center
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Tel AvivIsraelUnknown status
Basavatarakam Indo-American Hospital
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HyderabadIndiaUnknown status
Tata Medical Center
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KolkataIndiaUnknown status
Tata Memorial Hospital
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MumbaiIndiaUnknown status
HCG Manavta Cancer Centre
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NashikIndiaUnknown status
Rajiv Gandhi Cancer Institute & Research Centre
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New DelhiIndiaUnknown status
Noble Hospital Pvt Ltd
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PuneIndiaUnknown status
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l
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MeldolaItalyActive, not recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyActive, not recruiting
Juntendo University Hospital
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Bunkyō CityJapanUnknown status
Saitama Medical University International Medical Center
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HidakaJapanUnknown status
National Hospital Organization Himeji Medical Center
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HimejiJapanUnknown status
Kansai Medical University Hospital
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HirakataJapanUnknown status
Kanazawa University Hospital
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KanazawaJapanUnknown status
National Cancer Center Hospital East
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KashiwaJapanUnknown status
Kishiwada City Hospital
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KishiwadaJapanUnknown status
Kobe City Medical Center General Hospital
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KobeJapanUnknown status
Kurashiki Central Hospital
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KurashikiJapanUnknown status
Kurume University Hospital
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KurumeJapanUnknown status
Matsusaka Municipal Hospital
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MatsusakaJapanUnknown status
Aichi Cancer Center Hospital
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NagoyaJapanUnknown status
National Hospital Organization Nagoya Medical Center
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NagoyaJapanUnknown status
Niigata Cancer Center Hospital
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NiigataJapanUnknown status
Kindai University Hospital
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Osaka Sayama ShiJapanUnknown status
Kitasato University Hospital
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SagamiharaJapanUnknown status
Hokkaido University Hospital
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SapporoJapanUnknown status
Iwate Medical University Hospital
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Shiwa-gunJapanUnknown status
Shizuoka Cancer Center
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ShizuokaJapanUnknown status
The Cancer Institute Hospital of JFCR
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TokyoJapanUnknown status
Ehime University Hospital
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Toon-shiJapanUnknown status
Wakayama Medical University Hospital
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WakayamaJapanUnknown status
National Hospital Organization Yamaguchi Ube Medical Center
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YamaguchiJapanUnknown status
Inje University Haeundae Paik Hospital
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BusanSouth KoreaUnknown status
National Cancer Center 1
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Gyeonggi-doSouth KoreaUnknown status
Gyeongsang National University Hospital
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Gyeongsangnam-doSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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Jeollanam-doSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
Korea University Anam Hospital
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
Centro Oncologico de Chihuahua
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Chihuahua CityMexicoUnknown status
Hospital Civil de Guadalajara Fray Antonio Alcalde
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GuadalajaraMexicoUnknown status
Health Pharma Professional Research
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MéxicoMexicoUnknown status
Mexico Centre for Clinical Research S.A de C.V
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Mexico CityMexicoUnknown status
Instituto Nacional de Cancerologia
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Mexico CityMexicoUnknown status
Médica Sur
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Mexico CityMexicoUnknown status
i Can Oncology Center
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MonterreyMexicoUnknown status
Oncologia Integral Satelite
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NaucalpanMexicoUnknown status
Hospital Pulau Pinang
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George TownMalaysiaUnknown status
Hospital Sultan Ismail
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Johor BahruMalaysiaUnknown status
University Malaya Medical Centre
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Kuala LumpurMalaysiaUnknown status
Hospital Kuala Lumpur
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Kuala LumpurMalaysiaUnknown status
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandActive, not recruiting
Uniwersyteckie Centrum Kliniczne
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GdanskPolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Pan American Center for Oncology Trials LLC
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Rio PiedrasPuerto RicoUnknown status
Hospital Cuf Descobertas S.A.
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LisbonPortugalActive, not recruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.
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PortoPortugalActive, not recruiting
Irkutsk Regional Oncology Dispensary
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IrkutskRussiaUnknown status
Moscow City Oncology Hospital No 62
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KrasnogorskRussiaUnknown status
Krasnoyarsk Regional Oncology Dispensary
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KrasnoyarskRussiaUnknown status
Leningrad Regional Oncology Dispensary
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KuzmolovskyRussiaUnknown status
MCK
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MoscowRussiaUnknown status
City Clinical Hospital #1
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Nal'chikRussiaUnknown status
Nizhny Novgorod Regional Oncological Dispensary
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Nizhny NovgorodRussiaUnknown status
N.N. Petrov Research Institute Of Oncology
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Saint PetersburgRussiaUnknown status
Leningrad regional clinical hospital
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Saint PetersburgRussiaUnknown status
Oncology Medical Clinics AV Medical group
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Saint PetersburgRussiaUnknown status
Tomsk Cancer Research Institute
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TomskRussiaUnknown status
Bashkir State Medical University
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UfaRussiaUnknown status
Yaroslavl Regional Clinical Oncology Hospital
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YaroslavlRussiaUnknown status
Phramongkutklao Hospital and Medical College
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BangkokThailandUnknown status
Siriraj Hospital
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BangkokThailandUnknown status
Songklanagarind Hospital, Prince of Songkla University
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SongkhlaThailandUnknown status
Chang Gung Medical Foundation
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Taipei Medical University Shuang Ho Hospital
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New Taipei CityTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
Chung Shan Medical University Hospital
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TaichungTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Dnipropetrovsk State Medical Academy, Dnipropetrovsk City Multifield Clinical Hospital # 4
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DniproUkraineUnknown status
Medical Center 'Ok Clinic' of LLC 'International Institute of Clinical Studies'
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KyivUkraineUnknown status
National Cancer Institute
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KyivUkraineUnknown status
University Cancer And Blood Center LLC
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AthensUnited StatesUnknown status
Henry Ford Hospital
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DetroitUnited StatesUnknown status
City of Hope 2
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DuarteUnited StatesUnknown status
Regional Cancer Care Associates LLC
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East BrunswickUnited StatesUnknown status
Virginia Cancer Specialists
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FairfaxUnited StatesUnknown status
Langone Health at NYC University, NYU School of Medicine
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New YorkUnited StatesUnknown status
Columbia University Medical Center
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New YorkUnited StatesUnknown status
University of California Irvine
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OrangeUnited StatesUnknown status
Providence Portland Medical Center
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PortlandUnited StatesUnknown status
Blue Ridge Cancer Care
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SalemUnited StatesUnknown status
Utah Cancer Specialists
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Salt Lake CityUnited StatesUnknown status
UCLA
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Santa MonicaUnited StatesUnknown status
Sanford Health
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Sioux FallsUnited StatesUnknown status
Washington University Medical Center
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St LouisUnited StatesUnknown status
H. Lee Moffitt Cancer & Research Institute
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TampaUnited StatesUnknown status
Texas Oncology Pa
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TylerUnited StatesUnknown status
Georgetown University Hospital
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Washington D.C.United StatesUnknown status
Başkent University Medical Faculty Adana Application and Research Center
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AdanaTurkey (Türkiye)Unknown status
Adana City Hospital
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AdanaTurkey (Türkiye)Unknown status
Gazi University Hospital
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AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent City Hospital
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AnkaraTurkey (Türkiye)Unknown status
Trakya University Medical Faculty
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EdirneTurkey (Türkiye)Unknown status
Medipol Mega University Hospital
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IstanbulTurkey (Türkiye)Unknown status
Istanbul Universitesi Cerrahpasa Tip Fakultesi Ic Hastaliklari Anabilim Dali Medikal Onkoloji Bd
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IstanbulTurkey (Türkiye)Unknown status
Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
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IstanbulTurkey (Türkiye)Unknown status
Izmir Medical Park Hospital
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IzmirTurkey (Türkiye)Unknown status

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