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NCT04475939CompletedPhase 3

Placebo-controlled Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants With Advanced/Metastatic Non-Small Cell Lung Cancer

A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Comparing Niraparib Plus Pembrolizumab Versus Placebo Plus Pembrolizumab as Maintenance Therapy in Participants Whose Disease Has Remained Stable or Responded to First-Line Platinum -Based Chemotherapy With Pembrolizumab for Stage IIIB/IIIC or IV Non-Small Cell Lung Cancer (ZEAL-1L)

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

This is a multicenter, randomized, double-blind, placebo-controlled study of niraparib plus pembrolizumab versus placebo plus pembrolizumab as maintenance therapy in participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have achieved stable disease (SD), partial response (PR), or complete response (CR) following completion of standard of care first-line (SoC 1L) platinum-based induction chemotherapy with pembrolizumab. The primary hypotheses are: participants with confirmed diagnosis of NSCLC could benefit from niraparib plus pembrolizumab versus placebo plus pembrolizumab with respect to Progression-free survival (PFS) and Overall survival (OS).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
666 (actual)
First submitted
14 Jul 2020
Start date
26 Oct 2020
Primary completion date
26 Feb 2025
Lead sponsor
GlaxoSmithKline
Diseases
Lung cancer
NCT number
NCT04475939
EU CT number
2023-508443-40-00
EudraCT number
2020-002202-20

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 666
  • From 26 Oct 2020 to the primary completion date, 26 Feb 2025
  • 164 sites in 27 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

  • Has received prior Poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor(s) in prior lines of treatment.
  • Has received colony-stimulating factors (granulocyte macrophage colony-stimulating factor or recombinant erythropoietin) within 4 weeks prior to the first dose of study treatment.
  • Has an active or previously documented autoimmune or inflammatory disorder.
  • Is receiving chronic systemic steroids (prednisone \>20 mg per day) other than intermittent use of bronchodilators, inhaled steroids, or local steroid.
  • Has other active concomitant malignancy that warrants systemic, biologic, or hormonal therapy.
  • Is pregnant, breastfeeding, or expecting to conceive children while receiving study treatment and/or for up to 180 days after the last dose of study treatment.

Other illness

  • Has mixed small cell lung cancer or sarcomatoid variant NSCLC.
  • Has any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels.
  • Has leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiographic signs of CNS hemorrhage.
  • Has a known history of Myelodysplastic syndrome (MDS) or Acute myeloid leukemia (AML).
  • Has a known history of active tuberculosis.
  • Has current active pneumonitis within 90 days of planned start of the study or a known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroid treatment.

Other

  • Has systolic blood pressure (BP) \>140 millimeters of mercury (mmHg) or diastolic BP \>90 mmHg.

Who the study is looking for

  • Participant must be \>=18 years of age.
  • Has a histologically or cytologically confirmed diagnosis of NSCLC without known targetable driver alteration (either non-squamous or squamous histology; mixed histology is allowed for which an approved targeted therapy is available in the 1L induction/maintenance therapy setting).
  • Has advanced (Stage IIIB or Stage IIIC, not amenable to definitive chemoradiotherapy) or metastatic (Stage IV) or metastatic (Stage IV) NSCLC.
  • Has completed at least 4 but no more than 6 cycles of SoC 1L platinum-based induction chemotherapy with pembrolizumab.
  • Has SD, PR, or CR of the NSCLC per Investigator's assessment after completion of 4 to 6 cycles of SoC 1L platinum-based induction chemotherapy with pembrolizumab.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Has a life expectancy of at least 12 weeks.
  • Has adequate organ and bone marrow function.
  • Must submit tumor specimens.
  • Must be able to swallow and retain orally administered study treatment.
  • A female is eligible to participate if she is not pregnant or breastfeeding and must follow contraceptive guidance during the treatment period and 180 days afterwards.
  • A male is eligible to participate if he agrees to contraceptive guidance and refrains from sperm donation during the intervention period and for at least 90 days after the last dose of study treatment.
  • Is able to understand the study procedures and agrees to participate in the study by providing written informed consent. Participants must be informed that their participation is voluntary. Participants will be required to sign a statement of informed consent to participate in the study.

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

Full criteria on ClinicalTrials.gov

Sites (164)

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

SiteCityCountrySite status
GSK Investigational Site
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Buenos AiresArgentinaUnknown status
GSK Investigational Site
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Cipoletti Rio NegroArgentinaUnknown status
GSK Investigational Site
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Ciudad Autonoma de Buenos AireArgentinaUnknown status
GSK Investigational Site
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CórdobaArgentinaUnknown status
GSK Investigational Site
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FloridaArgentinaUnknown status
GSK Investigational Site
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La PlataArgentinaUnknown status
GSK Investigational Site
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RosarioArgentinaUnknown status
GSK Investigational Site
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BallaratAustraliaUnknown status
GSK Investigational Site
Coordinator of this site? Confirm its status
BlacktownAustraliaUnknown status
GSK Investigational Site
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HeidelbergAustraliaUnknown status
GSK Investigational Site
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HobartAustraliaUnknown status
Antwerp University Hospital
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EdegemBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
Multiprofessional Hospital For Active Treatment Park Hospital Ltd.
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BranipoleBulgariaCompleted
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
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PanagyurishteBulgariaCompleted
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD
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PlevenBulgariaCompleted
Complex Oncology Center Ruse EOOD
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RuseBulgariaCompleted
MBAL Serdika Ltd.
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SofiaBulgariaCompleted
GSK Investigational Site
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Belo HorizonteBrazilUnknown status
GSK Investigational Site
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Cachoeiro de ItapemirimBrazilUnknown status
GSK Investigational Site
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CuritibaBrazilUnknown status
GSK Investigational Site
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Porto AlegreBrazilUnknown status
GSK Investigational Site
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Rio de JaneiroBrazilUnknown status
GSK Investigational Site
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São PauloBrazilUnknown status
GSK Investigational Site
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UberlândiaBrazilUnknown status
GSK Investigational Site
Coordinator of this site? Confirm its status
LausanneSwitzerlandUnknown status
GSK Investigational Site
Coordinator of this site? Confirm its status
SantiagoChileUnknown status
GSK Investigational Site
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TemucoChileUnknown status
GSK Investigational Site
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BogotáColombiaUnknown status
GSK Investigational Site
Coordinator of this site? Confirm its status
MonteríaColombiaUnknown status
Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH
Coordinator of this site? Confirm its status
BerlinGermanyCompleted
Universitaetsklinikum Essen (AoR)
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EssenGermanyCompleted
Asklepios Fachkliniken Muenchen-Gauting
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GautingGermanyCompleted
LungenClinic Grosshansdorf GmbH
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GrosshansdorfGermanyCompleted
Martha-Maria Krankenhaus Halle-Doelau gGmbH
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Halle (saale)GermanyCompleted
Hamato-Onkologie Hamburg
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HamburgGermanyCompleted
Klinikum Region Hannover GmbH
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HanoverGermanyCompleted
Thoraxklinik Heidelberg gGmbH
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HeidelbergGermanyCompleted
Lungenklinik Hemer Deutscher Gemeinschafts-Diakonieverband GmbH
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HemerGermanyCompleted
Universitaetsklinikum Jena KöR
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JenaGermanyCompleted
Muenchen Klinik gGmbH
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MunichGermanyCompleted
Klinikum der Universitaet Muenchen AöR
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MunichGermanyCompleted
Robert Bosch Gesellschaft fuer medizinische Forschung mbH
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StuttgartGermanyCompleted
MVZ-Onkologie Velbert GbR
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VelbertGermanyCompleted
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainCompleted
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Hospital Clinic de Barcelona
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BarcelonaSpainCompleted
Hospital Universitario Reina Sofia
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CórdobaSpainCompleted
Institut Català d'Oncologia
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GironaSpainCompleted
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainCompleted
Hospital Universitario 12 de Octubre
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MadridSpainCompleted
Hospital Universitario La Paz
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MadridSpainCompleted
Hospital General Universitario Gregorio Marañón
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MadridSpainCompleted
Hospital Universitario HM Sanchinarro
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MadridSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainCompleted
Clínica Universidad de navarra
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PamplonaSpainCompleted
Hospital Universitario Marqués de Valdecilla
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SantanderSpainCompleted
Hospital Clinico Universitario Lozano Blesa
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ZaragozaSpainCompleted
Centre Hospitalier Régional et Universitaire de Brest
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BrestFranceCompleted
Centre Hospitalier Intercommunal Creteil
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Creteil CedexFranceCompleted
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceCompleted
Centre Hospitalier Universitaire de Lille
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LilleFranceCompleted
Assistance Publique Hopitaux de Paris
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ParisFranceCompleted
Assistance Publique Hopitaux De Paris
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Paris Cedex 18FranceCompleted
Centre Hospitalier Universitaire de Rennes
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RennesFranceCompleted
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceCompleted
Institut de Cancérologie Strasbourg Europe
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StrasbourgFranceCompleted
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
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Toulon CedexFranceCompleted
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceCompleted
GSK Investigational Site
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BournemouthUnited KingdomUnknown status
GSK Investigational Site
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DundeeUnited KingdomUnknown status
GSK Investigational Site
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MiddlesexUnited KingdomUnknown status
GSK Investigational Site
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OxfordUnited KingdomUnknown status
GSK Investigational Site
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WrexhamUnited KingdomUnknown status
University General Hospital Attikon
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AthensGreeceCompleted
Alexandra Hospital
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AthensGreeceCompleted
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceCompleted
Henry Dunant Hospital Center
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AthensGreeceCompleted
Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.
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CholargosGreeceCompleted
University General Hospital of Heraklion
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HeraklionGreeceCompleted
General University Hospital of Larissa
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LarissaGreeceCompleted
Athens Medical Center S.A.
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MaroussiGreeceCompleted
Olympion Therapeftirio General Clinic Of Patras S.A.
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PatraGreeceCompleted
General University Hospital Of Patras
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PatrasGreeceCompleted
Metropolitan Hospital
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PireasGreeceCompleted
Metaxa Cancer Center Hospital Of Piraeus
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PireasGreeceCompleted
Theageneio Cancer Hospital
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ThessalonikiGreeceCompleted
Athens Medical Center S.A.
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ThessalonikiGreeceCompleted
Bioclinic S.A.
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ThessalonikiGreeceCompleted
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceCompleted
Euromedica General Clinic of Thessaloniki
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ThessalonikiGreeceCompleted
Orszagos Onkologiai Intezet
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Budapest XIIHungaryCompleted
Matrai Gyogyintezet
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GyöngyösHungaryCompleted
Komarom-Esztergom Varmegyei Szent Borbala Korhaz
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TatabányaHungaryCompleted
Toeroekbalinti Tuedogyogyintezet
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TorokbalintHungaryCompleted
St James's Hospital
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Dublin 8IrelandCompleted
AORN San Giuseppe Moscati Avellino
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AvellinoItalyCompleted
Centro di Riferimento Oncologico di Aviano
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AvianoItalyCompleted
Istituto Tumori Bari Giovanni Paolo II
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BariItalyCompleted
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
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CataniaItalyCompleted
Careggi University Hospital
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FlorenceItalyCompleted
Azienda Ulss 9 Scaligera
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LegnagoItalyCompleted
Ospedale San Raffaele S.r.l.
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MilanItalyCompleted
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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MilanItalyCompleted
Fondazione IRCCS - Istituto Nazionale dei Tumori
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MilanItalyCompleted
Fondazione IRCCS San Gerardo dei Tintori
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MonzaItalyCompleted
Azienda Ospedaliera dei Colli
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NaplesItalyCompleted
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyCompleted
Azienda Ospedaliero Universitaria Pisana
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PisaItalyCompleted
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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RomeItalyCompleted
GSK Investigational Site
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Seongnam-siSouth KoreaUnknown status
GSK Investigational Site
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Seongnam-si Gyeonggi-doSouth KoreaUnknown status
GSK Investigational Site
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SeoulSouth KoreaUnknown status
GSK Investigational Site
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Suwon Kyunggi-doSouth KoreaUnknown status
GSK Investigational Site
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Mexico CityMexicoUnknown status
GSK Investigational Site
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MonterreyMexicoUnknown status
GSK Investigational Site
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Puebla PueblaMexicoUnknown status
Meander Medisch Centrum
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AmersfoortNetherlandsCompleted
Netherlands Cancer Institute
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AmsterdamNetherlandsCompleted
Medisch Spectrum Twente
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EnschedeNetherlandsCompleted
University Hospital Maastricht
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MaastrichtNetherlandsCompleted
Jeroen Bosch Ziekenhuis
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's-HertogenboschNetherlandsCompleted
St Antonius Ziekenhuis
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UtrechtNetherlandsCompleted
Isala Klinieken Stichting
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ZwolleNetherlandsCompleted
Vestre Viken HF
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DrammenNorwayCompleted
Akershus University Hospital
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LoerenskogNorwayCompleted
Oslo University Hospital HF
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OsloNorwayCompleted
GSK Investigational Site
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LimaPeruUnknown status
Uniwersytecki Szpital Kliniczny w Bialymstoku
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BialystokPolandCompleted
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
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LodzPolandCompleted
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandCompleted
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaCompleted
Oncomed S.R.L.
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TimisoaraRomaniaCompleted
GSK Investigational Site
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MoscowRussiaUnknown status
GSK Investigational Site
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Nizhny NovgorodRussiaUnknown status
GSK Investigational Site
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OmskRussiaUnknown status
GSK Investigational Site
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Saint PetersburgRussiaUnknown status
Region Gaevleborg
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GavleSwedenCompleted
Karolinska University Hospital
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SolnaSwedenCompleted
Uppsala University Hospital
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UppsalaSwedenCompleted
GSK Investigational Site
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AtlantaUnited StatesUnknown status
GSK Investigational Site
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CharlotteUnited StatesUnknown status
GSK Investigational Site
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ChattanoogaUnited StatesUnknown status
GSK Investigational Site
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DallasUnited StatesUnknown status
GSK Investigational Site
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FairfaxUnited StatesUnknown status
GSK Investigational Site
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FullertonUnited StatesUnknown status
GSK Investigational Site
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Iowa CityUnited StatesUnknown status
GSK Investigational Site
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Lone TreeUnited StatesUnknown status
GSK Investigational Site
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Los AngelesUnited StatesUnknown status
GSK Investigational Site
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MineolaUnited StatesUnknown status
GSK Investigational Site
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NashvilleUnited StatesUnknown status
GSK Investigational Site
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NewnanUnited StatesUnknown status
GSK Investigational Site
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New YorkUnited StatesUnknown status
GSK Investigational Site
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NilesUnited StatesUnknown status
GSK Investigational Site
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NorwichUnited StatesUnknown status
GSK Investigational Site
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PittsburghUnited StatesUnknown status
GSK Investigational Site
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San AntonioUnited StatesUnknown status
GSK Investigational Site
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Sugar LandUnited StatesUnknown status
GSK Investigational Site
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TallahasseeUnited StatesUnknown status
GSK Investigational Site
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WacoUnited StatesUnknown status
GSK Investigational Site
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WorcesterUnited StatesUnknown status
GSK Investigational Site
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AnkaraTurkey (Türkiye)Unknown status
GSK Investigational Site
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EdirneTurkey (Türkiye)Unknown status
GSK Investigational Site
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IstanbulTurkey (Türkiye)Unknown status

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