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NCT04655976Active, not recruitingPhase 2/3

Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy

A Randomized, Open Label Phase 2/3 Study Comparing Cobolimab + Dostarlimab + Docetaxel To Dostarlimab + Docetaxel To Docetaxel Alone In Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed On Prior Anti-PD-(L)1 Therapy And Chemotherapy (COSTAR Lung)

Source: ClinicalTrials.gov · Last updated 1 Jul 2026

Brief summary (registry, in English)

This is a multi-center, parallel group treatment, Phase 2/3 open label study evaluating cobolimab in combination with dostarlimab and docetaxel in participants with advanced non-small cell Lung Cancer (NSCLC) who have progressed on prior anti-PD-(L)1 therapy and chemotherapy.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
758 (actual)
First submitted
30 Nov 2020
Start date
8 Dec 2020
Primary completion date
5 Jun 2025
Lead sponsor
GlaxoSmithKline
Diseases
Lung cancer
NCT number
NCT04655976
EU CT number
2023-507475-21-00
EudraCT number
2020-003433-37

What you commit to

  • Study type: Interventional · Phase 2/3
  • Participants enrolled: 758
  • From 8 Dec 2020 to the primary completion date, 5 Jun 2025
  • 137 sites in 24 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 been previously treated with an anti-PD-\[L\]1 or anti-programmed death-ligand 2 (anti-PD-\[L\]2) agent that resulted in permanent discontinuation due to an AE.
  • Participant has received radiation to the lung that is \>30 gray (Gy) within 6 months prior to the first dose of study treatment.
  • Participant has completed palliative radiotherapy within 7 days prior to the first dose of study treatment.
  • Participant has known new or progressive brain metastases and/or leptomeningeal metastases. Participants who have received prior therapy for their brain metastases and have radiographically stable central nervous system disease may participate, provided they are neurologically stable for at least 4 weeks before study entry and are off corticosteroids within 3 days prior to the first dose of study treatment.
  • Participant has tested positive for the following at Screening or within 3 months before the first dose of study treatment: a. Presence of hepatitis B surface antigen. b. Presence of hepatitis C antibody in the absence of a ribonucleic acid (RNA) test for hepatitis C virus. If a confirmatory RNA test is available, a positive test result will exclude a participant, while a negative test result (indicating absence of active infection) will allow the participant to enter into the study.
  • Participant has active autoimmune disease that required systemic treatment in the past 2 years, is immunocompromised in the opinion of the Investigator, or is receiving systemic immunosuppressive treatment.
  • Participant has received a live vaccine within 30 days of the first dose of study treatment. Seasonal flu vaccines that do not contain live virus and Coronavirus Disease 2019 (COVID-19) vaccines.
  • Participant is unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) for undergoing a biopsy procedure (in cases when a participant does not have an archival biopsy), other than an aspirin dose \<=1.3 grams (g) per day, for a 5-day period (8-day) period for long-acting agents, such as piroxicam).

Other illness

  • Participant has known human immunodeficiency virus (HIV) (positive for HIV 1 or HIV 2 antibodies).
  • Participant has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment of these conditions (including therapeutic thoracentesis or paracentesis) is eligible.
  • Participant has current interstitial lung disease, current pneumonitis, or a history of pneumonitis that required the use of glucocorticoids to assist with management.
  • Participant has pre-existing peripheral neuropathy that is Grade \>=2 by National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 criteria.

Lab values

  • Participant has been previously treated with an anti-T cell immunoglobulin and mucin domain containing 3 (anti-TIM-3) or anti-cytotoxic T lymphocyte associated protein 4 (CTLA 4) agent or docetaxel.
  • Participant has a documented sensitizing epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or c-ros oncogene 1 (ROS-1) mutation. Participants whose tumors have not been tested for these driver mutations and therefore who have unknown driver mutation status are not eligible. Participants with squamous histology do not need to be tested for these driver mutations.
  • Participant had radiological or clinical disease progression (i.e., worsening performance status, clinical symptoms, and laboratory data) \<=8 weeks after initiation of prior anti-programmed cell death protein 1 (anti-PD-1) or anti-PD-L1 antibody. The clinical disease progression should have been confirmed by a subsequent radiological scan.
  • Participant is ineligible if any of the following hepatic characteristics are present: a. Alanine aminotransferase (ALT) \>2.5 times upper limit normal (ULN) b. ALT and/or aspartate aminotransferase (AST) \>1.5 times ULN concomitant with alkaline phosphatase (ALP) \>2.5 times ULN; c. Bilirubin \>1 times ULN; d. Current active liver or biliary disease (with the exception of Gilbert's syndrome or asymptomatic gallstones, liver metastases, or otherwise stable chronic liver disease per the Investigator's assessment).

Who the study is looking for

  • Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous cell carcinoma.
  • Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum based (e.g., cisplatin, carboplatin) doublet chemotherapy regimen and an anti-PD-1 or an anti-PD-(L)1 antibody.
  • Participant has measurable disease.
  • Participant has documented radiographic disease progression on prior platinum based chemotherapy and on or after prior anti-PD-(L)1 therapy.
  • Participant agrees to submit an archival formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen that was collected on or after diagnosis of metastatic disease. If archival tissue is not available, the participant must undergo biopsy prior to study entry.
  • Participant has an ECOG performance status score of 0 or 1.
  • Participant has a life expectancy of at least 3 months.
  • Participant has adequate Baseline organ function.
  • Participant has recovered from any prior treatment related toxicities.
  • Participant agrees to use contraception.

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

Full criteria on ClinicalTrials.gov

Sites (137)

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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FloridaArgentinaUnknown status
GSK Investigational Site
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La RiojaArgentinaUnknown status
GSK Investigational Site
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PergaminoArgentinaUnknown status
GSK Investigational Site
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RosarioArgentinaUnknown status
GSK Investigational Site
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ViedmaArgentinaUnknown status
GSK Investigational Site
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AshfordAustraliaUnknown status
GSK Investigational Site
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BallaratAustraliaUnknown status
GSK Investigational Site
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HobartAustraliaUnknown status
GSK Investigational Site
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MelbourneAustraliaUnknown status
GSK Investigational Site
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Mount WaverleyAustraliaUnknown status
GSK Investigational Site
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South BrisbaneAustraliaUnknown status
Onze-Lieve-Vrouwziekenhuis
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AalstBelgiumCompleted
JESSA Ziekenhuis
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HasseltBelgiumCompleted
Algemeen Ziekenhuis Groeninge
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KortrijkBelgiumCompleted
GSK Investigational Site
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BlumenauBrazilUnknown status
GSK Investigational Site
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FortalezaBrazilUnknown 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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SalvadorBrazilUnknown status
GSK Investigational Site
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São PauloBrazilUnknown status
GSK Investigational Site
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Greater SudburyCanadaUnknown status
GSK Investigational Site
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Greenfield ParkCanadaUnknown status
GSK Investigational Site
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KingstonCanadaUnknown status
GSK Investigational Site
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MontrealCanadaUnknown status
GSK Investigational Site
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OshawaCanadaUnknown status
Krankenhaus Nordwest GmbH
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Frankfurt am MainGermanyActive, not recruiting
Klinikum der Universitaet Muenchen AöR
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MunichGermanyActive, not recruiting
Complexo Hospitalario Universitario A Coruña
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A CoruñaSpainActive, not recruiting
Institut Catala d'Oncologia
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BadalonaSpainActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainActive, not recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainActive, not recruiting
Hospital Universitario De Burgos
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BurgosSpainActive, not recruiting
Hospital Universitario Reina Sofia
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CórdobaSpainActive, not recruiting
Complejo Hospitalario Universitario Insular Materno Infantil
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Las Palmas de Gran CanariaSpainActive, not recruiting
Hospital Universitario HM Sanchinarro
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MadridSpainActive, not recruiting
Hospital General Universitario Gregorio Marañón
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MadridSpainActive, not recruiting
Hospital Universitario La Paz
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MadridSpainActive, not recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainActive, not recruiting
Hospital Universitario 12 de Octubre
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MadridSpainActive, not recruiting
Hospital Universitario Puerta de Hierro de Majadahonda
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MajadahondaSpainActive, not recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainActive, not recruiting
Hospital Universitario Y Politecnico La Fe
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ValenciaSpainActive, not recruiting
Pohjois-Savon hyvinvointialue
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KuopioFinlandCompleted
Centre Hospitalier Intercommunal Creteil
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Creteil CedexFranceActive, not recruiting
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceActive, not recruiting
Institut Paoli-Calmettes
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MarseilleFranceActive, not recruiting
Centre Antoine Lacassagne
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Nice Cedex 2FranceActive, not recruiting
Centre Hospitalier Intercommunal De Cornouaille
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Quimper CedexFranceActive, not recruiting
Centre Hospitalier Universitaire de Rennes
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RennesFranceActive, not recruiting
Centre Hospitalier Regional Universitaire De Tours
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Tours Cedex 9FranceActive, not recruiting
GSK Investigational Site
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CardiffUnited KingdomUnknown status
GSK Investigational Site
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EdinburghUnited KingdomUnknown status
GSK Investigational Site
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LondonUnited KingdomUnknown status
GSK Investigational Site
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ManchesterUnited KingdomUnknown status
University General Hospital Attikon
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AthensGreeceActive, not recruiting
Thoracic General Hospital of Athens "I Sotiria"
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AthensGreeceActive, not recruiting
Alexandra Hospital
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AthensGreeceActive, not recruiting
Henry Dunant Hospital Center
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AthensGreeceActive, not recruiting
General University Hospital of Larissa
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LarissaGreeceActive, not recruiting
General University Hospital Of Patras
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PatrasGreeceActive, not recruiting
St. Luke's Hospital S.A.
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ThessalonikiGreeceActive, not recruiting
Athens Medical Center S.A.
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ThessalonikiGreeceActive, not recruiting
Geniko Nosokomeio Thessalonikis George Papanikolaou
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ThessalonikiGreeceActive, not recruiting
Azienda Ospedaliero-Universitaria delle Marche
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AnconaItalyCompleted
AORN San Giuseppe Moscati Avellino
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AvellinoItalyCompleted
Careggi University Hospital
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FlorenceItalyCompleted
Ospedale San Raffaele S.r.l.
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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
IRCCS Istituto Nazionale Tumori Fondazione Pascale
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NaplesItalyCompleted
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
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OrbassanoItalyCompleted
Hospital Santa Maria Della Misericordia
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PerugiaItalyCompleted
Azienda Ospedaliera Universitaria Senese
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SienaItalyCompleted
GSK Investigational Site
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KyotoJapanUnknown status
GSK Investigational Site
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MiyagiJapanUnknown status
GSK Investigational Site
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OsakaJapanUnknown status
GSK Investigational Site
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YamaguchiJapanUnknown status
GSK Investigational Site
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Cheongju Chungcheongbuk-doSouth KoreaUnknown status
GSK Investigational Site
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DaeguSouth KoreaUnknown status
GSK Investigational Site
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Gyeonggi-doSouth KoreaUnknown status
GSK Investigational Site
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PusanSouth 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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GuadajalaraMexicoUnknown 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
Medisch Spectrum Twente
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EnschedeNetherlandsActive, not recruiting
Universitair Medisch Centrum Groningen
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GroningenNetherlandsActive, not recruiting
Ziekenhuis St Jansdal
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HarderwijkNetherlandsActive, not recruiting
Stichting Radboud University Medical Center
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NijmegenNetherlandsActive, not recruiting
Isala Klinieken Stichting
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ZwolleNetherlandsActive, not recruiting
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy
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BydgoszczPolandActive, not recruiting
Szpitale Pomorskie Sp z o o
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GdyniaPolandActive, not recruiting
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
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LodzPolandActive, not recruiting
Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie
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OlsztynPolandActive, not recruiting
Ars Medical Sp. z o.o.
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PilaPolandActive, not recruiting
Med Polonia Sp z o.o.
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PoznanPolandActive, not recruiting
Memorial Healthcare International S R L
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BucharestRomaniaActive, not recruiting
Oncolab S.R.L.
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CraiovaRomaniaActive, not recruiting
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaActive, not recruiting
Radiology Therapeutic Center S.R.L.
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OtopeniRomaniaActive, not recruiting
Oncomed S.R.L.
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TimisoaraRomaniaActive, not recruiting
GSK Investigational Site
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ChelyabinskRussiaUnknown status
GSK Investigational Site
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Moscow RegionRussiaUnknown status
GSK Investigational Site
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PushkinRussiaUnknown 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
GSK Investigational Site
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DusitThailandUnknown status
GSK Investigational Site
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Kho Hong Hat YaiThailandUnknown status
GSK Investigational Site
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Khon KaenThailandUnknown status
GSK Investigational Site
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Pathum ThaniThailandUnknown status
GSK Investigational Site
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TaipeiTaiwanUnknown status
GSK Investigational Site
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EdgewoodUnited StatesUnknown status
GSK Investigational Site
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Fountain ValleyUnited StatesUnknown status
GSK Investigational Site
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FredericksburgUnited StatesUnknown status
GSK Investigational Site
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HonoluluUnited StatesUnknown status
GSK Investigational Site
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HoustonUnited StatesUnknown status
GSK Investigational Site
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Iowa CityUnited StatesUnknown status
GSK Investigational Site
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Las VegasUnited StatesUnknown status
GSK Investigational Site
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MineolaUnited StatesUnknown status
GSK Investigational Site
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New YorkUnited 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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Sioux FallsUnited StatesUnknown status
GSK Investigational Site
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TacomaUnited StatesUnknown status
GSK Investigational Site
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Walnut CreekUnited StatesUnknown status
GSK Investigational Site
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Washington D.C.United StatesUnknown status
GSK Investigational Site
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White PlainsUnited StatesUnknown status
GSK Investigational Site
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AdanaTurkey (Türkiye)Unknown status
GSK Investigational Site
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AntalyaTurkey (Türkiye)Unknown status
GSK Investigational Site
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IzmirTurkey (Türkiye)Unknown status

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