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NCT06698042Active, not recruitingPhase 3

A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)

A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS 50% or Greater

Source: ClinicalTrials.gov · Last updated 21 Jul 2026

Brief summary (registry, in English)

Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that is metastatic, which means cancer has spread to other parts of the body. Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to learn what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
67 (actual)
First submitted
18 Nov 2024
Start date
21 Nov 2024
Primary completion date
12 Mar 2026
Lead sponsor
Merck Sharp & Dohme LLC
Diseases
Lung cancer
NCT number
NCT06698042
EU CT number
2024-513165-39-00

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 67
  • From 21 Nov 2024 to the primary completion date, 12 Mar 2026
  • 67 sites in 12 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

  • Received prior systemic anticancer therapy for their metastatic NSCLC.

Other illness

  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Active autoimmune disease that has required systemic treatment in the past 2 years.
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Active infection requiring systemic therapy.

Other

  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.

Who the study is looking for

  • Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
  • Measurable disease as assessed by the local site investigator/radiology.

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

Full criteria on ClinicalTrials.gov

Sites (67)

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

SiteCityCountrySite status
Beijing Peking Union Medical College Hospital ( Site 5000)
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BeijingChinaUnknown status
Jilin Province Tumor Hospital ( Site 5014)
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ChangchunChinaUnknown status
West China Hospital of Sichuan University ( Site 5016)
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ChengduChinaUnknown status
Sichuan Cancer Hospital. ( Site 5006)
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ChengduChinaUnknown status
Chongqing University Three Gorges Hospital ( Site 5018)
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ChongqingChinaUnknown status
Fujian Province Cancer Hospital ( Site 5007)
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FuzhouChinaUnknown status
Southern Medical University Nanfang Hospital ( Site 5003)
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GuangzhouChinaUnknown status
The first affiliated hospital, Sun Yat-Sen university ( Site 5011)
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GuangzhouChinaUnknown status
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5021)
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HangzhouChinaUnknown status
Huizhou Central People's Hospital ( Site 5004)
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HuizhouChinaUnknown status
Jiangmen Center Hospital ( Site 5001)
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JiangmenChinaUnknown status
Jinan Central Hospital ( Site 5012)
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JinanChinaUnknown status
Taizhou Hospital of Zhejiang Province ( Site 5002)
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LinhaiChinaUnknown status
Liuzhou People's Hospital ( Site 5009)
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LiuzhouChinaUnknown status
The First Affiliated Hospital of Nanchang University ( Site 5019)
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NanchangChinaUnknown status
Shanghai Pulmonary Hospital ( Site 5010)
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ShanghaiChinaUnknown status
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 5015)
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WuhanChinaUnknown status
The First Affiliated hospital of Xiamen University ( Site 5008)
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XiamenChinaUnknown status
Universitaetsklinikum Jena KöR
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JenaGermanyActive, not recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainCompleted
Fundacion Onkologikoa Fundazioa
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DonostiaSpainCompleted
Hospital Universitario Juan Ramon Jimenez
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HuelvaSpainCompleted
Institut Catala D'oncologia
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L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario Virgen De La Macarena
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SevillaSpainCompleted
Torbay Hospital ( Site 2100)
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TorquayUnited KingdomUnknown status
The Royal Cornwall Hospital ( Site 2102)
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TruroUnited KingdomUnknown status
CELAN,S.A ( Site 1104)
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Guatemala CityGuatemalaUnknown status
MEDI-K ( Site 1101)
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Guatemala CityGuatemalaUnknown status
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1102)
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Guatemala CityGuatemalaUnknown status
Centro Medico Integral De Cancerología (CEMIC) ( Site 1103)
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QuetzaltenangoGuatemalaUnknown status
Juntendo University Hospital ( Site 4003)
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BunkyoJapanUnknown status
Fukushima Medical University Hospital ( Site 4011)
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FukushimaJapanUnknown status
Saitama Prefectural Cancer Center ( Site 4001)
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Kitaadachi-gunJapanUnknown status
Hospital of the University of Occupational and Environmental Health, Japan ( Site 4010)
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KitakyushuJapanUnknown status
Kochi Medical School Hospital ( Site 4012)
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NankokuJapanUnknown status
Miyagi Cancer Center ( Site 4000)
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Natori-shiJapanUnknown status
Osaka International Cancer Institute ( Site 4005)
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OsakaJapanUnknown status
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 4009)
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SakaiJapanUnknown status
Takarazuka City Hospital ( Site 4006)
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TakarazukaJapanUnknown status
Ehime University Hospital ( Site 4007)
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TōonJapanUnknown status
Fujita Health University Hospital ( Site 4004)
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ToyoakeJapanUnknown status
Tochigi Cancer Center ( Site 4008)
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UtsunomiyaJapanUnknown status
Kanagawa Cardiovascular and Respiratory Center ( Site 4002)
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YokohamaJapanUnknown status
Chungnam National University Hospital ( Site 3003)
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DaejeonSouth KoreaUnknown status
Pusan National University Hospital ( Site 3002)
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Pusan KwangyokshiSouth KoreaUnknown status
Korea University Guro Hospital ( Site 3001)
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SeoulSouth KoreaUnknown status
Oncosalud ( Site 1000)
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LimaPeruUnknown status
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1004)
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LimaPeruUnknown status
Clínica Internacional - Sede San Borja ( Site 1002)
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LimaPeruUnknown status
Clínica San Antonio ( Site 1006)
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TrujilloPeruUnknown status
Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie
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KoszalinPolandActive, not recruiting
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o.
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SiedlcePolandActive, not recruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy
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WarsawPolandActive, not recruiting
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaActive, not recruiting
Centrul De Oncologie SF Nectarie S.R.L.
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CraiovaRomaniaActive, not recruiting
Radiotherapy Center Cluj S.R.L.
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FlorestiRomaniaActive, not recruiting
Spitalul Municipal Ploiesti
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PloieştiRomaniaActive, not recruiting
University of Cincinnati Medical Center ( Site 0112)
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CincinnatiUnited StatesUnknown status
Providence Medical Foundation ( Site 0117)
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FullertonUnited StatesUnknown status
Illinois Cancer Care ( Site 0101)
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PeoriaUnited StatesUnknown status
Montefiore Medical Center ( Site 0104)
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The BronxUnited StatesUnknown status
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)
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AnkaraTurkey (Türkiye)Unknown status
Gulhane Egitim Arastirma Hastanesi ( Site 2504)
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AnkaraTurkey (Türkiye)Unknown status
Ankara Bilkent Sehir Hastanesi ( Site 2503)
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AnkaraTurkey (Türkiye)Unknown status
Gazi University Health Research and Application Center Gazi Hospital-Oncology ( Site 2502)
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AnkaraTurkey (Türkiye)Unknown status
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2501)
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BornovaTurkey (Türkiye)Unknown status
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2506)
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IstanbulTurkey (Türkiye)Unknown status

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