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

Last updated: March 25, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

3

Condition

Lung Cancer

Non-small Cell Lung Cancer

Cancer

Treatment

Pembrolizumab (+) Berahyaluronidase alfa

Pembrolizumab

MK-3475A

Clinical Study ID

NCT06698042
3475A-F84
U1111-1306-1214
jRCT2031240445
MK-3475A-F84
2024-513165-39
  • Ages > 18
  • All Genders

Study Summary

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 compare what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of squamous or nonsquamousnon-small cell lung cancer (NSCLC).

  • Measurable disease as assessed by the local site investigator/radiology.

Exclusion

Exclusion Criteria:

  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cellelements.

  • Received prior systemic anticancer therapy for their metastatic NSCLC.

  • Known additional malignancy that is progressing or has required active treatmentwithin the past 3 years.

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

  • Active autoimmune disease that has required systemic treatment in the past 2 years.

  • History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease.

  • Active infection requiring systemic therapy.

Study Design

Total Participants: 160
Treatment Group(s): 3
Primary Treatment: Pembrolizumab (+) Berahyaluronidase alfa
Phase: 3
Study Start date:
November 21, 2024
Estimated Completion Date:
February 11, 2030

Connect with a study center

  • Beijing Peking Union Medical College Hospital ( Site 5000)

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Chongqing University Three Gorges Hospital ( Site 5018)

    Chongqing, Chongqing 404000
    China

    Active - Recruiting

  • Fujian Province Cancer Hospital ( Site 5007)

    Fuzhou, Fujian 350014
    China

    Active - Recruiting

  • The First Affiliated hospital of Xiamen University ( Site 5008)

    XiaMen, Fujian 361003
    China

    Active - Recruiting

  • Southern Medical University Nanfang Hospital ( Site 5003)

    Guangzhou, Guangdong 510515
    China

    Active - Recruiting

  • Huizhou Central People's Hospital ( Site 5004)

    Huizhou, Guangdong 516001
    China

    Active - Recruiting

  • Jiangmen Center Hospital ( Site 5001)

    Jiangmen, Guangdong 529030
    China

    Active - Recruiting

  • Liuzhou People's Hospital ( Site 5009)

    Liuzhou, Guangxi 545006
    China

    Active - Recruiting

  • Wuhan Union Hospital Cancer Center-Cancer Center ( Site 5015)

    Wuhan, Hubei 430048
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University ( Site 5019)

    Nanchang, Jiangxi 330006
    China

    Active - Recruiting

  • Jinan Central Hospital ( Site 5012)

    Jinan, Shandong 250013
    China

    Active - Recruiting

  • Shanghai Pulmonary Hospital ( Site 5010)

    Shanghai, Shanghai 200433
    China

    Active - Recruiting

  • Sichuan Cancer Hospital. ( Site 5006)

    Chengdu, Sichuan 610213
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5021)

    Hangzhou, Zhejiang 310016
    China

    Active - Recruiting

  • Taizhou Hospital of Zhejiang Province ( Site 5002)

    Linhai, Zhejiang 317000
    China

    Active - Recruiting

  • CELAN,S.A ( Site 1104)

    Guatemala, 01010
    Guatemala

    Active - Recruiting

  • MEDI-K ( Site 1101)

    Guatemala, 01009
    Guatemala

    Active - Recruiting

  • Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1102)

    Guatemala, 01010
    Guatemala

    Active - Recruiting

  • Centro Medico Integral De Cancerología (CEMIC) ( Site 1103)

    Quetzaltenango, 09002
    Guatemala

    Active - Recruiting

  • Fujita Health University Hospital ( Site 4004)

    Toyoake, Aichi 470-1192
    Japan

    Active - Recruiting

  • Takarazuka City Hospital ( Site 4006)

    Takarazuka, Hyogo 665-0827
    Japan

    Active - Recruiting

  • Kanagawa Cardiovascular and Respiratory Center ( Site 4002)

    Yokohama, Kanagawa 236-0051
    Japan

    Active - Recruiting

  • Miyagi Cancer Center ( Site 4000)

    Natori, Miyagi 981-1293
    Japan

    Active - Recruiting

  • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 4009)

    Sakai, Osaka 591-8555
    Japan

    Active - Recruiting

  • Saitama Prefectural Cancer Center ( Site 4001)

    Kitaadachi-gun, Saitama 362-0806
    Japan

    Active - Recruiting

  • Tochigi Cancer Center ( Site 4008)

    Utsunomiya, Tochigi 320-0834
    Japan

    Active - Recruiting

  • Juntendo University Hospital ( Site 4003)

    Bunkyo, Tokyo 113-8431
    Japan

    Active - Recruiting

  • Pusan National University Hospital ( Site 3002)

    Pusan Kwangyokshi, Pusan-Kwangyokshi 49241
    Korea, Republic of

    Active - Recruiting

  • Chungnam National University Hospital ( Site 3003)

    Daejeon, Taejon-Kwangyokshi 35015
    Korea, Republic of

    Active - Recruiting

  • Korea University Guro Hospital ( Site 3001)

    Seoul, 8308
    Korea, Republic of

    Active - Recruiting

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2305)

    Siedlce, Mazowieckie 08-110
    Poland

    Active - Recruiting

  • Narodowy Instytut Onkologii ( Site 2303)

    Warsaw, Mazowieckie 02-781
    Poland

    Active - Recruiting

  • SC Radiotherapy Center Cluj SRL ( Site 2203)

    Floresti, Cluj 407280
    Romania

    Active - Recruiting

  • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2201)

    Craiova, Dolj 200746
    Romania

    Active - Recruiting

  • Institutul Oncologic ( Site 2202)

    Cluj, 400015
    Romania

    Active - Recruiting

  • Hospital General Universitari Vall d Hebron ( Site 2450)

    Barcelona, 08035
    Spain

    Active - Recruiting

  • INSTITUTO CATALAN DE ONCOLOGIA- L´HOSPITALET DE LLOBREGAT ( Site 2451)

    Barcelona, 08908
    Spain

    Active - Recruiting

  • Hospital Universitario Juan Ramon Jimenez ( Site 2453)

    Huelva, 21005
    Spain

    Active - Recruiting

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)

    Ankara, 6230
    Turkey

    Active - Recruiting

  • Illinois Cancer Care ( Site 0101)

    Peoria, Illinois 61615
    United States

    Active - Recruiting

  • Montefiore Medical Center ( Site 0104)

    Bronx, New York 10461
    United States

    Active - Recruiting

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