NCT05722015Active, not recruitingPhase 3
A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)
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, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer
Source: ClinicalTrials.gov · Last updated 26 Aug 2026
Brief summary (registry, in English)
This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 377 (actual)
- First submitted
- 27 Jan 2023
- Start date
- 14 Feb 2023
- Primary completion date
- 12 Jul 2024
- Lead sponsor
- Merck Sharp & Dohme LLC
- Diseases
- Lung cancer
- NCT number
- NCT05722015
- EU CT number
- 2022-501506-36-00
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 377
- From 14 Feb 2023 to the primary completion date, 12 Jul 2024
- 109 sites in 16 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 systemic anticancer therapy for metastatic NSCLC
- Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
- Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids
- Has received radiation therapy to the lung (\>30 Gray) within 6 months of start of study intervention
- Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
- Has not adequately recovered from major surgery or has ongoing surgical complications
Other illness
- Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has an active autoimmune disease that has required systemic treatment in past 2 years
- Has an active infection requiring systemic therapy
- Has a history of human immunodeficiency virus (HIV) infection
- Has a history of Hepatitis B or C
- Has a history of allogenic tissue/solid organ transplant
Who the study is looking for
- Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC)
- Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
- Has a life expectancy of at least 3 months
Criteria the registry did not label
- The key inclusion and exclusion criteria include but are not limited to the following:
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (109)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Instituto Alexander Fleming ( Site 1008) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Clinica Adventista Belgrano-Oncology ( Site 1004) Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005) Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aires | Argentina | Unknown status |
| Hospital Italiano de Córdoba ( Site 1000) Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001) Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| Sanatorio Parque ( Site 1003) Coordinator of this site? Confirm its status | Rosario | Argentina | Unknown status |
| CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102) Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| Instituto Joinvilense de Hematologia e Oncologia ( Site 1101) Coordinator of this site? Confirm its status | Joinville | Brazil | Unknown status |
| Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1100) Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital de Cancer de Pernambuco ( Site 1107) Coordinator of this site? Confirm its status | Recife | Brazil | Unknown status |
| A. C. Camargo Cancer Center ( Site 1106) Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| IC La Serena Research ( Site 1207) Coordinator of this site? Confirm its status | La Serena | Chile | Unknown status |
| Bradfordhill-Clinical Area ( Site 1202) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Instituto Nacional del Cancer-CR Investigación ( Site 1211) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Oncovida ( Site 1209) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| FALP-UIDO ( Site 1203) Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Oncocentro Valdivia ( Site 1201) Coordinator of this site? Confirm its status | Valdivia | Chile | Unknown status |
| Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501) Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510) Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Beijing Chest Hospital,Capital Medical University ( Site 4511) Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Fujian Provincial Cancer Hospital ( Site 4517) Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 4519) Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514) Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503) Coordinator of this site? Confirm its status | Hefei | China | Unknown status |
| Jiangmen Center Hospital ( Site 4509) Coordinator of this site? Confirm its status | Jiangmen | China | Unknown status |
| Taizhou Hospital of Zhejiang Province ( Site 4508) Coordinator of this site? Confirm its status | Linhai | China | Unknown status |
| The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515) Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Fudan University Shanghai Cancer Center-Oncology ( Site 4512) Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| ShenZhen People's Hospital ( Site 4504) Coordinator of this site? Confirm its status | Shenzhen | China | Unknown status |
| Shanxi Cancer Hospital ( Site 4521) Coordinator of this site? Confirm its status | Taiyuan | China | Unknown status |
| Tianjin Chest Hospital ( Site 4518) Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Chongqing University Three Gorges Hospital ( Site 4516) Coordinator of this site? Confirm its status | Wanzhou | China | Unknown status |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 4502) Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520) Coordinator of this site? Confirm its status | Xi'an | China | Unknown status |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Complexo Hospitalario Universitario De Santiago Coordinator of this site? Confirm its status | Santiago de Compostela | Spain | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Completed |
| Centre Hospitalier Intercommunal De Cornouaille Coordinator of this site? Confirm its status | Quimper Cedex | France | Completed |
| Centre Hospitalier Regional Universitaire De Tours Coordinator of this site? Confirm its status | Tours Cedex 9 | France | Completed |
| Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404) Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Unknown status |
| MEDI-K ( Site 1403) Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Unknown status |
| Centro Regional de Sub Especialidades Médicas SA ( Site 1401) Coordinator of this site? Confirm its status | Quetzaltenango | Guatemala | Unknown status |
| Centro Medico Integral De Cancerología (CEMIC) ( Site 1400) Coordinator of this site? Confirm its status | Quetzaltenango | Guatemala | Unknown status |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Active, not recruiting |
| Koranyi National Institute For Pulmonology Coordinator of this site? Confirm its status | Budapest XII | Hungary | Active, not recruiting |
| Bacs-Kiskun Varmegyei Oktatokorhaz Coordinator of this site? Confirm its status | Kecskemét | Hungary | Active, not recruiting |
| Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointézet Coordinator of this site? Confirm its status | Szolnok | Hungary | Active, not recruiting |
| Református Pulmonológiai Centrum Coordinator of this site? Confirm its status | Törökbálint | Hungary | Active, not recruiting |
| Juntendo University Hospital ( Site 4413) Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| National Hospital Organization Kyushu Medical Center ( Site 4411) Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| National Hospital Organization Kyushu Cancer Center ( Site 4410) Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| Kansai Medical University Hospital ( Site 4408) Coordinator of this site? Confirm its status | Hirakata | Japan | Unknown status |
| Saitama Prefectural Cancer Center ( Site 4402) Coordinator of this site? Confirm its status | Kitaadachi-gun | Japan | Unknown status |
| Kurashiki Central Hospital ( Site 4409) Coordinator of this site? Confirm its status | Kurashiki | Japan | Unknown status |
| Kurume University Hospital ( Site 4412) Coordinator of this site? Confirm its status | Kurume | Japan | Unknown status |
| Miyagi Cancer Center ( Site 4401) Coordinator of this site? Confirm its status | Natori-shi | Japan | Unknown status |
| Osaka International Cancer Institute ( Site 4407) Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| Gunma Prefectural Cancer Center ( Site 4416) Coordinator of this site? Confirm its status | Ōta | Japan | Unknown status |
| National Hospital Organization Hokkaido Cancer Center ( Site 4415) Coordinator of this site? Confirm its status | Sapporo | Japan | Unknown status |
| Sendai Kousei Hospital ( Site 4400) Coordinator of this site? Confirm its status | Sendai | Japan | Unknown status |
| Shizuoka Cancer Center ( Site 4405) Coordinator of this site? Confirm its status | Sunto-gun, | Japan | Unknown status |
| Osaka Medical and Pharmaceutical University Hospital ( Site 4414) Coordinator of this site? Confirm its status | Takatsuki | Japan | Unknown status |
| Nippon Medical School Hospital ( Site 4403) Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| Fujita Health University Hospital ( Site 4406) Coordinator of this site? Confirm its status | Toyoake | Japan | Unknown status |
| Tochigi Cancer Center ( Site 4417) Coordinator of this site? Confirm its status | Utsunomiya | Japan | Unknown status |
| Kanagawa Cardiovascular and Respiratory Center ( Site 4404) Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Warminsko-Mazurskie Centrum Chorob Pluc w Olsztynie Coordinator of this site? Confirm its status | Olsztyn | Poland | Active, not recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Active, not recruiting |
| Centrul De Oncologie SF Nectarie S.R.L. Coordinator of this site? Confirm its status | Craiova | Romania | Active, not recruiting |
| Radiotherapy Center Cluj S.R.L. Coordinator of this site? Confirm its status | Floresti | Romania | Active, not recruiting |
| Oncomed S.R.L. Coordinator of this site? Confirm its status | Timisoara | Romania | Active, not recruiting |
| Division of Medical Oncology, Siriraj H ( Site 4303) Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Chulalongkorn University ( Site 4301) Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| Maharaj Nakorn Chiang Mai Hospital ( Site 4300) Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| Songklanagarind hospital ( Site 4302) Coordinator of this site? Confirm its status | Songkhla | Thailand | Unknown status |
| Changhua Christian Hospital ( Site 4203) Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| E-Da hospital ( Site 4208) Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Chang Gung Memorial Hospital at Kaohsiung ( Site 4200) Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207) Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| National Cheng Kung University Hospital ( Site 4202) Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| National Taiwan University Hospital-Oncology ( Site 4204) Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Cancer Center (NTUCC) ( Site 4205) Coordinator of this site? Confirm its status | Taipei City | Taiwan | Unknown status |
| Central Care Cancer Center - Bolivar ( Site 0017) Coordinator of this site? Confirm its status | Bolivar | United States | Unknown status |
| University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022) Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Clermont Oncology Center ( Site 0018) Coordinator of this site? Confirm its status | Clermont | United States | Unknown status |
| Hattiesburg Clinic Hematology/Oncology ( Site 0008) Coordinator of this site? Confirm its status | Hattiesburg | United States | Unknown status |
| Franciscan Health Lafayette East ( Site 0020) Coordinator of this site? Confirm its status | Lafayette | United States | Unknown status |
| Mid Florida Hematology and Oncology Center ( Site 0010) Coordinator of this site? Confirm its status | Orange City | United States | Unknown status |
| Mercy Health-Paducah Cancer Center ( Site 0006) Coordinator of this site? Confirm its status | Paducah | United States | Unknown status |
| St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023) Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Orchard Healthcare Research Inc. ( Site 0011) Coordinator of this site? Confirm its status | Skokie | United States | Unknown status |
| Cape Town Oncology Trials ( Site 2902) Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| The Oncology Centre ( Site 2901) Coordinator of this site? Confirm its status | Durban | South Africa | Unknown status |
| Medical Oncology Centre of Rosebank ( Site 2907) Coordinator of this site? Confirm its status | Johannesburg | South Africa | Unknown status |
| CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903) Coordinator of this site? Confirm its status | Port Elizabeth | South Africa | Unknown status |
| Steve Biko Academic Hospital-Medical Oncology ( Site 2904) Coordinator of this site? Confirm its status | Pretoria | South Africa | Unknown status |
| Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900) Coordinator of this site? Confirm its status | Sandton | South Africa | Unknown status |
| Ankara City Hospital-Medical Oncology ( Site 2501) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| I.E.U. Medical Point Hastanesi-Oncology ( Site 2507) Coordinator of this site? Confirm its status | Izmir | Turkey (Türkiye) | Unknown status |
| Memorial Kayseri Hastanesi ( Site 2500) Coordinator of this site? Confirm its status | Kayseri | Turkey (Türkiye) | Unknown status |
| İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503) Coordinator of this site? Confirm its status | Malatya | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.