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
Sites (67)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Peking Union Medical College Hospital ( Site 5000) Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Jilin Province Tumor Hospital ( Site 5014) Coordinator of this site? Confirm its status | Changchun | China | Unknown status |
| West China Hospital of Sichuan University ( Site 5016) Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Sichuan Cancer Hospital. ( Site 5006) Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Chongqing University Three Gorges Hospital ( Site 5018) Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
| Fujian Province Cancer Hospital ( Site 5007) Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
| Southern Medical University Nanfang Hospital ( Site 5003) Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| The first affiliated hospital, Sun Yat-Sen university ( Site 5011) Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5021) Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Huizhou Central People's Hospital ( Site 5004) Coordinator of this site? Confirm its status | Huizhou | China | Unknown status |
| Jiangmen Center Hospital ( Site 5001) Coordinator of this site? Confirm its status | Jiangmen | China | Unknown status |
| Jinan Central Hospital ( Site 5012) Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
| Taizhou Hospital of Zhejiang Province ( Site 5002) Coordinator of this site? Confirm its status | Linhai | China | Unknown status |
| Liuzhou People's Hospital ( Site 5009) Coordinator of this site? Confirm its status | Liuzhou | China | Unknown status |
| The First Affiliated Hospital of Nanchang University ( Site 5019) Coordinator of this site? Confirm its status | Nanchang | China | Unknown status |
| Shanghai Pulmonary Hospital ( Site 5010) Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Wuhan Union Hospital Cancer Center-Cancer Center ( Site 5015) Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
| The First Affiliated hospital of Xiamen University ( Site 5008) Coordinator of this site? Confirm its status | Xiamen | China | Unknown status |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Completed |
| Fundacion Onkologikoa Fundazioa Coordinator of this site? Confirm its status | Donostia | Spain | Completed |
| Hospital Universitario Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Completed |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Completed |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Completed |
| Torbay Hospital ( Site 2100) Coordinator of this site? Confirm its status | Torquay | United Kingdom | Unknown status |
| The Royal Cornwall Hospital ( Site 2102) Coordinator of this site? Confirm its status | Truro | United Kingdom | Unknown status |
| CELAN,S.A ( Site 1104) Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Unknown status |
| MEDI-K ( Site 1101) Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Unknown status |
| Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1102) Coordinator of this site? Confirm its status | Guatemala City | Guatemala | Unknown status |
| Centro Medico Integral De Cancerología (CEMIC) ( Site 1103) Coordinator of this site? Confirm its status | Quetzaltenango | Guatemala | Unknown status |
| Juntendo University Hospital ( Site 4003) Coordinator of this site? Confirm its status | Bunkyo | Japan | Unknown status |
| Fukushima Medical University Hospital ( Site 4011) Coordinator of this site? Confirm its status | Fukushima | Japan | Unknown status |
| Saitama Prefectural Cancer Center ( Site 4001) Coordinator of this site? Confirm its status | Kitaadachi-gun | Japan | Unknown status |
| Hospital of the University of Occupational and Environmental Health, Japan ( Site 4010) Coordinator of this site? Confirm its status | Kitakyushu | Japan | Unknown status |
| Kochi Medical School Hospital ( Site 4012) Coordinator of this site? Confirm its status | Nankoku | Japan | Unknown status |
| Miyagi Cancer Center ( Site 4000) Coordinator of this site? Confirm its status | Natori-shi | Japan | Unknown status |
| Osaka International Cancer Institute ( Site 4005) Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| National Hospital Organization Kinki-chuo Chest Medical Center ( Site 4009) Coordinator of this site? Confirm its status | Sakai | Japan | Unknown status |
| Takarazuka City Hospital ( Site 4006) Coordinator of this site? Confirm its status | Takarazuka | Japan | Unknown status |
| Ehime University Hospital ( Site 4007) Coordinator of this site? Confirm its status | Tōon | Japan | Unknown status |
| Fujita Health University Hospital ( Site 4004) Coordinator of this site? Confirm its status | Toyoake | Japan | Unknown status |
| Tochigi Cancer Center ( Site 4008) Coordinator of this site? Confirm its status | Utsunomiya | Japan | Unknown status |
| Kanagawa Cardiovascular and Respiratory Center ( Site 4002) Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Chungnam National University Hospital ( Site 3003) Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Pusan National University Hospital ( Site 3002) Coordinator of this site? Confirm its status | Pusan Kwangyokshi | South Korea | Unknown status |
| Korea University Guro Hospital ( Site 3001) Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Oncosalud ( Site 1000) Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1004) Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Clínica Internacional - Sede San Borja ( Site 1002) Coordinator of this site? Confirm its status | Lima | Peru | Unknown status |
| Clínica San Antonio ( Site 1006) Coordinator of this site? Confirm its status | Trujillo | Peru | Unknown status |
| Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie Coordinator of this site? Confirm its status | Koszalin | Poland | Active, not recruiting |
| Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Coordinator of this site? Confirm its status | Siedlce | 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 |
| Spitalul Municipal Ploiesti Coordinator of this site? Confirm its status | Ploieşti | Romania | Active, not recruiting |
| University of Cincinnati Medical Center ( Site 0112) Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Providence Medical Foundation ( Site 0117) Coordinator of this site? Confirm its status | Fullerton | United States | Unknown status |
| Illinois Cancer Care ( Site 0101) Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Montefiore Medical Center ( Site 0104) Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Gulhane Egitim Arastirma Hastanesi ( Site 2504) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ankara Bilkent Sehir Hastanesi ( Site 2503) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Gazi University Health Research and Application Center Gazi Hospital-Oncology ( Site 2502) Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2501) Coordinator of this site? Confirm its status | Bornova | Turkey (Türkiye) | Unknown status |
| TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2506) Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.