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

July 20, 2026 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Peking Union Medical College Hospital ( Site 5000)
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 404000
        • Chongqing University Three Gorges Hospital ( Site 5018)
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Fujian Province Cancer Hospital ( Site 5007)
      • Xiamen, Fujian, China, 361003
        • The First Affiliated hospital of Xiamen University ( Site 5008)
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • The first affiliated hospital, Sun Yat-Sen university ( Site 5011)
      • Guangzhou, Guangdong, China, 510515
        • Southern Medical University Nanfang Hospital ( Site 5003)
      • Huizhou, Guangdong, China, 516001
        • Huizhou Central People's Hospital ( Site 5004)
      • Jiangmen, Guangdong, China, 529030
        • Jiangmen Center Hospital ( Site 5001)
    • Guangxi
      • Liuzhou, Guangxi, China, 545006
        • Liuzhou People's Hospital ( Site 5009)
    • Hubei
      • Wuhan, Hubei, China, 430048
        • Wuhan Union Hospital Cancer Center-Cancer Center ( Site 5015)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University ( Site 5019)
    • Jilin
      • Changchun, Jilin, China, 130000
        • Jilin Province Tumor Hospital ( Site 5014)
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital ( Site 5012)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200433
        • Shanghai Pulmonary Hospital ( Site 5010)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University ( Site 5016)
      • Chengdu, Sichuan, China, 610213
        • Sichuan Cancer Hospital. ( Site 5006)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5021)
      • Linhai, Zhejiang, China, 317000
        • Taizhou Hospital of Zhejiang Province ( Site 5002)
  • Germany
    • Thuringia
      • Erfurt, Thuringia, Germany, 99089
        • HELIOS Klinikum Erfurt ( Site 2005)
      • Jena, Thuringia, Germany, 07747
        • Universitätsklinikum Jena ( Site 2002)
  • Guatemala
      • Guatemala City, Guatemala, 01009
        • MEDI-K ( Site 1101)
      • Guatemala City, Guatemala, 01010
        • CELAN,S.A ( Site 1104)
      • Guatemala City, Guatemala, 01010
        • Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1102)
      • Quetzaltenango, Guatemala, 09002
        • Centro Medico Integral De Cancerología (CEMIC) ( Site 1103)
  • Japan
      • Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital ( Site 4011)
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute ( Site 4005)
    • Aichi-ken
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Fujita Health University Hospital ( Site 4004)
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Ehime University Hospital ( Site 4007)
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 807-8556
        • Hospital of the University of Occupational and Environmental Health, Japan ( Site 4010)
    • Hyōgo
      • Takarazuka, Hyōgo, Japan, 665-0827
        • Takarazuka City Hospital ( Site 4006)
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0051
        • Kanagawa Cardiovascular and Respiratory Center ( Site 4002)
    • Kochi
      • Nankoku, Kochi, Japan, 783-8505
        • Kochi Medical School Hospital ( Site 4012)
    • Miyagi
      • Natori-shi, Miyagi, Japan, 981-1293
        • Miyagi Cancer Center ( Site 4000)
    • Osaka
      • Sakai, Osaka, Japan, 591-8555
        • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 4009)
    • Saitama
      • Kitaadachi-gun, Saitama, Japan, 362-0806
        • Saitama Prefectural Cancer Center ( Site 4001)
    • Tochigi
      • Utsunomiya, Tochigi, Japan, 320-0834
        • Tochigi Cancer Center ( Site 4008)
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8431
        • Juntendo University Hospital ( Site 4003)
  • Peru
      • Lima, Peru, 15036
        • Clínica Internacional - Sede San Borja ( Site 1002)
      • Lima, Peru, 15036
        • IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1004)
      • Lima, Peru, 15036
        • Oncosalud ( Site 1000)
    • La Libertad
      • Trujillo, La Libertad, Peru, 13008
        • Clínica San Antonio ( Site 1006)
  • Poland
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Poland, 08-110
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2305)
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Narodowy Instytut Onkologii ( Site 2303)
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Institutul Oncologic ( Site 2202)
    • Cluj
      • Floreşti, Cluj, Romania, 407280
        • SC Radiotherapy Center Cluj SRL ( Site 2203)
    • Dolj
      • Craiova, Dolj, Romania, 200746
        • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2201)
    • Prahova
      • Ploieşti, Prahova, Romania, 100337
        • Spitalul Municipal Schuller Ploiești ( Site 2204)
  • South Korea
      • Seoul, South Korea, 08308
        • Korea University Guro Hospital ( Site 3001)
    • Pusan-Kwangyokshi
      • Pusan Kwangyokshi, Pusan-Kwangyokshi, South Korea, 49241
        • Pusan National University Hospital ( Site 3002)
    • Taejon-Kwangyokshi
      • Daejeon, Taejon-Kwangyokshi, South Korea, 35015
        • Chungnam National University Hospital ( Site 3003)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital General Universitari Vall d Hebron ( Site 2450)
      • Barcelona, Spain, 08908
        • INSTITUTO CATALAN DE ONCOLOGIA- L´HOSPITALET DE LLOBREGAT ( Site 2451)
      • Huelva, Spain, 21005
        • Hospital Universitario Juan Ramon Jimenez ( Site 2453)
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena ( Site 2455)
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
        • Onkologikoa - Instituto Oncologico de San Sebastian ( Site 2454)
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06010
        • Gulhane Egitim Arastirma Hastanesi ( Site 2504)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)
      • Ankara, Turkey (Türkiye), 06560
        • Gazi University Health Research and Application Center Gazi Hospital-Oncology ( Site 2502)
      • Ankara, Turkey (Türkiye), 06800
        • Ankara Bilkent Sehir Hastanesi ( Site 2503)
      • Istanbul, Turkey (Türkiye), 34722
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2506)
    • İzmir
      • Bornova, İzmir, Turkey (Türkiye), 35100
        • Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2501)
  • United Kingdom
    • England
      • Torquay, England, United Kingdom, TQ2 7AA
        • Torbay Hospital ( Site 2100)
      • Truro, England, United Kingdom, TR1 3LJ
        • The Royal Cornwall Hospital ( Site 2102)
  • United States
    • California
      • Fullerton, California, United States, 92835
        • Providence Medical Foundation ( Site 0117)
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Illinois Cancer Care ( Site 0101)
    • New York
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center ( Site 0104)
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center ( Site 0112)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
  • Received prior systemic anticancer therapy for their metastatic NSCLC.
  • Known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Pembrolizumab
"Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course,
Biological: Pembrolizumab
Administered intravenously on Day 1 of each cycle
Other Names:
  • MK-3475
  • SCH 900475
  • KEYTRUDA®
Experimental: Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab (+) Berahyaluronidase alfa SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.
Biological: Pembrolizumab (+) Berahyaluronidase alfa
Administered subcutaneously on Day 1 of each cycle
Other Names:
  • MK-3475A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose
Time Frame: At designated time points (up to approximately 14 months)
AUC is defined as area under curve exposure. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
At designated time points (up to approximately 14 months)
Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State
Time Frame: At designated time points (Up to ~15 months)
Ctrough is defined as the trough concentration at steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough
At designated time points (Up to ~15 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an AE- All Participants
Time Frame: Up to approximately 28 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Up to approximately 28 months
Number of Participants Who Discontinue Study Intervention Due to an AE
Time Frame: Up to approximately 25 months
An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Up to approximately 25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp and Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2024

Primary Completion (Actual)

March 12, 2026

Study Completion (Estimated)

April 17, 2027

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 18, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Actual)

July 21, 2026

Last Update Submitted That Met QC Criteria

July 20, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3475A-F84
  • MK-3475A-F84 (Other Identifier: MSD)
  • U1111-1306-1214 (Registry Identifier: UTN)
  • jRCT2031240445 (Registry Identifier: Japan Registry of Clinical Trials)
  • 2024-513165-39-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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