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

NCT06698042 | Active Not Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: 3475A-F84MK-3475A-F842024-513165-39-00U1111-1306-1214jRCT2031240445
• Study Type: interventional
• Target: 67
• Locations: 12 countries
• Sites: 67

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

Conditions

Lung Cancer; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose

  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

  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 Outcomes (2)

• Number of Participants Who Experience an AE- All Participants

  Up to approximately 28 months

• Number of Participants Who Discontinue Study Intervention Due to an AE

  Up to approximately 25 months

Study Arms (2)

Pembrolizumab (+) Berahyaluronidase alfa

EXPERIMENTAL

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

Pembrolizumab

ACTIVE COMPARATOR

"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

Interventions

Pembrolizumab BIOLOGICAL

Administered intravenously on Day 1 of each cycle

Also known as: MK-3475, KEYTRUDA®, SCH 900475

Pembrolizumab

Pembrolizumab (+) Berahyaluronidase alfa BIOLOGICAL

Administered subcutaneously on Day 1 of each cycle

Also known as: MK-3475A

Pembrolizumab (+) Berahyaluronidase alfa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (67)

Providence Medical Foundation ( Site 0117)

Fullerton, California, 92835, United States

Location

Illinois Cancer Care ( Site 0101)

Peoria, Illinois, 61615, United States

Location

Montefiore Medical Center ( Site 0104)

The Bronx, New York, 10461, United States

Location

University of Cincinnati Medical Center ( Site 0112)

Cincinnati, Ohio, 45219, United States

Location

Beijing Peking Union Medical College Hospital ( Site 5000)

Beijing, Beijing Municipality, 100730, China

Location

Chongqing University Three Gorges Hospital ( Site 5018)

Chongqing, Chongqing Municipality, 404000, China

Location

Fujian Province Cancer Hospital ( Site 5007)

Fuzhou, Fujian, 350014, China

Location

The First Affiliated hospital of Xiamen University ( Site 5008)

Xiamen, Fujian, 361003, China

Location

The first affiliated hospital, Sun Yat-Sen university ( Site 5011)

Guangzhou, Guangdong, 510080, China

Location

Southern Medical University Nanfang Hospital ( Site 5003)

Guangzhou, Guangdong, 510515, China

Location

Huizhou Central People's Hospital ( Site 5004)

Huizhou, Guangdong, 516001, China

Location

Jiangmen Center Hospital ( Site 5001)

Jiangmen, Guangdong, 529030, China

Location

Liuzhou People's Hospital ( Site 5009)

Liuchow, Guangxi, 545006, China

Location

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

Wuhan, Hubei, 430048, China

Location

The First Affiliated Hospital of Nanchang University ( Site 5019)

Nanchang, Jiangxi, 330006, China

Location

Jilin Province Tumor Hospital ( Site 5014)

Changchun, Jilin, 130000, China

Location

Jinan Central Hospital ( Site 5012)

Jinan, Shandong, 250013, China

Location

Shanghai Pulmonary Hospital ( Site 5010)

Shanghai, Shanghai Municipality, 200433, China

Location

West China Hospital of Sichuan University ( Site 5016)

Chengdu, Sichuan, 610041, China

Location

Sichuan Cancer Hospital. ( Site 5006)

Chengdu, Sichuan, 610213, China

Location

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

Hangzhou, Zhejiang, 310016, China

Location

Taizhou Hospital of Zhejiang Province ( Site 5002)

Linhai, Zhejiang, 317000, China

Location

HELIOS Klinikum Erfurt ( Site 2005)

Erfurt, Thuringia, 99089, Germany

Location

Universitätsklinikum Jena ( Site 2002)

Jena, Thuringia, 07747, Germany

Location

MEDI-K ( Site 1101)

Guatemala City, 01009, Guatemala

Location

CELAN,S.A ( Site 1104)

Guatemala City, 01010, Guatemala

Location

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

Guatemala City, 01010, Guatemala

Location

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

Quetzaltenango, 09002, Guatemala

Location

Fujita Health University Hospital ( Site 4004)

Toyoake, Aichi-ken, 470-1192, Japan

Location

Ehime University Hospital ( Site 4007)

Tōon, Ehime, 791-0295, Japan

Location

Hospital of the University of Occupational and Environmental Health, Japan ( Site 4010)

Kitakyushu, Fukuoka, 807-8556, Japan

Location

Takarazuka City Hospital ( Site 4006)

Takarazuka, Hyōgo, 665-0827, Japan

Location

Kanagawa Cardiovascular and Respiratory Center ( Site 4002)

Yokohama, Kanagawa, 236-0051, Japan

Location

Kochi Medical School Hospital ( Site 4012)

Nankoku, Kochi, 783-8505, Japan

Location

Miyagi Cancer Center ( Site 4000)

Natori-shi, Miyagi, 981-1293, Japan

Location

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

Sakai, Osaka, 591-8555, Japan

Location

Saitama Prefectural Cancer Center ( Site 4001)

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

Tochigi Cancer Center ( Site 4008)

Utsunomiya, Tochigi, 320-0834, Japan

Location

Juntendo University Hospital ( Site 4003)

Bunkyo, Tokyo, 113-8431, Japan

Location

Fukushima Medical University Hospital ( Site 4011)

Fukushima, 960-1295, Japan

Location

Osaka International Cancer Institute ( Site 4005)

Osaka, 541-8567, Japan

Location

Clínica San Antonio ( Site 1006)

Trujillo, La Libertad, 13008, Peru

Location

Clínica Internacional - Sede San Borja ( Site 1002)

Lima, 15036, Peru

Location

IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1004)

Lima, 15036, Peru

Location

Oncosalud ( Site 1000)

Lima, 15036, Peru

Location

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

Siedlce, Masovian Voivodeship, 08-110, Poland

Location

Narodowy Instytut Onkologii ( Site 2303)

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

SC Radiotherapy Center Cluj SRL ( Site 2203)

Floreşti, Cluj, 407280, Romania

Location

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

Craiova, Dolj, 200746, Romania

Location

Spitalul Municipal Schuller Ploiești ( Site 2204)

Ploieşti, Prahova, 100337, Romania

Location

Institutul Oncologic ( Site 2202)

Cluj-Napoca, 400015, Romania

Location

Pusan National University Hospital ( Site 3002)

Pusan Kwangyokshi, Pusan-Kwangyokshi, 49241, South Korea

Location

Chungnam National University Hospital ( Site 3003)

Daejeon, Taejon-Kwangyokshi, 35015, South Korea

Location

Korea University Guro Hospital ( Site 3001)

Seoul, 08308, South Korea

Location

Onkologikoa - Instituto Oncologico de San Sebastian ( Site 2454)

Donostia / San Sebastian, Gipuzkoa, 20014, Spain

Location

Hospital General Universitari Vall d Hebron ( Site 2450)

Barcelona, 08035, Spain

Location

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

Barcelona, 08908, Spain

Location

Hospital Universitario Juan Ramon Jimenez ( Site 2453)

Huelva, 21005, Spain

Location

Hospital Universitario Virgen Macarena ( Site 2455)

Seville, 41009, Spain

Location

Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2501)

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

Gulhane Egitim Arastirma Hastanesi ( Site 2504)

Ankara, 06010, Turkey (Türkiye)

Location

Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)

Ankara, 06230, Turkey (Türkiye)

Location

Gazi University Health Research and Application Center Gazi Hospital-Oncology ( Site 2502)

Ankara, 06560, Turkey (Türkiye)

Location

Ankara Bilkent Sehir Hastanesi ( Site 2503)

Ankara, 06800, Turkey (Türkiye)

Location

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2506)

Istanbul, 34722, Turkey (Türkiye)

Location

Torbay Hospital ( Site 2100)

Torquay, England, TQ2 7AA, United Kingdom

Location

The Royal Cornwall Hospital ( Site 2102)

Truro, England, TR1 3LJ, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Medical Director

  Merck Sharp and Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: November 21, 2024
• Primary Completion: March 12, 2026
• Study Completion (Estimated): February 11, 2030
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (2); ES (5); PL (2); GU (4); JP (13); DE (2); PE (4); KR (3); RO (4); CN (18); TU (6); US (4)