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

NCT06698042 · tracked via the Priya Life Science UK tracker

Sponsor

Merck Sharp & Dohme LLC

Phase

Phase 3

Started

2024-11-21

Last updated

2026-07-21

Condition(s) studied

Lung CancerNon-Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

Pembrolizumab (+) Berahyaluronidase alfaPembrolizumab

Pembrolizumab (+) Berahyaluronidase alfa: Administered subcutaneously on Day 1 of each cycle

Pembrolizumab: Administered intravenously on Day 1 of each cycle

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose — 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.
Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State — 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

Trial sites (67)

Facility	City	Region
Providence Medical Foundation ( Site 0117)	Fullerton	California
Illinois Cancer Care ( Site 0101)	Peoria	Illinois
Montefiore Medical Center ( Site 0104)	The Bronx	New York
University of Cincinnati Medical Center ( Site 0112)	Cincinnati	Ohio
Beijing Peking Union Medical College Hospital ( Site 5000)	Beijing	Beijing Municipality
Chongqing University Three Gorges Hospital ( Site 5018)	Chongqing	Chongqing Municipality
Fujian Province Cancer Hospital ( Site 5007)	Fuzhou	Fujian
The First Affiliated hospital of Xiamen University ( Site 5008)	Xiamen	Fujian
The first affiliated hospital, Sun Yat-Sen university ( Site 5011)	Guangzhou	Guangdong
Southern Medical University Nanfang Hospital ( Site 5003)	Guangzhou	Guangdong
Huizhou Central People's Hospital ( Site 5004)	Huizhou	Guangdong
Jiangmen Center Hospital ( Site 5001)	Jiangmen	Guangdong
Liuzhou People's Hospital ( Site 5009)	Liuzhou	Guangxi
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 5015)	Wuhan	Hubei
The First Affiliated Hospital of Nanchang University ( Site 5019)	Nanchang	Jiangxi
Jilin Province Tumor Hospital ( Site 5014)	Changchun	Jilin
Jinan Central Hospital ( Site 5012)	Jinan	Shandong
Shanghai Pulmonary Hospital ( Site 5010)	Shanghai	Shanghai Municipality
West China Hospital of Sichuan University ( Site 5016)	Chengdu	Sichuan
Sichuan Cancer Hospital. ( Site 5006)	Chengdu	Sichuan
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5021)	Hangzhou	Zhejiang
Taizhou Hospital of Zhejiang Province ( Site 5002)	Linhai	Zhejiang
HELIOS Klinikum Erfurt ( Site 2005)	Erfurt	Thuringia
Universitätsklinikum Jena ( Site 2002)	Jena	Thuringia
MEDI-K ( Site 1101)	Guatemala City	Guatemala
CELAN,S.A ( Site 1104)	Guatemala City	Guatemala
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1102)	Guatemala City	Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 1103)	Quetzaltenango	Guatemala
Fujita Health University Hospital ( Site 4004)	Toyoake	Aichi-ken
Ehime University Hospital ( Site 4007)	Tōon	Ehime
Hospital of the University of Occupational and Environmental Health, Japan ( Site 4010)	Kitakyushu	Fukuoka
Takarazuka City Hospital ( Site 4006)	Takarazuka	Hyōgo
Kanagawa Cardiovascular and Respiratory Center ( Site 4002)	Yokohama	Kanagawa
Kochi Medical School Hospital ( Site 4012)	Nankoku	Kochi
Miyagi Cancer Center ( Site 4000)	Natori-shi	Miyagi
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 4009)	Sakai	Osaka
Saitama Prefectural Cancer Center ( Site 4001)	Kitaadachi-gun	Saitama
Tochigi Cancer Center ( Site 4008)	Utsunomiya	Tochigi
Juntendo University Hospital ( Site 4003)	Bunkyo	Tokyo
Fukushima Medical University Hospital ( Site 4011)	Fukushima	Japan

+ 27 more sites — see the full list on the official registry below.

On this site

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06698042 on ClinicalTrials.gov ↗ ← All trials in the UK