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

Running, not enrolling · Phase 3

Conditions studied: Lung Cancer, Non-Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT06698042

Run by

Merck Sharp & Dohme LLC

People needed

67

Starts

2024-11-21

Expected to finish

2027-04-17

Last updated by the study team

2026-07-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Illinois Cancer Care ( Site 0101) — Peoria, Illinois, United States
• Montefiore Medical Center ( Site 0104) — The Bronx, New York, United States
• University of Cincinnati Medical Center ( Site 0112) — Cincinnati, Ohio, United States
• Beijing Peking Union Medical College Hospital ( Site 5000) — Beijing, Beijing Municipality, China
• Chongqing University Three Gorges Hospital ( Site 5018) — Chongqing, Chongqing Municipality, China
• Fujian Province Cancer Hospital ( Site 5007) — Fuzhou, Fujian, China
• The First Affiliated hospital of Xiamen University ( Site 5008) — Xiamen, Fujian, China
• The first affiliated hospital, Sun Yat-Sen university ( Site 5011) — Guangzhou, Guangdong, China
• Southern Medical University Nanfang Hospital ( Site 5003) — Guangzhou, Guangdong, China
• Huizhou Central People's Hospital ( Site 5004) — Huizhou, Guangdong, China
• Jiangmen Center Hospital ( Site 5001) — Jiangmen, Guangdong, China
• Liuzhou People's Hospital ( Site 5009) — Liuzhou, Guangxi, China
• Wuhan Union Hospital Cancer Center-Cancer Center ( Site 5015) — Wuhan, Hubei, China
• The First Affiliated Hospital of Nanchang University ( Site 5019) — Nanchang, Jiangxi, China
• Jilin Province Tumor Hospital ( Site 5014) — Changchun, Jilin, China
• Jinan Central Hospital ( Site 5012) — Jinan, Shandong, China
• Shanghai Pulmonary Hospital ( Site 5010) — Shanghai, Shanghai Municipality, China
• West China Hospital of Sichuan University ( Site 5016) — Chengdu, Sichuan, China
• Sichuan Cancer Hospital. ( Site 5006) — Chengdu, Sichuan, China
• Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5021) — Hangzhou, Zhejiang, China
• Taizhou Hospital of Zhejiang Province ( Site 5002) — Linhai, Zhejiang, China
• HELIOS Klinikum Erfurt ( Site 2005) — Erfurt, Thuringia, Germany
• Universitätsklinikum Jena ( Site 2002) — Jena, Thuringia, Germany
• MEDI-K ( Site 1101) — Guatemala City, Guatemala
• Providence Medical Foundation ( Site 0117) — Fullerton, California, United States

Full record on ClinicalTrials.gov

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