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A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)
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 RecruitingPhase 3

Sponsor: Merck Sharp & Dohme LLC

Conditions: Lung Cancer, Non-Small Cell Lung Cancer

Interventions: Pembrolizumab (+) Berahyaluronidase alfa, Pembrolizumab

Countries: United States, China, Germany, Guatemala, Japan, Peru, Poland, Romania

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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.
Locations (67)
  • Fullerton, California, United States
  • Peoria, Illinois, United States
  • The Bronx, New York, United States
  • Cincinnati, Ohio, United States
  • Beijing, Beijing Municipality, China
  • Chongqing, Chongqing Municipality, China
  • Fuzhou, Fujian, China
  • Xiamen, Fujian, China
  • Guangzhou, Guangdong, China
  • Guangzhou, Guangdong, China
  • Huizhou, Guangdong, China
  • Jiangmen, Guangdong, China
  • Liuzhou, Guangxi, China
  • Wuhan, Hubei, China
  • Nanchang, Jiangxi, China
  • Changchun, Jilin, China
  • Jinan, Shandong, China
  • Shanghai, Shanghai Municipality, China
  • Chengdu, Sichuan, China
  • Chengdu, Sichuan, China
  • Hangzhou, Zhejiang, China
  • Linhai, Zhejiang, China
  • Erfurt, Thuringia, Germany
  • Jena, Thuringia, Germany
  • Guatemala City, Guatemala
  • Guatemala City, Guatemala
  • Guatemala City, Guatemala
  • Quetzaltenango, Guatemala
  • Toyoake, Aichi-ken, Japan
  • Tōon, Ehime, Japan
  • + 37 more on CT.gov