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NCT05722015

PHASE3

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.

Official title: 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, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

377

Start Date

2023-02-14

Completion Date

2028-05-22

Last Updated

2025-09-11

Healthy Volunteers

Conditions

Metastatic Non-small Cell Lung Cancer

Interventions

BIOLOGICAL

Pembrolizumab Formulated with 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.

DRUG

Pemetrexed

Pemetrexed 500 mg/m² by IV Infusion will be administered for nonsquamous NSCLC as per the schedule specified in arm.

DRUG

Cisplatin

Cisplatin 75 mg/m² by IV Infusion will be administered for nonsquamous and squamous NSCLC as per the schedule specified in arm.

DRUG

Carboplatin

Carboplatin AUC 5 mg/mL/min in nonsquamous and AUC 6 mg/mL/min in squamous NSCLC will be administered as per the schedule specified in arm.

DRUG

Paclitaxel

Paclitaxel 200 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.

DRUG

Nab-paclitaxel

Nab-paclitaxel 100 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.

BIOLOGICAL

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.

DRUG

Filgrastim

Filgrastim will be administered as per the schedule specified for the arm.

DRUG

Pegylated filgrastim

Pegylated filgrastim will be administered as per the schedule specified for the arm.

Locations (110)

St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023)

Phoenix, Arizona, United States

Clermont Oncology Center ( Site 0018)

Clermont, Florida, United States

Mid Florida Hematology and Oncology Center ( Site 0010)

Orange City, Florida, United States

University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022)

Chicago, Illinois, United States

Orchard Healthcare Research Inc. ( Site 0011)

Skokie, Illinois, United States

Franciscan Health Lafayette East ( Site 0020)

Lafayette, Indiana, United States

Mercy Health-Paducah Cancer Center ( Site 0006)

Paducah, Kentucky, United States

Hattiesburg Clinic Hematology/Oncology ( Site 0008)

Hattiesburg, Mississippi, United States

Central Care Cancer Center - Bolivar ( Site 0017)

Bolivar, Missouri, United States

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001)

Mar del Plata, Buenos Aires, Argentina

Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002)

Buenos Aires, Buenos Aires F.D., Argentina

Instituto Alexander Fleming ( Site 1008)

Buenos Aires, Buenos Aires F.D., Argentina

Clinica Adventista Belgrano-Oncology ( Site 1004)

Buenos Aires, Buenos Aires F.D., Argentina

Sanatorio Parque ( Site 1003)

Rosario, Santa Fe Province, Argentina

Hospital Italiano de Córdoba ( Site 1000)

Córdoba, Argentina

CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102)

Fortaleza, Ceará, Brazil

Hospital de Cancer de Pernambuco ( Site 1107)

Recife, Pernambuco, Brazil

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1100)

Porto Alegre, Rio Grande do Sul, Brazil

Instituto Joinvilense de Hematologia e Oncologia ( Site 1101)

Joinville, Santa Catarina, Brazil

A. C. Camargo Cancer Center ( Site 1106)

São Paulo, Brazil

IC La Serena Research ( Site 1207)

La Serena, Coquimbo Region, Chile

Oncocentro Valdivia ( Site 1201)

Valdivia, Los Ríos Region, Chile

FALP-UIDO ( Site 1203)