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A Study of Subcutaneous (SC) ...

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)

NCT ID: NCT05722015

Last Updated: 2025-09-11

Study Results

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Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

377 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-14

Study Completion Date

2028-05-22

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy

Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.

Group Type EXPERIMENTAL

Pembrolizumab Formulated with Berahyaluronidase Alfa

Intervention Type BIOLOGICAL

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.

Pemetrexed

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

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.

Paclitaxel

Intervention Type DRUG

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

Nab-paclitaxel

Intervention Type DRUG

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

Filgrastim

Intervention Type DRUG

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

Pegylated filgrastim

Intervention Type DRUG

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

Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy.

Group Type ACTIVE_COMPARATOR

Pemetrexed

Intervention Type DRUG

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

Cisplatin

Intervention Type DRUG

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

Carboplatin

Intervention Type DRUG

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.

Paclitaxel

Intervention Type DRUG

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

Nab-paclitaxel

Intervention Type DRUG

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

Pembrolizumab

Intervention Type BIOLOGICAL

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.

Filgrastim

Intervention Type DRUG

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

Pegylated filgrastim

Intervention Type DRUG

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

Interventions

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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.

Intervention Type BIOLOGICAL

Pemetrexed

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

Intervention Type DRUG

Cisplatin

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

Intervention Type 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.

Intervention Type DRUG

Paclitaxel

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

Intervention Type DRUG

Nab-paclitaxel

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

Intervention Type DRUG

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.

Intervention Type BIOLOGICAL

Filgrastim

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

Intervention Type DRUG

Pegylated filgrastim

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

Intervention Type DRUG

Other Intervention Names

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MK-3475A Alimta Platinol-AQ Taxol Albumin-bound paclitaxel MK-3475, KEYTRUDA

Eligibility Criteria

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Inclusion Criteria

* Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC)
* Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
* Has a life expectancy of at least 3 months

Exclusion Criteria

* Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
* Has received prior systemic anticancer therapy for metastatic NSCLC
* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
* Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids
* Has received radiation therapy to the lung (\>30 Gray) within 6 months of start of study intervention
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has an active infection requiring systemic therapy
* Has a history of human immunodeficiency virus (HIV) infection
* Has a history of Hepatitis B or C
* Has not adequately recovered from major surgery or has ongoing surgical complications
* Has a history of allogenic tissue/solid organ transplant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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

Phoenix, Arizona, United States

Site Status

Clermont Oncology Center ( Site 0018)

Clermont, Florida, United States

Site Status

Mid Florida Hematology and Oncology Center ( Site 0010)

Orange City, Florida, United States

Site Status

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

Chicago, Illinois, United States

Site Status

Orchard Healthcare Research Inc. ( Site 0011)

Skokie, Illinois, United States

Site Status

Franciscan Health Lafayette East ( Site 0020)

Lafayette, Indiana, United States

Site Status

Mercy Health-Paducah Cancer Center ( Site 0006)

Paducah, Kentucky, United States

Site Status

Hattiesburg Clinic Hematology/Oncology ( Site 0008)

Hattiesburg, Mississippi, United States

Site Status

Central Care Cancer Center - Bolivar ( Site 0017)

Bolivar, Missouri, United States

Site Status

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

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site Status

Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001)

Mar del Plata, Buenos Aires, Argentina

Site Status

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

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Instituto Alexander Fleming ( Site 1008)

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Clinica Adventista Belgrano-Oncology ( Site 1004)

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Sanatorio Parque ( Site 1003)

Rosario, Santa Fe Province, Argentina

Site Status

Hospital Italiano de Córdoba ( Site 1000)

Córdoba, , Argentina

Site Status

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

Fortaleza, Ceará, Brazil

Site Status

Hospital de Cancer de Pernambuco ( Site 1107)

Recife, Pernambuco, Brazil

Site Status

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

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Instituto Joinvilense de Hematologia e Oncologia ( Site 1101)

Joinville, Santa Catarina, Brazil

Site Status

A. C. Camargo Cancer Center ( Site 1106)

São Paulo, , Brazil

Site Status

IC La Serena Research ( Site 1207)

La Serena, Coquimbo Region, Chile

Site Status