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

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

NCT ID: NCT05722015

Condition: Metastatic Non-small Cell Lung Cancer

Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Pembrolizumab
Pemetrexed
Lenograstim

Study type: Interventional

Study phase: Phase 3

Overall status: Active, not recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Biological
Intervention name: Pembrolizumab coformulated with hyaluronidase
Description: MK3475A SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may be eligible for second course.
Arm group label: Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)

Other name: MK-3475A

Intervention type: Drug
Intervention name: Pemetrexed
Description: Pemetrexed 500 mg/m² by IV Infusion will be administered for nonsquamous NSCLC as per the schedule specified in arm.
Arm group label: Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label: Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)

Other name: Alimta

Intervention type: Drug
Intervention name: Cisplatin
Description: Cisplatin 75 mg/m² by IV Infusion will be administered for nonsquamous and squamous NSCLC as per the schedule specified in arm.
Arm group label: Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label: Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)

Other name: Platinol-AQ

Intervention type: Drug
Intervention name: Carboplatin
Description: 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.
Arm group label: Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label: Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)

Intervention type: Drug
Intervention name: Paclitaxel
Description: Paclitaxel 200 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.
Arm group label: Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label: Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)

Other name: Taxol

Intervention type: Drug
Intervention name: Nab-paclitaxel
Description: Nab-paclitaxel 100 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.
Arm group label: Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label: Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)

Other name: Albumin-bound paclitaxel

Intervention type: Biological
Intervention name: Pembrolizumab
Description: 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.
Arm group label: Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)

Other name: MK-3475, KEYTRUDA

Intervention type: Drug
Intervention name: Filgrastim
Description: Filgrastim will be administered as per the schedule specified for the arm.
Arm group label: Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label: Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)

Intervention type: Drug
Intervention name: Pegylated filgrastim
Description: Pegylated filgrastim will be administered as per the schedule specified for the arm.
Arm group label: Arm 1 (MK-3475A + Platinum Doublet Chemotherapy)
Arm group label: Arm 2 (Pembrolizumab + Platinum Doublet Chemotherapy)

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

Criteria for eligibility:
Criteria:
The key inclusion and exclusion criteria include but are not limited to the following: 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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

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

Address:
City: Phoenix
Zip: 85004
Country: United States

Facility:
Name: Clermont Oncology Center ( Site 0018)

Address:
City: Clermont
Zip: 34711
Country: United States

Facility:
Name: Mid Florida Hematology and Oncology Center ( Site 0010)

Address:
City: Orange City
Zip: 32763
Country: United States

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

Address:
City: Chicago
Zip: 60612
Country: United States

Facility:
Name: Orchard Healthcare Research Inc. ( Site 0011)

Address:
City: Skokie
Zip: 60077
Country: United States

Facility:
Name: Franciscan Health Lafayette East ( Site 0020)

Address:
City: Lafayette
Zip: 47905
Country: United States

Facility:
Name: Mercy Health-Paducah Medical Oncology and Hematology ( Site 0006)

Address:
City: Paducah
Zip: 42003
Country: United States

Facility:
Name: Hattiesburg Clinic Hematology/Oncology ( Site 0008)

Address:
City: Hattiesburg
Zip: 39401
Country: United States

Facility:
Name: Central Care Cancer Center - Bolivar ( Site 0017)

Address:
City: Bolivar
Zip: 65613
Country: United States

Facility:
Name: Instituto Alexander Fleming ( Site 1008)

Address:
City: Ciudad Autónoma de Buenos Aires
Zip: C1426ANZ
Country: Argentina

Facility:
Name: Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001)

Address:
City: Mar del Plata
Zip: B7600FZO
Country: Argentina

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

Address:
City: ABB
Zip: C1199ABB
Country: Argentina

Facility:
Name: Sanatorio Parque ( Site 1003)

Address:
City: Rosario
Zip: S2000DSV
Country: Argentina

Facility:
Name: Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002)

Address:
City: Buenos Aires
Zip: C1122AAL
Country: Argentina

Facility:
Name: Clinica Adventista Belgrano-Oncology ( Site 1004)

Address:
City: Caba
Zip: C1430EGF
Country: Argentina

Facility:
Name: Hospital Italiano de Córdoba ( Site 1000)

Address:
City: Cordoba
Zip: 5000
Country: Argentina

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

Address:
City: Fortaleza
Zip: 60336232
Country: Brazil

Facility:
Name: Hospital de Câncer de Recife ( Site 1107)

Address:
City: Recife
Zip: 50040-000
Country: Brazil

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

Address:
City: Porto Alegre
Zip: 91350-200
Country: Brazil

Facility:
Name: Instituto Joinvilense de Hematologia e Oncologia ( Site 1101)

Address:
City: Joinville
Zip: 89201260
Country: Brazil

Facility:
Name: A. C. Camargo Cancer Center ( Site 1106)

Address:
City: Sao Paulo
Zip: 01509-010
Country: Brazil

Facility:
Name: IC La Serena Research ( Site 1207)

Address:
City: La Serena
Zip: 1720430
Country: Chile

Facility:
Name: Oncocentro Valdivia ( Site 1201)

Address:
City: Valdivia
Zip: 5112129
Country: Chile

Facility:
Name: FALP-UIDO ( Site 1203)

Address:
City: Santiago
Zip: 7500921
Country: Chile

Facility:
Name: Oncovida ( Site 1209)

Address:
City: Santiago
Zip: 7510032
Country: Chile

Facility:
Name: Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210)

Address:
City: Santiago
Zip: 8330032
Country: Chile

Facility:
Name: Instituto Nacional del Cancer-CR Investigación ( Site 1211)

Address:
City: Santiago
Zip: 8380455
Country: Chile

Facility:
Name: Bradfordhill-Clinical Area ( Site 1202)

Address:
City: Santiago
Zip: 8420383
Country: Chile

Facility:
Name: Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503)

Address:
City: Hefei
Zip: 230071
Country: China

Facility:
Name: Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510)

Address:
City: Beijing
Zip: 100142
Country: China

Facility:
Name: Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501)

Address:
City: Beijing
Zip: 100730
Country: China

Facility:
Name: Beijing Chest Hospital,Capital Medical University ( Site 4511)

Address:
City: Beijing
Zip: 101149
Country: China

Facility:
Name: Chongqing Three Gorges Central Hospital ( Site 4516)

Address:
City: Wanzhou
Zip: 404199
Country: China

Facility:
Name: Fujian Provincial Cancer Hospital ( Site 4517)

Address:
City: Fuzhou
Zip: 350014
Country: China

Facility:
Name: Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine (

Address:
City: Guangzhou
Zip: 510515
Country: China

Facility:
Name: Jiangmen Center Hospital ( Site 4509)

Address:
City: Jiangmen
Zip: 529030
Country: China

Facility:
Name: ShenZhen People's Hospital ( Site 4504)

Address:
City: Shenzhen
Zip: 518020
Country: China

Facility:
Name: Wuhan Union Hospital Cancer Center-Cancer center ( Site 4502)

Address:
City: Wuhan
Zip: 430022
Country: China

Facility:
Name: The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515)

Address:
City: Nanchang
Zip: 330006
Country: China

Facility:
Name: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520)

Address:
City: Xi'an
Zip: 710061
Country: China

Facility:
Name: Fudan University Shanghai Cancer Center-Oncology ( Site 4512)

Address:
City: Shanghai
Zip: 200032
Country: China

Facility:
Name: Shanxi Cancer Hospital ( Site 4521)

Address:
City: Taiyuan
Zip: 030000
Country: China

Facility:
Name: Tianjin Chest Hospital ( Site 4518)

Address:
City: Tianjin
Zip: 300051
Country: China

Facility:
Name: The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514)

Address:
City: Hangzhou
Zip: 310006
Country: China

Facility:
Name: Taizhou Hospital of Zhejiang Province-Respiratory ( Site 4508)

Address:
City: Taizhou
Zip: 317000
Country: China

Facility:
Name: Centre Hospitalier de Cornouaille Quimper - Concarneau ( Site 2600)

Address:
City: Quimper
Zip: 29107
Country: France

Facility:
Name: Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 2602)

Address:
City: Tours
Zip: 37044
Country: France

Facility:
Name: Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 2603)

Address:
City: Paris
Zip: 75014
Country: France

Facility:
Name: Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404)

Address:
City: Ciudad de Guatemala
Zip: 01010
Country: Guatemala

Facility:
Name: MEDI-K CAYALA ( Site 1403)

Address:
City: Guatemala
Zip: 01016
Country: Guatemala

Facility:
Name: Centro Regional de Sub Especialidades Médicas SA ( Site 1401)

Address:
City: Quetzaltenango
Zip: 09001
Country: Guatemala

Facility:
Name: Centro Medico Integral De Cancerología (CEMIC) ( Site 1400)

Address:
City: Quetzaltenango
Zip: 09002
Country: Guatemala

Facility:
Name: Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2102)

Address:
City: Kecskemét
Zip: 6000
Country: Hungary

Facility:
Name: Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2103)

Address:
City: Szolnok
Zip: 5000
Country: Hungary

Facility:
Name: Törökbálinti Tüdőgyógyintézet ( Site 2105)

Address:
City: Törökbálint
Zip: 2045
Country: Hungary

Facility:
Name: Semmelweis Egyetem-Pulmonológiai Klinika ( Site 2104)

Address:
City: Budapest
Zip: 1083
Country: Hungary

Facility:
Name: Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2100)

Address:
City: Budapest
Zip: 1121
Country: Hungary

Facility:
Name: Fujita Health University ( Site 4406)

Address:
City: Toyoake
Zip: 470-1192
Country: Japan

Facility:
Name: Kurume University Hospital ( Site 4412)

Address:
City: Kurume
Zip: 830-0011
Country: Japan

Facility:
Name: Gunma Prefectural Cancer Center ( Site 4416)

Address:
City: Otashi
Zip: 373-8550
Country: Japan

Facility:
Name: National Hospital Organization Hokkaido Cancer Center ( Site 4415)

Address:
City: Sapporo
Zip: 003-0804
Country: Japan

Facility:
Name: Kanagawa Cardiovascular and Respiratory Center ( Site 4404)

Address:
City: Yokohama
Zip: 236-0051
Country: Japan

Facility:
Name: Miyagi Cancer Center ( Site 4401)

Address:
City: Natori
Zip: 981-1293
Country: Japan

Facility:
Name: Sendai Kousei Hospital ( Site 4400)

Address:
City: Sendai
Zip: 9800873
Country: Japan

Facility:
Name: Kurashiki Central Hospital ( Site 4409)

Address:
City: Kurashiki
Zip: 710-8602
Country: Japan

Facility:
Name: Kansai Medical University Hospital ( Site 4408)

Address:
City: Hirakata
Zip: 573-1191
Country: Japan

Facility:
Name: Osaka Medical and Pharmaceutical University Hospital ( Site 4414)

Address:
City: Takatsuki
Zip: 569-8686
Country: Japan

Facility:
Name: Saitama Prefectural Cancer Center ( Site 4402)

Address:
City: Ina-machi
Zip: 362-0806
Country: Japan

Facility:
Name: Shizuoka Cancer Center ( Site 4405)

Address:
City: Nagaizumi-cho,Sunto-gun
Zip: 411-8777
Country: Japan

Facility:
Name: Tochigi Cancer Center ( Site 4417)

Address:
City: Utsunomiya
Zip: 320-0834
Country: Japan

Facility:
Name: Juntendo University Hospital ( Site 4413)

Address:
City: Bunkyo-ku
Zip: 1138431
Country: Japan

Facility:
Name: National Hospital Organization Kyushu Medical Center ( Site 4411)

Address:
City: Fukuoka
Zip: 810-8563
Country: Japan

Facility:
Name: National Hospital Organization Kyushu Cancer Center ( Site 4410)

Address:
City: Fukuoka
Zip: 811-1395
Country: Japan

Facility:
Name: Osaka International Cancer Institute ( Site 4407)

Address:
City: Osaka
Zip: 541-8567
Country: Japan

Facility:
Name: Nippon Medical School Hospital ( Site 4403)

Address:
City: Tokyo
Zip: 113-8603
Country: Japan

Facility:
Name: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier

Address:
City: Warszawa
Zip: 02-781
Country: Poland

Facility:
Name: Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii

Address:
City: Olsztyn
Zip: 10-357
Country: Poland

Facility:
Name: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2801)

Address:
City: Koszalin
Zip: 75-581
Country: Poland

Facility:
Name: SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2303)

Address:
City: Florești
Zip: 407280
Country: Romania

Facility:
Name: Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2301)

Address:
City: Craiova
Zip: 200542
Country: Romania

Facility:
Name: Cabinet Medical Oncomed ( Site 2305)

Address:
City: Timișoara
Zip: 300239
Country: Romania

Facility:
Name: Institutul Oncologic-Oncologie Medicala ( Site 2302)

Address:
City: Cluj
Zip: 400015
Country: Romania

Facility:
Name: CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903)

Address:
City: Port Elizabeth
Zip: 6055
Country: South Africa

Facility:
Name: Medical Oncology Centre of Rosebank ( Site 2907)

Address:
City: Johannesburg
Zip: 2196
Country: South Africa

Facility:
Name: Steve Biko Academic Hospital-Medical Oncology ( Site 2904)

Address:
City: Pretoria
Zip: 0001
Country: South Africa

Facility:
Name: Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900)

Address:
City: Sandton
Zip: 2196
Country: South Africa

Facility:
Name: The Oncology Centre ( Site 2901)

Address:
City: Durban
Zip: 4091
Country: South Africa

Facility:
Name: Cape Town Oncology Trials ( Site 2902)

Address:
City: Cape Town
Zip: 7570
Country: South Africa

Facility:
Name: CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2404)

Address:
City: Santiago de Compostela
Zip: 15706
Country: Spain

Facility:
Name: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2401)

Address:
City: Madrid
Zip: 28009
Country: Spain

Facility:
Name: Hospital Universitari Vall d'Hebron-Oncology ( Site 2400)

Address:
City: Barcelona
Zip: 08035
Country: Spain

Facility:
Name: Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2402)

Address:
City: Huelva
Zip: 21005
Country: Spain

Facility:
Name: Changhua Christian Hospital ( Site 4203)

Address:
City: Changhua County
Zip: 50006
Country: Taiwan

Facility:
Name: Chang Gung Memorial Hospital at Kaohsiung ( Site 4200)

Address:
City: Kaohsiung Niao Sung Dist
Zip: 83301
Country: Taiwan

Facility:
Name: National Taiwan University Cancer Center (NTUCC) ( Site 4205)

Address:
City: Taipei City
Zip: 106
Country: Taiwan

Facility:
Name: Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207)

Address:
City: Kaohsiung
Zip: 807
Country: Taiwan

Facility:
Name: E-Da hospital ( Site 4208)

Address:
City: Kaohsiung
Zip: 82445
Country: Taiwan

Facility:
Name: National Cheng Kung University Hospital ( Site 4202)

Address:
City: Tainan
Zip: 704
Country: Taiwan

Facility:
Name: National Taiwan University Hospital-Oncology ( Site 4204)

Address:
City: Taipei
Zip: 10002
Country: Taiwan

Facility:
Name: Maharaj Nakorn Chiang Mai Hospital ( Site 4300)

Address:
City: Muang
Zip: 50200
Country: Thailand

Facility:
Name: Chulalongkorn University ( Site 4301)

Address:
City: Bangkok
Zip: 10330
Country: Thailand

Facility:
Name: Division of Medical Oncology, Siriraj H ( Site 4303)

Address:
City: Siriraj
Zip: 10700
Country: Thailand

Facility:
Name: Songklanagarind hospital ( Site 4302)

Address:
City: Hatyai
Zip: 90110
Country: Thailand

Facility:
Name: I.E.U. Medical Point Hastanesi-Oncology ( Site 2507)

Address:
City: Izmir, Karsiyaka
Zip: 009035575
Country: Turkey

Facility:
Name: Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504)

Address:
City: Ankara
Zip: 06010
Country: Turkey

Facility:
Name: Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506)

Address:
City: Ankara
Zip: 06230
Country: Turkey

Facility:
Name: Ankara City Hospital-Medical Oncology ( Site 2501)

Address:
City: Ankara
Zip: 06800
Country: Turkey

Facility:
Name: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)

Address:
City: Istanbul
Zip: 34722
Country: Turkey

Facility:
Name: Memorial Kayseri Hastanesi ( Site 2500)

Address:
City: Kayseri
Zip: 38010
Country: Turkey

Facility:
Name: İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503)

Address:
City: Malatya
Zip: 44280
Country: Turkey

Start date: February 14, 2023

Completion date: May 22, 2028

Lead sponsor:
Agency: Merck Sharp & Dohme LLC
Agency class: Industry

Source: Merck Sharp & Dohme LLC

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05722015
https://www.merckclinicaltrials.com/
https://trialstransparency.merckclinicaltrials.com/Study.aspx?id=3475A-D77&&kw=3475A-D77