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)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

377

Participants

Timeline

Start Date

February 14, 2023

Primary Completion Date

July 12, 2024

Study Completion Date

May 22, 2028

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.

Trial Locations (110)

106

National Taiwan University Cancer Center (NTUCC) ( Site 4205), Taipei City

704

National Cheng Kung University Hospital ( Site 4202), Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207), Kaohsiung City

1083

Semmelweis Egyetem-Pulmonológiai Klinika ( Site 2104), Budapest

1121

Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2100), Budapest

2045

Reformatus Pulmonologiai Centrum ( Site 2105), Törökbálint

2196

Medical Oncology Centre of Rosebank ( Site 2907), Johannesburg

Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900), Sandton

4091

The Oncology Centre ( Site 2901), Durban

5004

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2103), Szolnok

6000

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2102), Kecskemét

6055

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903), Port Elizabeth

7570

Cape Town Oncology Trials ( Site 2902), Cape Town

10002

National Taiwan University Hospital-Oncology ( Site 4204), Taipei

10330

Chulalongkorn University ( Site 4301), Bangkok

10700

Division of Medical Oncology, Siriraj H ( Site 4303), Bangkok

15706

CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2404), Santiago de Compostela

21005

Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2402), Huelva

28009

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2401), Madrid

29107

Centre Hospitalier de Cornouaille Quimper - Concarneau ( Site 2600), Quimper

32763

Mid Florida Hematology and Oncology Center ( Site 0010), Orange City

34711

Clermont Oncology Center ( Site 0018), Clermont

34722

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502), Istanbul

35575

I.E.U. Medical Point Hastanesi-Oncology ( Site 2507), Izmir

37000

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 2602), Tours

38010

Memorial Kayseri Hastanesi ( Site 2500), Kayseri

39401

Hattiesburg Clinic Hematology/Oncology ( Site 0008), Hattiesburg

42003

Mercy Health-Paducah Cancer Center ( Site 0006), Paducah

44280

İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503), Malatya

47905

Franciscan Health Lafayette East ( Site 0020), Lafayette

50006

Changhua Christian Hospital ( Site 4203), Changhua

50200

Maharaj Nakorn Chiang Mai Hospital ( Site 4300), Chiang Mai

60077

Orchard Healthcare Research Inc. ( Site 0011), Skokie

60612

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

65613

Central Care Cancer Center - Bolivar ( Site 0017), Bolivar

75014

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 2603), Paris

82445

E-Da hospital ( Site 4208), Kaohsiung City

83301

Chang Gung Memorial Hospital at Kaohsiung ( Site 4200), Kaohsiung City

85004

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

90110

Songklanagarind hospital ( Site 4302), Songkhla

100142

Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510), Beijing

100730

Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501), Beijing

101149

Beijing Chest Hospital,Capital Medical University ( Site 4511), Beijing

200032

Fudan University Shanghai Cancer Center-Oncology ( Site 4512), Shanghai

200542

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2301), Craiova

230071

Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503), Hefei

300051

Tianjin Chest Hospital ( Site 4518), Tianjin

300239

Cabinet Medical Oncomed ( Site 2305), Timișoara

310003

The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514), Hangzhou

317000

Taizhou Hospital of Zhejiang Province ( Site 4508), Linhai

330006

The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515), Nanchang

350014

Fujian Provincial Cancer Hospital ( Site 4517), Fuzhou

400015

Institutul Oncologic-Oncologie Medicala ( Site 2302), Cluj-Napoca

404199

Chongqing University Three Gorges Hospital ( Site 4516), Wanzhou

407280

SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2303), Florești

410013

Shanxi Cancer Hospital ( Site 4521), Taiyuan

430048

Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 4502), Wuhan

510515

Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 4519), Guangzhou

518020

ShenZhen People's Hospital ( Site 4504), Shenzhen

529030

Jiangmen Center Hospital ( Site 4509), Jiangmen

710061

The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520), Xi'an

1720430

IC La Serena Research ( Site 1207), La Serena

5112129

Oncocentro Valdivia ( Site 1201), Valdivia

7500921

FALP-UIDO ( Site 1203), Santiago

7500994

Oncovida ( Site 1209), Santiago

8330024

Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210), Santiago

8380455

Instituto Nacional del Cancer-CR Investigación ( Site 1211), Santiago

8420383

Bradfordhill-Clinical Area ( Site 1202), Santiago

C1199ABB

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

B7600FZO

Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001), Mar del Plata

C1122AAL

Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002), Buenos Aires

C1426ANZ

Instituto Alexander Fleming ( Site 1008), Buenos Aires

C1430EGF

Clinica Adventista Belgrano-Oncology ( Site 1004), Buenos Aires

S2000DVC

Sanatorio Parque ( Site 1003), Rosario

X5004BAL

Hospital Italiano de Córdoba ( Site 1000), Córdoba

60336-232

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

50040-000

Hospital de Cancer de Pernambuco ( Site 1107), Recife

91350-200

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

89201-260

Instituto Joinvilense de Hematologia e Oncologia ( Site 1101), Joinville

01509-010

A. C. Camargo Cancer Center ( Site 1106), São Paulo

01009

MEDI-K ( Site 1403), Guatemala City

01010

Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404), Guatemala City

09001

Centro Regional de Sub Especialidades Médicas SA ( Site 1401), Quetzaltenango

09002

Centro Medico Integral De Cancerología (CEMIC) ( Site 1400), Quetzaltenango

470-1192

Fujita Health University Hospital ( Site 4406), Toyoake

830-0011

Kurume University Hospital ( Site 4412), Kurume

373-8550

Gunma Prefectural Cancer Center ( Site 4416), Ōta

003-0804

National Hospital Organization Hokkaido Cancer Center ( Site 4415), Sapporo

236-0051

Kanagawa Cardiovascular and Respiratory Center ( Site 4404), Yokohama

981-1293

Miyagi Cancer Center ( Site 4401), Natori-shi

981-0914

Sendai Kousei Hospital ( Site 4400), Sendai

710-8602

Kurashiki Central Hospital ( Site 4409), Kurashiki

573-1191

Kansai Medical University Hospital ( Site 4408), Hirakata

569-8686

Osaka Medical and Pharmaceutical University Hospital ( Site 4414), Takatsuki

362-0806

Saitama Prefectural Cancer Center ( Site 4402), Kitaadachi-gun

411-8777

Shizuoka Cancer Center ( Site 4405), Sunto-gun,

320-0834

Tochigi Cancer Center ( Site 4417), Utsunomiya

113-8431

Juntendo University Hospital ( Site 4413), Bunkyo-ku

810-8563

National Hospital Organization Kyushu Medical Center ( Site 4411), Fukuoka

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 4410), Fukuoka

541-8567

Osaka International Cancer Institute ( Site 4407), Osaka

113-8603

Nippon Medical School Hospital ( Site 4403), Tokyo

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2800), Warsaw

10-357

Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii ( Site 2802), Olsztyn

75-581

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2801), Koszalin

0001

Steve Biko Academic Hospital-Medical Oncology ( Site 2904), Pretoria

08035

Hospital Universitari Vall d'Hebron-Oncology ( Site 2400), Barcelona

06010

Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504), Ankara

06230

Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506), Ankara

06800

Ankara City Hospital-Medical Oncology ( Site 2501), Ankara

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY