Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)

Last updated: November 14, 2024
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Not Recruiting

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

Cisplatin

Pembrolizumab SC

Paclitaxel

Clinical Study ID

NCT04956692
3475-A86
U1111-1298-0215
jRCT2021210032
MK-3475-A86
2020-002729-27
2023-508308-40
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state.

Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has pathologically (histologically or cytologically) confirmed diagnosis of squamousor nonsquamous non-small cell lung cancer (NSCLC)

  • Has Stage IV (T any, N any, M1a, M1b, or M1c - American Joint Committee on Cancer 8th Edition) squamous or nonsquamous NSCLC

  • Has confirmation that epidermal growth factor receptor (EGFR), Anaplastic lymphomakinase (ALK), or ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1)-directedtherapy is not indicated in nonsquamous NSCLC as well as mixed nonsquamous/squamousNSCLC. Participants with purely squamous NSCLC do not require testing

  • Has not received prior systemic treatment for their metastatic NSCLC. Participantswho received adjuvant or neoadjuvant therapy are eligible if theadjuvant/neoadjuvant therapy was completed at least 12 months prior to thedevelopment of metastatic disease

  • Has an Eastern Cooperative Oncology Group (ECOG) performance score (PS) of 0 or 1

  • Male participants are eligible to participate if they agree to use contraception asper protocol unless confirmed to be azoospermic

  • A female participant is eligible to participate if she is not pregnant orbreastfeeding, and at least one of the following conditions applies: is not a womanof childbearing potential (WOCBP) or is a WOCBP who agrees of using a contraceptivemethod per protocol

  • Has measurable disease per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology

  • Submit an archival tumor tissue sample or newly obtained core or incisional biopsyof a tumor lesion not previously irradiated for PD-L1 status determination prior torandomization

  • Has adequate organ function

Exclusion

Exclusion Criteria:

  • Has a known additional malignancy that is progressing or has required activetreatment within the past 3 years

  • Has known central nervous system (ie, brain and/or spinal cord) metastases and/orcarcinomatous meningitis. Participants with treated brain metastases may participateonly if they satisfy all of the following: a) Have no evidence of new or enlargingbrain metastases confirmed by post-treatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and b) Are neurologically stable withoutthe need for steroids for at least 14 days before first dose of trial treatment asper local site assessment

  • Has severe hypersensitivity to study intervention and/or any of its excipients

  • Has an active autoimmune disease that has required systemic treatment in past 2years

  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease

  • Has an active infection requiring systemic therapy

  • Has a known history of human immunodeficiency virus (HIV) infection and/or HepatitisB infection or known active Hepatitis C infection

  • Has a known psychiatric or substance abuse disorder that would interfere with theparticipant's ability to cooperate with the requirements of the study

  • Has symptomatic ascites or pleural effusion. A participant who is clinically stableafter treatment for these conditions is eligible

  • Before the first dose of study intervention: a) Has received prior systemiccytotoxic chemotherapy for metastatic NSCLC b) Has received antineoplasticbiological therapy for metastatic NSCLC c) Has had major surgery (<3 weeks prior tofirst dose) d) Has received prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmedcell death ligand 2 (anti-PD-L2) agent or with an agent directed to anotherstimulatory or coinhibitory T-cell receptor

  • Received radiation therapy to the lung that is >30 Gray within 6 months of the firstdose of study intervention

  • Is expected to require any other form of antineoplastic therapy while on study

  • For participants with nonsquamous histology: Is unable to interrupt aspirin or otherNon-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3g/day, for a 5-day period

  • For participants with nonsquamous histology: Is unable or unwilling to take folicacid or vitamin B12 supplementation

  • Has received prior radiotherapy within 2 weeks of start of study intervention orhave had a history of radiation pneumonitis. Participants must have recovered fromall radiation-related toxicities and not require corticosteroids. A 1-week washoutis permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease

  • Has received a live or live attenuated vaccine within 30 days prior to the firstdose of study intervention

  • Is currently participating in or has participated in a study of an investigationalagent or has used an investigational device within 4 weeks prior to the first doseof study intervention

  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapyor any other form of immunosuppressive therapy within 7 days prior the first dose ofstudy intervention

  • Has had an allogenic tissue/solid organ transplant

Study Design

Total Participants: 531
Treatment Group(s): 7
Primary Treatment: Cisplatin
Phase: 3
Study Start date:
August 05, 2021
Estimated Completion Date:
October 14, 2026

Connect with a study center

  • HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM ( Site 0307)

    Cachoeiro de Itapemirim, Espirito Santo 29308-065
    Brazil

    Site Not Available

  • Hospital Sao Vicente de Paulo ( Site 0311)

    Passo Fundo, Rio Grande Do Sul 99010-080
    Brazil

    Site Not Available

  • Instituto Joinvilense de Hematologia e Oncologia ( Site 0308)

    Joinville, Santa Catarina 89201260
    Brazil

    Site Not Available

  • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0305)

    Sao Jose do Rio Preto, Sao Paulo 15090-000
    Brazil

    Site Not Available

  • Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0304)

    São Paulo, Sao Paulo 04014-002
    Brazil

    Site Not Available

  • Nouvel Hôpital Civil (NHC) ( Site 1018)

    Strasbourg, Bas-Rhin 67091
    France

    Site Not Available

  • CHU Limoges CHU Dupuytren ( Site 1011)

    Limoges, Haute-Vienne 87042
    France

    Site Not Available

  • Hôpital Foch ( Site 1019)

    Suresnes, Hauts-de-Seine 92150
    France

    Site Not Available

  • Institut Regional du Cancer de Montpellier - ICM ( Site 1003)

    Montpellier, Herault 34298
    France

    Site Not Available

  • Centre Hospitalier Sud Réunion ( Site 1020)

    Saint-Pierre, La Reunion 97448
    France

    Site Not Available

  • Hopital Guillaume & Rene Laennec ( Site 1007)

    Saint-Herblain, Loire-Atlantique 44800
    France

    Site Not Available

  • Centre Hospitalier de Pau ( Site 1016)

    Pau, Pyrenees-Atlantiques 64000
    France

    Site Not Available

  • CHU de Rouen ( Site 1013)

    Rouen, Seine-Maritime 76031
    France

    Site Not Available

  • Hopital Cochin ( Site 1002)

    Paris, 75014
    France

    Site Not Available

  • Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0602)

    Guatemala, 01010
    Guatemala

    Site Not Available

  • Clinica Privada Dr. Rixci Ramirez ( Site 0601)

    Guatemala, 01010
    Guatemala

    Site Not Available

  • Grupo Angeles SA ( Site 0604)

    Guatemala, 01015
    Guatemala

    Site Not Available

  • INTERVASC ( Site 0605)

    Guatemala, 01010
    Guatemala

    Site Not Available

  • Centro Regional de Sub Especialidades Médicas SA ( Site 0600)

    Quetzaltenango, 09001
    Guatemala

    Site Not Available

  • Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1106)

    Kecskemét, Bacs-Kiskun 6000
    Hungary

    Site Not Available

  • Petz Aladar Megyei Oktato Korhaz ( Site 1110)

    Gyor, Gyor-Moson-Sopron 9023
    Hungary

    Site Not Available

  • Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1103)

    Szolnok, Jasz-Nagykun-Szolnok 5000
    Hungary

    Site Not Available

  • Tudogyogyintezet Torokbalint ( Site 1105)

    Torokbalint, Pest 2045
    Hungary

    Site Not Available

  • Veszprem Megyei Tudogyogyintezet ( Site 1108)

    Farkasgyepu, Veszprem 8582
    Hungary

    Site Not Available

  • Zala Megyei Szent Rafael Korhaz ( Site 1111)

    Zalagerszeg, Zalaegerszeg 8900
    Hungary

    Site Not Available

  • Orszagos Koranyi Pulmonologiai Intezet ( Site 1104)

    Budapest, 1121
    Hungary

    Site Not Available

  • Semmelweis University-Pulmonológiai Klinika ( Site 1114)

    Budapest, 1083
    Hungary

    Site Not Available

  • Fujita Health University Hospital ( Site 3007)

    Toyoake, Aichi 4701192
    Japan

    Site Not Available

  • Ehime University Hospital ( Site 3005)

    Toon, Ehime 791-0295
    Japan

    Site Not Available

  • Kurume University Hospital ( Site 3006)

    Kurume, Fukuoka 830-0011
    Japan

    Site Not Available

  • National Hospital Organization Hokkaido Cancer Center ( Site 3014)

    Sapporo, Hokkaido 003-0804
    Japan

    Site Not Available

  • Kanazawa University Hospital ( Site 3004)

    Kanazawa, Ishikawa 920-8641
    Japan

    Site Not Available

  • Kanagawa Cardiovascular and Respiratory Center ( Site 3003)

    Yokohama, Kanagawa 236-0051
    Japan

    Site Not Available

  • Miyagi Cancer Center ( Site 3000)

    Natori, Miyagi 981-1293
    Japan

    Site Not Available

  • Sendai Kousei Hospital ( Site 3015)

    Sendai, Miyagi 980-0873
    Japan

    Site Not Available

  • Kurashiki Central Hospital ( Site 3013)

    Kurashiki, Okayama 710-8602
    Japan

    Site Not Available

  • Kansai Medical University Hospital ( Site 3016)

    Hirakata, Osaka 573-1191
    Japan

    Site Not Available

  • National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3009)

    Sakai, Osaka
    Japan

    Site Not Available

  • Osaka Medical and Pharmaceutical University Hospital ( Site 3017)

    Takatsuki, Osaka 569-8686
    Japan

    Site Not Available

  • Chiba University Hospital ( Site 3008)

    Chiba, 260-8677
    Japan

    Site Not Available

  • National Hospital Organization Kyushu Cancer Center ( Site 3002)

    Fukuoka, 811-1395
    Japan

    Site Not Available

  • National Hospital Organization Kyushu Medical Center ( Site 3001)

    Fukuoka, 810-8563
    Japan

    Site Not Available

  • Okayama University Hospital ( Site 3012)

    Okayama, 7008558
    Japan

    Site Not Available

  • Osaka International Cancer Institute ( Site 3018)

    Osaka, 541-8567
    Japan

    Site Not Available

  • Tokushima University Hospital ( Site 3019)

    Tokushima, 770-8503
    Japan

    Site Not Available

  • Juntendo University Hospital ( Site 3011)

    Tokyo, 113-8431
    Japan

    Site Not Available

  • Showa University Hospital ( Site 3010)

    Tokyo, 142-8666
    Japan

    Site Not Available

  • Chungnam National University Hospital ( Site 2002)

    Daejeon, Chungnam 35015
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital-Pulmonology ( Site 2000)

    Hwasun, Jeonranamdo 58128
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital ( Site 2003)

    Seoul, 08308
    Korea, Republic of

    Site Not Available

  • Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0704)

    Arequipa, Ariqipa 04001
    Peru

    Site Not Available

  • Clínica Peruano-Americana de Trujillo ( Site 0701)

    Trujillo, La Libertad 13007
    Peru

    Site Not Available

  • Oncosalud ( Site 0706)

    Lima, Muni Metro De Lima 15036
    Peru

    Site Not Available

  • Clinica Internacional Sede San Borja ( Site 0705)

    Lima, 15036
    Peru

    Site Not Available

  • Hospital Nacional Cayetano Heredia ( Site 0700)

    Lima, 15102
    Peru

    Site Not Available

  • Instituto Nacional de Enfermedades Neoplasicas ( Site 0703)

    Lima, 15038
    Peru

    Site Not Available

  • Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 1201)

    Bydgoszcz, Kujawsko-pomorskie 85-796
    Poland

    Site Not Available

  • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1206)

    Siedlce, Mazowieckie 08-110
    Poland

    Site Not Available

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (

    Warszawa, Mazowieckie 02-781
    Poland

    Site Not Available

  • Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1205)

    Bystra, Slaskie 43-360
    Poland

    Site Not Available

  • Przychodnia Lekarska KOMED ( Site 1202)

    Konin, Wielkopolskie 62-500
    Poland

    Site Not Available

  • Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1200)

    Koszalin, Zachodniopomorskie 75-581
    Poland

    Site Not Available

  • Cardiomed SRL Cluj-Napoca ( Site 1313)

    Cluj-Napoca, Cluj 400015
    Romania

    Site Not Available

  • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1303)

    Cluj-Napoca, Cluj 400015
    Romania

    Site Not Available

  • SC Radiotherapy Center Cluj SRL ( Site 1307)

    Comuna Floresti, Cluj 407280
    Romania

    Site Not Available

  • Centrul de Oncologie Oncolab-Medical Oncology ( Site 1312)

    Craiova, Dolj 200385
    Romania

    Site Not Available

  • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1304)

    Craiova, Dolj 200347
    Romania

    Site Not Available

  • Spitalul Municipal Ploiesti ( Site 1308)

    Ploiesti, Prahova 100337
    Romania

    Site Not Available

  • Policlinica Oncomed SRL ( Site 1302)

    Timisoara, Timis 300239
    Romania

    Site Not Available

  • S.C.Focus Lab Plus S.R.L ( Site 1301)

    Bucuresti, 022548
    Romania

    Site Not Available

  • Spitalul Universitar de Urgenta Bucuresti ( Site 1305)

    Bucuresti, 050098
    Romania

    Site Not Available

  • National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1407)

    Saint-Petersburg, Sankt-Peterburg 197758
    Russian Federation

    Site Not Available

  • SPBU Clinic of Advanced medical technologies n.a. N. I. Pirogov ( Site 1406)

    Saint-Petersburg, Sankt-Peterburg 190103
    Russian Federation

    Site Not Available

  • Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (o) ( Site 1424)

    Saint-Petersburg, Sankt-Peterburg 197758
    Russian Federation

    Site Not Available

  • Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1425)

    Kazan, Tatarstan, Respublika 420029
    Russian Federation

    Site Not Available

  • SPb SBHI City Clinical Oncological Dispensary ( Site 1409)

    Sankt-Peterburg, 198255
    Russian Federation

    Site Not Available

  • Wits Clinical Research ( Site 1510)

    Johannesburg, Gauteng 2193
    South Africa

    Site Not Available

  • Marry Potter Oncology Centre ( Site 1502)

    Pretoria, Gauteng 0181
    South Africa

    Site Not Available

  • Steve Biko Academic Hospital ( Site 1506)

    Pretoria, Gauteng 0002
    South Africa

    Site Not Available

  • Sandton Oncology Medical Group PTY LTD ( Site 1505)

    Sandton, Gauteng 2196
    South Africa

    Site Not Available

  • Chris Hani Baragwanath Academic Hospital-Wits Clinical Research Bara ( Site 1513)

    Soweto, Gauteng 2013
    South Africa

    Site Not Available

  • The Oncology Centre ( Site 1507)

    Durban, Limpopo 4001
    South Africa

    Site Not Available

  • Cape Town Oncology Trials Pty Ltd ( Site 1500)

    Kraaifontein, Western Cape 7570
    South Africa

    Site Not Available

  • Hospital Insular de Gran Canaria-Oncology ( Site 1604)

    Las Palmas de Gran Canaria, Las Palmas 35001
    Spain

    Site Not Available

  • H.U. Vall de Hebron ( Site 1600)

    Barcelona, 08035
    Spain

    Site Not Available

  • Hospital Juan Ramon Jimenez ( Site 1602)

    Huelva, 21005
    Spain

    Site Not Available

  • Hospital Universitario Lucus Augusti ( Site 1603)

    Lugo, 27003
    Spain

    Site Not Available

  • Hospital Universitario La Paz ( Site 1601)

    Madrid, 28046
    Spain

    Site Not Available

  • Changhua Christian Hospital ( Site 2104)

    Changhua, 50006
    Taiwan

    Site Not Available

  • National Taiwan University Hospital Hsin-Chu Branch ( Site 2103)

    Hsinchu, 300
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2107)

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital ( Site 2105)

    Tainan, 704
    Taiwan

    Site Not Available

  • National Taiwan University Hospital ( Site 2101)

    Taipei, 10048
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital ( Site 2106)

    Taipei, 11217
    Taiwan

    Site Not Available

  • Chang Gung Medical Foundation-Linkou Branch ( Site 2102)

    Taoyuan, 333
    Taiwan

    Site Not Available

  • Ankara Sehir Hastanesi ( Site 1702)

    Ankara, 06800
    Turkey

    Site Not Available

  • Gulhane Egitim ve Arastirma Hastanesi ( Site 1704)

    Ankara, 06010
    Turkey

    Site Not Available

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1701)

    Istanbul, 34722
    Turkey

    Site Not Available

  • Ege Universitesi Tip Fakultesi Hastanesi ( Site 1703)

    Izmir, 35040
    Turkey

    Site Not Available

  • Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 1707)

    Malatya, 44280
    Turkey

    Site Not Available

  • Medical Center Mriya Med-Service ( Site 1805)

    Kryvyi Rih, Dnipropetrovska Oblast 50000
    Ukraine

    Site Not Available

  • Communal non profit enterprise Regional Clinical Oncology Center ( Site 1806)

    Kharkiv, Kharkivska Oblast 61070
    Ukraine

    Site Not Available

  • Ukrainian Center of Tomotherapy ( Site 1807)

    Kropyvnytskyi, Kirovohradska Oblast 25011
    Ukraine

    Site Not Available

  • Medical Center Asklepion LLC ( Site 1804)

    Khodosivka, Kyivska Oblast 08173
    Ukraine

    Site Not Available

  • Municipal non-profit enterprise'Odesa Regional Clinical Hosp-Thoracic surgery department. ( Site 181

    Odesa, Odeska Oblast 65025
    Ukraine

    Site Not Available

  • Kremenchuk Regional Oncology Center ( Site 1811)

    Kremenchuk, Poltavska Oblast 39617
    Ukraine

    Site Not Available

  • Kyiv City Clinical Oncology Centre ( Site 1809)

    Kyiv, 03115
    Ukraine

    Site Not Available

  • Medical Center Dobrobut Clinic ( Site 1808)

    Kyiv, 03151
    Ukraine

    Site Not Available

  • St. Bernards Medical Center ( Site 0103)

    Jonesboro, Arkansas 72401
    United States

    Site Not Available

  • St Joseph Heritage Healthcare-Oncology ( Site 0102)

    Fullerton, California 92835
    United States

    Site Not Available

  • Cancer Blood and Specialty Clinic ( Site 0105)

    Los Alamitos, California 90720
    United States

    Site Not Available

  • PIH Health Hematology Medical Oncology ( Site 0106)

    Whittier, California 90602
    United States

    Site Not Available

  • Holy Cross Hospital ( Site 0017)

    Fort Lauderdale, Florida 33308
    United States

    Site Not Available

  • Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104)

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Advent Health ( Site 0013)

    Orlando, Florida 32804
    United States

    Site Not Available

  • Fort Wayne Medical Oncology and Hematology ( Site 0101)

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Baptist Health Lexington ( Site 0099)

    Lexington, Kentucky 40503
    United States

    Site Not Available

  • St Luke's Hospital - Kansas City ( Site 0033)

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • St. Vincent Frontier Cancer Center ( Site 0058)

    Billings, Montana 59102
    United States

    Site Not Available

  • Montefiore Medical Center [Bronx, NY] ( Site 0040)

    Bronx, New York 10461
    United States

    Site Not Available

  • The University of Tennessee Medical Center ( Site 0050)

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • Tennessee Oncology ( Site 0051)

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Millennium Physicians - Oncology ( Site 0097)

    Houston, Texas 77090
    United States

    Site Not Available

  • Oncology Consultants, PA ( Site 0052)

    Houston, Texas 77030
    United States

    Site Not Available

  • Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100)

    Blacksburg, Virginia 24060
    United States

    Site Not Available

  • West Virginia University ( Site 0056)

    Morgantown, West Virginia 26506
    United States

    Site Not Available

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