Lung Cancer Clinical Trial

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)

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Has pathologically (histologically or cytologically) confirmed diagnosis of squamous or 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 lymphoma kinase (ALK), or ROS Proto-Oncogene 1, Receptor Tyrosine Kinase (ROS1)-directed therapy is not indicated in nonsquamous NSCLC as well as mixed nonsquamous/squamous NSCLC. Participants with purely squamous NSCLC do not require testing
Has not received prior systemic treatment for their metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development 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 as per protocol unless confirmed to be azoospermic
A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: is not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees of using a contraceptive method 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 biopsy of a tumor lesion not previously irradiated for PD-L1 status determination prior to randomization
Has adequate organ function

Exclusion Criteria:

Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
Has known central nervous system (ie, brain and/or spinal cord) metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate only if they satisfy all of the following: a) Have no evidence of new or enlarging brain metastases confirmed by post-treatment repeat brain imaging performed at least 4 weeks after pretreatment brain imaging, and b) Are neurologically stable without the need for steroids for at least 14 days before first dose of trial treatment as per 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 2 years
Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids 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 Hepatitis B infection or known active Hepatitis C infection
Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study
Has symptomatic ascites or pleural effusion. A participant who is clinically stable after treatment for these conditions is eligible
Before the first dose of study intervention: a) Has received prior systemic cytotoxic chemotherapy for metastatic NSCLC b) Has received antineoplastic biological therapy for metastatic NSCLC c) Has had major surgery (<3 weeks prior to first dose) d) Has received therapy with an anti-programmed cell death 1 (anti-PD-1), ligand (anti-PD-L1), or 2 (anti-PD-L2) agent directed another stimulatory coinhibitory T-cell receptor
Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose 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 other Non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose ≤1.3 g/day, for a 5-day period
For participants with nonsquamous histology: Is unable or unwilling to take folic acid or vitamin B12 supplementation
Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis. Participants must have recovered from all radiation-related toxicities and not require corticosteroids. A 1-week washout is 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 first dose of study intervention
Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention
Has had an allogenic tissue/solid organ transplant

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

512

Study ID:

NCT04956692

Recruitment Status:

Active, not recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 120 Locations for this study

See Locations Near You

St. Bernards Medical Center ( Site 0103)
Jonesboro Arkansas, 72401, United States
St Joseph Heritage Healthcare-Oncology ( Site 0102)
Fullerton California, 92835, United States
Cancer Blood and Specialty Clinic ( Site 0105)
Los Alamitos California, 90720, United States
PIH Health Hematology Medical Oncology ( Site 0106)
Whittier California, 90602, United States
Holy Cross Hospital ( Site 0017)
Fort Lauderdale Florida, 33308, United States
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0104)
Hollywood Florida, 33021, United States
Advent Health ( Site 0013)
Orlando Florida, 32804, United States
Fort Wayne Medical Oncology and Hematology ( Site 0101)
Fort Wayne Indiana, 46804, United States
Baptist Health Lexington ( Site 0099)
Lexington Kentucky, 40503, United States
St Luke's Hospital - Kansas City ( Site 0033)
Kansas City Missouri, 64111, United States
St. Vincent Frontier Cancer Center ( Site 0058)
Billings Montana, 59102, United States
Montefiore Medical Center [Bronx, NY] ( Site 0040)
Bronx New York, 10461, United States
The University of Tennessee Medical Center ( Site 0050)
Knoxville Tennessee, 37920, United States
Tennessee Oncology ( Site 0051)
Nashville Tennessee, 37203, United States
Oncology Consultants, PA ( Site 0052)
Houston Texas, 77030, United States
Millennium Physicians - Oncology ( Site 0097)
Houston Texas, 77090, United States
Oncology & Hematology Assoc. SW Virginia, Inc., DBA Blue Ridge Cancer Care ( Site 0100)
Blacksburg Virginia, 24060, United States
West Virginia University ( Site 0056)
Morgantown West Virginia, 26506, United States
HOSPITAL EVANGÉLICO DE CACHOEIRO DE ITAPEMIRIM ( Site 0307)
Cachoeiro de Itapemirim Espirito Santo, 29308, Brazil
Hospital Sao Vicente de Paulo ( Site 0311)
Passo Fundo Rio Grande Do Sul, 99010, Brazil
Instituto Joinvilense de Hematologia e Oncologia ( Site 0308)
Joinville Santa Catarina, 89201, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto ( Site 0305)
Sao Jose do Rio Preto Sao Paulo, 15090, Brazil
Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0304)
São Paulo Sao Paulo, 04014, Brazil
Nouvel Hôpital Civil (NHC) ( Site 1018)
Strasbourg Bas-Rhin, 67091, France
CHU Limoges CHU Dupuytren ( Site 1011)
Limoges Haute-Vienne, 87042, France
Hôpital Foch ( Site 1019)
Suresnes Hauts-de-Seine, 92150, France
Institut Regional du Cancer de Montpellier - ICM ( Site 1003)
Montpellier Herault, 34298, France
Centre Hospitalier Sud Réunion ( Site 1020)
Saint-Pierre La Reunion, 97448, France
Hopital Guillaume & Rene Laennec ( Site 1007)
Saint-Herblain Loire-Atlantique, 44800, France
Centre Hospitalier de Pau ( Site 1016)
Pau Pyrenees-Atlantiques, 64000, France
CHU de Rouen ( Site 1013)
Rouen Seine-Maritime, 76031, France
Hopital Cochin ( Site 1002)
Paris , 75014, France
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0602)
Guatemala , 01010, Guatemala
Clinica Privada Dr. Rixci Ramirez ( Site 0601)
Guatemala , 01010, Guatemala
INTERVASC ( Site 0605)
Guatemala , 01010, Guatemala
Grupo Angeles SA ( Site 0604)
Guatemala , 01015, Guatemala
Centro Regional de Sub Especialidades Médicas SA ( Site 0600)
Quetzaltenango , 09001, Guatemala
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 1106)
Kecskemét Bacs-Kiskun, 6000, Hungary
Petz Aladar Megyei Oktato Korhaz ( Site 1110)
Gyor Gyor-Moson-Sopron, 9023, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 1103)
Szolnok Jasz-Nagykun-Szolnok, 5000, Hungary
Tudogyogyintezet Torokbalint ( Site 1105)
Torokbalint Pest, 2045, Hungary
Veszprem Megyei Tudogyogyintezet ( Site 1108)
Farkasgyepu Veszprem, 8582, Hungary
Zala Megyei Szent Rafael Korhaz ( Site 1111)
Zalagerszeg Zalaegerszeg, 8900, Hungary
Semmelweis University-Pulmonológiai Klinika ( Site 1114)
Budapest , 1083, Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 1104)
Budapest , 1121, Hungary
Fujita Health University Hospital ( Site 3007)
Toyoake Aichi, 47011, Japan
Ehime University Hospital ( Site 3005)
Toon Ehime, 791-0, Japan
Kurume University Hospital ( Site 3006)
Kurume Fukuoka, 830-0, Japan
National Hospital Organization Hokkaido Cancer Center ( Site 3014)
Sapporo Hokkaido, 003-0, Japan
Kanazawa University Hospital ( Site 3004)
Kanazawa Ishikawa, 920-8, Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 3003)
Yokohama Kanagawa, 236-0, Japan
Miyagi Cancer Center ( Site 3000)
Natori Miyagi, 981-1, Japan
Sendai Kousei Hospital ( Site 3015)
Sendai Miyagi, 980-0, Japan
Kurashiki Central Hospital ( Site 3013)
Kurashiki Okayama, 710-8, Japan
Kansai Medical University Hospital ( Site 3016)
Hirakata Osaka, 573-1, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 3009)
Sakai Osaka, , Japan
Osaka Medical and Pharmaceutical University Hospital ( Site 3017)
Takatsuki Osaka, 569-8, Japan
Chiba University Hospital ( Site 3008)
Chiba , 260-8, Japan
National Hospital Organization Kyushu Medical Center ( Site 3001)
Fukuoka , 810-8, Japan
National Hospital Organization Kyushu Cancer Center ( Site 3002)
Fukuoka , 811-1, Japan
Okayama University Hospital ( Site 3012)
Okayama , 70085, Japan
Osaka International Cancer Institute ( Site 3018)
Osaka , 541-8, Japan
Tokushima University Hospital ( Site 3019)
Tokushima , 770-8, Japan
Juntendo University Hospital ( Site 3011)
Tokyo , 113-8, Japan
Showa University Hospital ( Site 3010)
Tokyo , 142-8, Japan
Chungnam National University Hospital ( Site 2002)
Daejeon Chungnam, 35015, Korea, Republic of
Chonnam National University Hwasun Hospital-Pulmonology ( Site 2000)
Hwasun Jeonranamdo, 58128, Korea, Republic of
Korea University Guro Hospital ( Site 2003)
Seoul , 08308, Korea, Republic of
Hospital Nacional Carlos Alberto Seguin Escobedo ESSALUD ( Site 0704)
Arequipa Ariqipa, 04001, Peru
Clínica Peruano-Americana de Trujillo ( Site 0701)
Trujillo La Libertad, 13007, Peru
Oncosalud ( Site 0706)
Lima Muni Metro De Lima, 15036, Peru
Clinica Internacional Sede San Borja ( Site 0705)
Lima , 15036, Peru
Instituto Nacional de Enfermedades Neoplasicas ( Site 0703)
Lima , 15038, Peru
Hospital Nacional Cayetano Heredia ( Site 0700)
Lima , 15102, Peru
Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 1201)
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1206)
Siedlce Mazowieckie, 08-11, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
Warszawa Mazowieckie, 02-78, Poland
Centrum Pulmonologii i Torakochirurgii w Bystrej ( Site 1205)
Bystra Slaskie, 43-36, Poland
Przychodnia Lekarska KOMED ( Site 1202)
Konin Wielkopolskie, 62-50, Poland
Szpital Wojewodzki im. Mikolaja Kopernika ( Site 1200)
Koszalin Zachodniopomorskie, 75-58, Poland
Cardiomed SRL Cluj-Napoca ( Site 1313)
Cluj-Napoca Cluj, 40001, Romania
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1303)
Cluj-Napoca Cluj, 40001, Romania
SC Radiotherapy Center Cluj SRL ( Site 1307)
Comuna Floresti Cluj, 40728, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1304)
Craiova Dolj, 20034, Romania
Centrul de Oncologie Oncolab-Medical Oncology ( Site 1312)
Craiova Dolj, 20038, Romania
Spitalul Municipal Ploiesti ( Site 1308)
Ploiesti Prahova, 10033, Romania
Policlinica Oncomed SRL ( Site 1302)
Timisoara Timis, 30023, Romania
S.C.Focus Lab Plus S.R.L ( Site 1301)
Bucuresti , 02254, Romania
Spitalul Universitar de Urgenta Bucuresti ( Site 1305)
Bucuresti , 05009, Romania
SPBU Clinic of Advanced medical technologies n.a. N. I. Pirogov ( Site 1406)
Saint-Petersburg Sankt-Peterburg, 19010, Russian Federation
National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1407)
Saint-Petersburg Sankt-Peterburg, 19775, Russian Federation
Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (o) ( Site 1424)
Saint-Petersburg Sankt-Peterburg, 19775, Russian Federation
Republican Clinical Oncology Dispensary-Chemotherapy #1 ( Site 1425)
Kazan Tatarstan, Respublika, 42002, Russian Federation
SPb SBHI City Clinical Oncological Dispensary ( Site 1409)
Sankt-Peterburg , 19825, Russian Federation
Wits Clinical Research ( Site 1510)
Johannesburg Gauteng, 2193, South Africa
Steve Biko Academic Hospital ( Site 1506)
Pretoria Gauteng, 0002, South Africa
Marry Potter Oncology Centre ( Site 1502)
Pretoria Gauteng, 0181, South Africa
Sandton Oncology Medical Group PTY LTD ( Site 1505)
Sandton Gauteng, 2196, South Africa
Chris Hani Baragwanath Academic Hospital-Wits Clinical Research Bara ( Site 1513)
Soweto Gauteng, 2013, South Africa
The Oncology Centre ( Site 1507)
Durban Limpopo, 4001, South Africa
Cape Town Oncology Trials Pty Ltd ( Site 1500)
Kraaifontein Western Cape, 7570, South Africa
Hospital Insular de Gran Canaria-Oncology ( Site 1604)
Las Palmas de Gran Canaria Las Palmas, 35001, Spain
H.U. Vall de Hebron ( Site 1600)
Barcelona , 08035, Spain
Hospital Juan Ramon Jimenez ( Site 1602)
Huelva , 21005, Spain
Hospital Universitario Lucus Augusti ( Site 1603)
Lugo , 27003, Spain
Hospital Universitario La Paz ( Site 1601)
Madrid , 28046, Spain
Changhua Christian Hospital ( Site 2104)
Changhua , 50006, Taiwan
National Taiwan University Hospital Hsin-Chu Branch ( Site 2103)
Hsinchu , 300, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 2107)
Kaohsiung , 807, Taiwan
National Cheng Kung University Hospital ( Site 2105)
Tainan , 704, Taiwan
National Taiwan University Hospital ( Site 2101)
Taipei , 10048, Taiwan
Taipei Veterans General Hospital ( Site 2106)
Taipei , 11217, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 2102)
Taoyuan , 333, Taiwan
Gulhane Egitim ve Arastirma Hastanesi ( Site 1704)
Ankara , 06010, Turkey
Ankara Sehir Hastanesi ( Site 1702)
Ankara , 06800, Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1701)
Istanbul , 34722, Turkey
Ege Universitesi Tip Fakultesi Hastanesi ( Site 1703)
Izmir , 35040, Turkey
Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 1707)
Malatya , 44280, Turkey
Medical Center Mriya Med-Service ( Site 1805)
Kryvyi Rih Dnipropetrovska Oblast, 50000, Ukraine
Communal non profit enterprise Regional Clinical Oncology Center ( Site 1806)
Kharkiv Kharkivska Oblast, 61070, Ukraine
Ukrainian Center of Tomotherapy ( Site 1807)
Kropyvnytskyi Kirovohradska Oblast, 25011, Ukraine
Medical Center Asklepion LLC ( Site 1804)
Khodosivka Kyivska Oblast, 08173, Ukraine
Municipal non-profit enterprise'Odesa Regional Clinical Hosp-Thoracic surgery department. ( Site 181
Odesa Odeska Oblast, 65025, Ukraine
Kremenchuk Regional Oncology Center ( Site 1811)
Kremenchuk Poltavska Oblast, 39617, Ukraine
Kyiv City Clinical Oncology Centre ( Site 1809)
Kyiv , 03115, Ukraine
Medical Center Dobrobut Clinic ( Site 1808)
Kyiv , 03151, Ukraine

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

512

Study ID:

NCT04956692

Recruitment Status:

Active, not recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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