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.
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 prior therapy with an anti-programmed cell death 1 (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent or with an agent directed to another stimulatory or 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
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There are 120 Locations for this study
Jonesboro Arkansas, 72401, United States
Fullerton California, 92835, United States
Los Alamitos California, 90720, United States
Whittier California, 90602, United States
Fort Lauderdale Florida, 33308, United States
Hollywood Florida, 33021, United States
Orlando Florida, 32804, United States
Fort Wayne Indiana, 46804, United States
Lexington Kentucky, 40503, United States
Kansas City Missouri, 64111, United States
Billings Montana, 59102, United States
Bronx New York, 10461, United States
Knoxville Tennessee, 37920, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Houston Texas, 77090, United States
Blacksburg Virginia, 24060, United States
Morgantown West Virginia, 26506, United States
Cachoeiro de Itapemirim Espirito Santo, 29308, Brazil
Passo Fundo Rio Grande Do Sul, 99010, Brazil
Joinville Santa Catarina, 89201, Brazil
Sao Jose do Rio Preto Sao Paulo, 15090, Brazil
São Paulo Sao Paulo, 04014, Brazil
Strasbourg Bas-Rhin, 67091, France
Limoges Haute-Vienne, 87042, France
Suresnes Hauts-de-Seine, 92150, France
Montpellier Herault, 34298, France
Saint-Pierre La Reunion, 97448, France
Saint-Herblain Loire-Atlantique, 44800, France
Pau Pyrenees-Atlantiques, 64000, France
Rouen Seine-Maritime, 76031, France
Paris , 75014, France
Guatemala , 01010, Guatemala
Guatemala , 01010, Guatemala
Guatemala , 01010, Guatemala
Guatemala , 01015, Guatemala
Quetzaltenango , 09001, Guatemala
Kecskemét Bacs-Kiskun, 6000, Hungary
Gyor Gyor-Moson-Sopron, 9023, Hungary
Szolnok Jasz-Nagykun-Szolnok, 5000, Hungary
Torokbalint Pest, 2045, Hungary
Farkasgyepu Veszprem, 8582, Hungary
Zalagerszeg Zalaegerszeg, 8900, Hungary
Budapest , 1083, Hungary
Budapest , 1121, Hungary
Toyoake Aichi, 47011, Japan
Toon Ehime, 791-0, Japan
Kurume Fukuoka, 830-0, Japan
Sapporo Hokkaido, 003-0, Japan
Kanazawa Ishikawa, 920-8, Japan
Yokohama Kanagawa, 236-0, Japan
Natori Miyagi, 981-1, Japan
Sendai Miyagi, 980-0, Japan
Kurashiki Okayama, 710-8, Japan
Hirakata Osaka, 573-1, Japan
Sakai Osaka, , Japan
Takatsuki Osaka, 569-8, Japan
Chiba , 260-8, Japan
Fukuoka , 810-8, Japan
Fukuoka , 811-1, Japan
Okayama , 70085, Japan
Osaka , 541-8, Japan
Tokushima , 770-8, Japan
Tokyo , 113-8, Japan
Tokyo , 142-8, Japan
Daejeon Chungnam, 35015, Korea, Republic of
Hwasun Jeonranamdo, 58128, Korea, Republic of
Seoul , 08308, Korea, Republic of
Arequipa Ariqipa, 04001, Peru
Trujillo La Libertad, 13007, Peru
Lima Muni Metro De Lima, 15036, Peru
Lima , 15036, Peru
Lima , 15038, Peru
Lima , 15102, Peru
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland
Siedlce Mazowieckie, 08-11, Poland
Warszawa Mazowieckie, 02-78, Poland
Bystra Slaskie, 43-36, Poland
Konin Wielkopolskie, 62-50, Poland
Koszalin Zachodniopomorskie, 75-58, Poland
Cluj-Napoca Cluj, 40001, Romania
Cluj-Napoca Cluj, 40001, Romania
Comuna Floresti Cluj, 40728, Romania
Craiova Dolj, 20034, Romania
Craiova Dolj, 20038, Romania
Ploiesti Prahova, 10033, Romania
Timisoara Timis, 30023, Romania
Bucuresti , 02254, Romania
Bucuresti , 05009, Romania
Saint-Petersburg Sankt-Peterburg, 19010, Russian Federation
Saint-Petersburg Sankt-Peterburg, 19775, Russian Federation
Saint-Petersburg Sankt-Peterburg, 19775, Russian Federation
Kazan Tatarstan, Respublika, 42002, Russian Federation
Sankt-Peterburg , 19825, Russian Federation
Johannesburg Gauteng, 2193, South Africa
Pretoria Gauteng, 0002, South Africa
Pretoria Gauteng, 0181, South Africa
Sandton Gauteng, 2196, South Africa
Soweto Gauteng, 2013, South Africa
Durban Limpopo, 4001, South Africa
Kraaifontein Western Cape, 7570, South Africa
Las Palmas de Gran Canaria Las Palmas, 35001, Spain
Barcelona , 08035, Spain
Huelva , 21005, Spain
Lugo , 27003, Spain
Madrid , 28046, Spain
Changhua , 50006, Taiwan
Hsinchu , 300, Taiwan
Kaohsiung , 807, Taiwan
Tainan , 704, Taiwan
Taipei , 10048, Taiwan
Taipei , 11217, Taiwan
Taoyuan , 333, Taiwan
Ankara , 06010, Turkey
Ankara , 06800, Turkey
Istanbul , 34722, Turkey
Izmir , 35040, Turkey
Malatya , 44280, Turkey
Kryvyi Rih Dnipropetrovska Oblast, 50000, Ukraine
Kharkiv Kharkivska Oblast, 61070, Ukraine
Kropyvnytskyi Kirovohradska Oblast, 25011, Ukraine
Khodosivka Kyivska Oblast, 08173, Ukraine
Odesa Odeska Oblast, 65025, Ukraine
Kremenchuk Poltavska Oblast, 39617, Ukraine
Kyiv , 03115, Ukraine
Kyiv , 03151, Ukraine
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