Clinical trial NCT06698042: A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)
Official title: A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS 50% or Greater
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Lung Cancer
Non-Small Cell Lung Cancer
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2024-11-20
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that is metastatic, which means cancer has spread to other parts of the body.

Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to compare what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of squamous or nonsquamous non-small cell lung cancer (NSCLC).
* Measurable disease as assessed by the local site investigator/radiology.

Exclusion Criteria:

* Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.
* Received prior systemic anticancer therapy for their metastatic NSCLC.
* Known additional malignancy that is progressing or has required active treatment within the past 3 years.
* Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Active autoimmune disease that has required systemic treatment in the past 2 years.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Active infection requiring systemic therapy.

Primary outcomes:
measure: Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose
timeFrame: At designated time points (up to approximately 14 months)
measure: Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State
timeFrame: At designated time points (Up to ~18 months)
Secondary outcomes:
measure: Maximum Serum Concentration (Cmax) of Pembrolizumab Measured After the First Dose
timeFrame: At designated time points (Up to ~28 months)
measure: Trough Concentration (Ctrough) of Pembrolizumab Measured After the First Dose
timeFrame: At designated time points (Up to ~28 months)
measure: AUC of Pembrolizumab Measured at Steady State
timeFrame: At designated time points (Up to ~28 months)
measure: Maximum Serum Concentration (Cmax) of Pembrolizumab Measured at Steady State
timeFrame: At designated time points (Up to ~28 months)
measure: Model-based Ctrough of Pembrolizumab Measured After the First Dose
timeFrame: At designated time points (Up to ~28 monhts
measure: Model-based Ctrough of Pembrolizumab Measured at Steady State
timeFrame: At designated time points (Up to ~28 months)
measure: Number of participants with antipembrolizumab antibodies
timeFrame: Baseline and up to approximately 28 months
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 60 months
measure: Progression-free Survival (PFS)
timeFrame: Up to approximately 60 months
measure: Overall survival (OS)
timeFrame: Up to approximately 60 months
measure: Duration of Response (DOR)
timeFrame: Up to approximately 60 months
measure: Number of Participants Who Experience an AE- All Participants
timeFrame: Up to approximately 28 months
measure: Number of Participants Who Discontinue Study Intervention Due to an AE
timeFrame: Up to approximately 25 months
measure: Change in Score from Baseline: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)Global Health Status/Quality of Life (QoL)- Items 29 and 30
timeFrame: Baseline and up to approximately 26 months
measure: Change in Score from Baseline: EORTC QLQ-C30 Physical Functioning (Items 1 to 5)
timeFrame: Baseline and up to approximately 26 months
measure: Change in Score from Baseline: EORTC QLQ-C30 Role functioning (Items 6 and 7)
timeFrame: Baseline and up to approximately 26 months
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Providence Medical Foundation ( Site 0117)
state: California
city: Peoria
country: United States
facility: Illinois Cancer Care ( Site 0101)
state: Illinois
city: Bronx
country: United States
facility: Montefiore Medical Center ( Site 0104)
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center ( Site 0112)
state: Ohio
city: Beijing
country: China
facility: Beijing Peking Union Medical College Hospital ( Site 5000)
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Three Gorges Hospital ( Site 5018)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Province Cancer Hospital ( Site 5007)
state: Fujian
city: XiaMen
country: China
facility: The First Affiliated hospital of Xiamen University ( Site 5008)
state: Fujian
city: Guangzhou
country: China
facility: The first affiliated hospital, Sun Yat-Sen university ( Site 5011)
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital ( Site 5003)
state: Guangdong
city: Huizhou
country: China
facility: Huizhou Central People's Hospital ( Site 5004)
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Center Hospital ( Site 5001)
state: Guangdong
city: Liuzhou
country: China
facility: Liuzhou People's Hospital ( Site 5009)
state: Guangxi
city: Wuhan
country: China
facility: Wuhan Union Hospital Cancer Center-Cancer Center ( Site 5015)
state: Hubei
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University ( Site 5019)
state: Jiangxi
city: Changchun
country: China
facility: Jilin Province Tumor Hospital ( Site 5014)
state: Jilin
city: Jinan
country: China
facility: Jinan Central Hospital ( Site 5012)
state: Shandong
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital ( Site 5010)
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University ( Site 5016)
state: Sichuan
city: Chengdu
country: China
facility: Sichuan Cancer Hospital. ( Site 5006)
state: Sichuan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5021)
state: Zhejiang
city: Linhai
country: China
facility: Taizhou Hospital of Zhejiang Province ( Site 5002)
state: Zhejiang
city: Guatemala.
country: Guatemala
facility: CELAN,S.A ( Site 1104)
city: Guatemala
country: Guatemala
facility: MEDI-K ( Site 1101)
city: Guatemala
country: Guatemala
facility: Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1102)
city: Quetzaltenango
country: Guatemala
facility: Centro Medico Integral De Cancerología (CEMIC) ( Site 1103)
city: Toyoake
country: Japan
facility: Fujita Health University Hospital ( Site 4004)
state: Aichi
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 4007)
state: Ehime
city: Takarazuka
country: Japan
facility: Takarazuka City Hospital ( Site 4006)
state: Hyogo
city: Yokohama
country: Japan
facility: Kanagawa Cardiovascular and Respiratory Center ( Site 4002)
state: Kanagawa
city: Natori
country: Japan
facility: Miyagi Cancer Center ( Site 4000)
state: Miyagi
city: Sakai
country: Japan
facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 4009)
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Prefectural Cancer Center ( Site 4001)
state: Saitama
city: Utsunomiya
country: Japan
facility: Tochigi Cancer Center ( Site 4008)
state: Tochigi
city: Bunkyo
country: Japan
facility: Juntendo University Hospital ( Site 4003)
state: Tokyo
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 4005)
city: Pusan Kwangyokshi
country: Korea, Republic of
facility: Pusan National University Hospital ( Site 3002)
state: Pusan-Kwangyokshi
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital ( Site 3003)
state: Taejon-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 3001)
city: Lima
country: Peru
facility: Clínica Internacional - Sede San Borja ( Site 1002)
city: Lima
country: Peru
facility: IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1004)
city: Lima
country: Peru
facility: Oncosalud ( Site 1000)
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2305)
state: Mazowieckie
city: Warsaw
country: Poland
facility: Narodowy Instytut Onkologii ( Site 2303)
state: Mazowieckie
city: Floresti
country: Romania
facility: SC Radiotherapy Center Cluj SRL ( Site 2203)
state: Cluj
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2201)
state: Dolj
city: Cluj
country: Romania
facility: Institutul Oncologic ( Site 2202)
city: San Sebastian
country: Spain
facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 2454)
state: Gipuzkoa
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d Hebron ( Site 2450)
city: Barcelona
country: Spain
facility: INSTITUTO CATALAN DE ONCOLOGIA- L´HOSPITALET DE LLOBREGAT ( Site 2451)
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez ( Site 2453)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena ( Site 2455)
city: Bornova
country: Turkey
facility: Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2501)
state: Izmir
city: Ankara
country: Turkey
facility: Gulhane Egitim Arastirma Hastanesi ( Site 2504)
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)
city: Ankara
country: Turkey
facility: Gazi University Health Research and Application Center Gazi Hospital-Oncology ( Site 2502)
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi ( Site 2503)
city: İstanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2506)
city: Torquay
country: United Kingdom
facility: Torbay Hospital ( Site 2100)
state: England
city: Truro
country: United Kingdom
facility: The Royal Cornwall Hospital ( Site 2102)
state: England
Study officials:
affiliation: Merck Sharp and Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: