A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)
- Conditions
- Lung CancerNon-Small Cell Lung Cancer
- Interventions
- Registration Number
- NCT06698042
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pembrolizumab (+) Berahyaluronidase alfa Pembrolizumab (+) 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. Pembrolizumab 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,
- Primary Outcome Measures
Name Time Method Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose At designated time points (up to approximately 14 months) AUC is defined as area under curve exposure. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State At designated time points (Up to ~18 months) Ctrough is defined as the trough concentration at steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough
- Secondary Outcome Measures
Name Time Method Trough Concentration (Ctrough) of Pembrolizumab Measured After the First Dose At designated time points (Up to ~28 months) Ctrough is defined as the trough concentration. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Ctrough.
Maximum Serum Concentration (Cmax) of Pembrolizumab Measured After the First Dose At designated time points (Up to ~28 months) Cmax is defined as the peak concentration over the dosing interval. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax.
AUC of Pembrolizumab Measured at Steady State At designated time points (Up to ~28 months) AUC is defined as area under curve exposure at steady state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine AUC.
Maximum Serum Concentration (Cmax) of Pembrolizumab Measured at Steady State At designated time points (Up to ~28 months) Cmax is defined as the peak concentration over the dosing interval in steady-state. Blood samples collected pre-dose and at multiple timepoints post-dose will be used to determine Cmax
Model-based Ctrough of Pembrolizumab Measured After the First Dose At designated time points (Up to ~28 monhts Model-based Ctrough is defined as the value of trough concentration at the end of the dosing interval, as predicted by the population PK model.
Model-based Ctrough of Pembrolizumab Measured at Steady State At designated time points (Up to ~28 months) Model-based steady-state Ctrough is defined as the value of trough concentration at the end of the dosing interval at steady-state, as predicted by the population PK model.
Number of participants with antipembrolizumab antibodies Baseline and up to approximately 28 months Blood samples are to be collected at designated time points for the determination of the presence or absence of anti-pembrolizumab antibodies. The percentage of participants who develop anti pembrolizumab antibodies will be reported.
Objective Response Rate (ORR) Up to approximately 60 months ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Progression-free Survival (PFS) Up to approximately 60 months PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1). PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review (BICR) will be presented.
Duration of Response (DOR) Up to approximately 60 months For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented
Number of Participants Who Experience an AE- All Participants Up to approximately 28 months An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
Overall survival (OS) Up to approximately 60 months OS is defined as time from randomization to death due to any cause.
Number of Participants Who Discontinue Study Intervention Due to an AE Up to approximately 25 months An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment.
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 Baseline and up to approximately 26 months The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7- point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score will be presented.
Change in Score from Baseline: EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Baseline and up to approximately 26 months Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Change in Score from Baseline: EORTC QLQ-C30 Role functioning (Items 6 and 7) Baseline and up to approximately 26 months Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented. The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function.
Trial Locations
- Locations (55)
Osaka International Cancer Institute ( Site 4005)
🇯🇵Osaka, Japan
Illinois Cancer Care ( Site 0101)
🇺🇸Peoria, Illinois, United States
Montefiore Medical Center ( Site 0104)
🇺🇸Bronx, New York, United States
Beijing Peking Union Medical College Hospital ( Site 5000)
🇨🇳Beijing, Beijing, China
Chongqing University Three Gorges Hospital ( Site 5018)
🇨🇳Chongqing, Chongqing, China
Fujian Province Cancer Hospital ( Site 5007)
🇨🇳Fuzhou, Fujian, China
The First Affiliated hospital of Xiamen University ( Site 5008)
🇨🇳XiaMen, Fujian, China
The first affiliated hospital, Sun Yat-Sen university ( Site 5011)
🇨🇳Guangzhou, Guangdong, China
Southern Medical University Nanfang Hospital ( Site 5003)
🇨🇳Guangzhou, Guangdong, China
Huizhou Central People's Hospital ( Site 5004)
🇨🇳Huizhou, Guangdong, China
Takarazuka City Hospital ( Site 4006)
🇯🇵Takarazuka, Hyogo, Japan
Jiangmen Center Hospital ( Site 5001)
🇨🇳Jiangmen, Guangdong, China
Liuzhou People's Hospital ( Site 5009)
🇨🇳Liuzhou, Guangxi, China
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 5015)
🇨🇳Wuhan, Hubei, China
The First Affiliated Hospital of Nanchang University ( Site 5019)
🇨🇳Nanchang, Jiangxi, China
Jilin Province Tumor Hospital ( Site 5014)
🇨🇳Changchun, Jilin, China
Jinan Central Hospital ( Site 5012)
🇨🇳Jinan, Shandong, China
Shanghai Pulmonary Hospital ( Site 5010)
🇨🇳Shanghai, Shanghai, China
West China Hospital of Sichuan University ( Site 5016)
🇨🇳Chengdu, Sichuan, China
Sichuan Cancer Hospital. ( Site 5006)
🇨🇳Chengdu, Sichuan, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5021)
🇨🇳Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province ( Site 5002)
🇨🇳Linhai, Zhejiang, China
CELAN,S.A ( Site 1104)
🇬🇹Guatemala., Guatemala
MEDI-K ( Site 1101)
🇬🇹Guatemala, Guatemala
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1102)
🇬🇹Guatemala, Guatemala
Centro Medico Integral De Cancerología (CEMIC) ( Site 1103)
🇬🇹Quetzaltenango, Guatemala
Fujita Health University Hospital ( Site 4004)
🇯🇵Toyoake, Aichi, Japan
Ehime University Hospital ( Site 4007)
🇯🇵Toon, Ehime, Japan
Kanagawa Cardiovascular and Respiratory Center ( Site 4002)
🇯🇵Yokohama, Kanagawa, Japan
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 4009)
🇯🇵Sakai, Osaka, Japan
Clínica Internacional - Sede San Borja ( Site 1002)
🇵🇪Lima, Peru
Miyagi Cancer Center ( Site 4000)
🇯🇵Natori, Miyagi, Japan
Saitama Prefectural Cancer Center ( Site 4001)
🇯🇵Kitaadachi-gun, Saitama, Japan
Tochigi Cancer Center ( Site 4008)
🇯🇵Utsunomiya, Tochigi, Japan
Juntendo University Hospital ( Site 4003)
🇯🇵Bunkyo, Tokyo, Japan
Korea University Guro Hospital ( Site 3001)
🇰🇷Seoul, Korea, Republic of
Pusan National University Hospital ( Site 3002)
🇰🇷Pusan Kwangyokshi, Pusan-Kwangyokshi, Korea, Republic of
Chungnam National University Hospital ( Site 3003)
🇰🇷Daejeon, Taejon-Kwangyokshi, Korea, Republic of
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1004)
🇵🇪Lima, Peru
Oncosalud ( Site 1000)
🇵🇪Lima, Peru
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2305)
🇵🇱Siedlce, Mazowieckie, Poland
Narodowy Instytut Onkologii ( Site 2303)
🇵🇱Warsaw, Mazowieckie, Poland
SC Radiotherapy Center Cluj SRL ( Site 2203)
🇷🇴Floresti, Cluj, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2201)
🇷🇴Craiova, Dolj, Romania
Institutul Oncologic ( Site 2202)
🇷🇴Cluj, Romania
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 2454)
🇪🇸San Sebastian, Gipuzkoa, Spain
Hospital General Universitari Vall d Hebron ( Site 2450)
🇪🇸Barcelona, Spain
INSTITUTO CATALAN DE ONCOLOGIA- L´HOSPITALET DE LLOBREGAT ( Site 2451)
🇪🇸Barcelona, Spain
Hospital Universitario Juan Ramon Jimenez ( Site 2453)
🇪🇸Huelva, Spain
Hospital Universitario Virgen Macarena ( Site 2455)
🇪🇸Sevilla, Spain
Gulhane Egitim Arastirma Hastanesi ( Site 2504)
🇹🇷Ankara, Turkey
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)
🇹🇷Ankara, Turkey
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2506)
🇹🇷İstanbul, Turkey
Torbay Hospital ( Site 2100)
🇬🇧Torquay, England, United Kingdom
The Royal Cornwall Hospital ( Site 2102)
🇬🇧Truro, England, United Kingdom