Lung CancerPhase 3NCT06698042

A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)

A Phase 3 study testing Pembrolizumab (+) Berahyaluronidase alfa and Pembrolizumab in people with Lung Cancer and Non-Small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 67 sites in 12 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer, Non-Small Cell Lung Cancer
What is being tested?: Pembrolizumab (+) Berahyaluronidase alfa and Pembrolizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 67 participants
Where: 67 sitesin 12 countries
Study dates: 21 Nov 2024to 17 Apr 2027
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

67 sites in 12 countries.

Country

City, postcode or hospital

67 sites in 12 countries

China18 sites

Beijing Peking Union Medical College Hospital ( Site 5000)
Beijing, Beijing Municipality, 100730
Jilin Province Tumor Hospital ( Site 5014)
Changchun, Jilin, 130000
West China Hospital of Sichuan University ( Site 5016)
Chengdu, Sichuan, 610041
Sichuan Cancer Hospital. ( Site 5006)
Chengdu, Sichuan, 610213
Chongqing University Three Gorges Hospital ( Site 5018)
Chongqing, Chongqing Municipality, 404000
Fujian Province Cancer Hospital ( Site 5007)
Fuzhou, Fujian, 350014
The first affiliated hospital, Sun Yat-Sen university ( Site 5011)
Guangzhou, Guangdong, 510080
Southern Medical University Nanfang Hospital ( Site 5003)
Guangzhou, Guangdong, 510515
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine ( Site 5021)
Hangzhou, Zhejiang, 310016
Huizhou Central People's Hospital ( Site 5004)
Huizhou, Guangdong, 516001
Jiangmen Center Hospital ( Site 5001)
Jiangmen, Guangdong, 529030
Jinan Central Hospital ( Site 5012)
Jinan, Shandong, 250013
Taizhou Hospital of Zhejiang Province ( Site 5002)
Linhai, Zhejiang, 317000
Liuzhou People's Hospital ( Site 5009)
Liuzhou, Guangxi, 545006
The First Affiliated Hospital of Nanchang University ( Site 5019)
Nanchang, Jiangxi, 330006
Shanghai Pulmonary Hospital ( Site 5010)
Shanghai, Shanghai Municipality, 200433
Wuhan Union Hospital Cancer Center-Cancer Center ( Site 5015)
Wuhan, Hubei, 430048
The First Affiliated hospital of Xiamen University ( Site 5008)
Xiamen, Fujian, 361003

Other trials in China

Japan13 sites

Juntendo University Hospital ( Site 4003)
Bunkyo, Tokyo, 113-8431
Fukushima Medical University Hospital ( Site 4011)
Fukushima, 960-1295
Saitama Prefectural Cancer Center ( Site 4001)
Kitaadachi-gun, Saitama, 362-0806
Hospital of the University of Occupational and Environmental Health, Japan ( Site 4010)
Kitakyushu, Fukuoka, 807-8556
Kochi Medical School Hospital ( Site 4012)
Nankoku, Kochi, 783-8505
Miyagi Cancer Center ( Site 4000)
Natori-shi, Miyagi, 981-1293
Osaka International Cancer Institute ( Site 4005)
Osaka, 541-8567
National Hospital Organization Kinki-chuo Chest Medical Center ( Site 4009)
Sakai, Osaka, 591-8555
Takarazuka City Hospital ( Site 4006)
Takarazuka, Hyōgo, 665-0827
Ehime University Hospital ( Site 4007)
Tōon, Ehime, 791-0295
Fujita Health University Hospital ( Site 4004)
Toyoake, Aichi-ken, 470-1192
Tochigi Cancer Center ( Site 4008)
Utsunomiya, Tochigi, 320-0834
Kanagawa Cardiovascular and Respiratory Center ( Site 4002)
Yokohama, Kanagawa, 236-0051

Other trials in Japan

Turkey (Türkiye)6 sites

Gulhane Egitim Arastirma Hastanesi ( Site 2504)
Ankara, 06010
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2500)
Ankara, 06230
Gazi University Health Research and Application Center Gazi Hospital-Oncology ( Site 2502)
Ankara, 06560
Ankara Bilkent Sehir Hastanesi ( Site 2503)
Ankara, 06800
Ege Universitesi Hastanesi-Chest Diseases Department ( Site 2501)
Bornova, İzmir, 35100
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi ( Site 2506)
Istanbul, 34722

Other trials in Turkey (Türkiye)

Spain5 sites

Hospital General Universitari Vall d Hebron ( Site 2450)
Barcelona, 08035
INSTITUTO CATALAN DE ONCOLOGIA- L´HOSPITALET DE LLOBREGAT ( Site 2451)
Barcelona, 08908
Onkologikoa - Instituto Oncologico de San Sebastian ( Site 2454)
Donostia / San Sebastian, Gipuzkoa, 20014
Hospital Universitario Juan Ramon Jimenez ( Site 2453)
Huelva, 21005
Hospital Universitario Virgen Macarena ( Site 2455)
Seville, 41009

Other trials in Spain

United States4 sites

University of Cincinnati Medical Center ( Site 0112)
Cincinnati, Ohio, 45219
Providence Medical Foundation ( Site 0117)
Fullerton, California, 92835
Illinois Cancer Care ( Site 0101)
Peoria, Illinois, 61615
Montefiore Medical Center ( Site 0104)
The Bronx, New York, 10461

Other trials in United States

Guatemala4 sites

MEDI-K ( Site 1101)
Guatemala City, 01009
CELAN,S.A ( Site 1104)
Guatemala City, 01010
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1102)
Guatemala City, 01010
Centro Medico Integral De Cancerología (CEMIC) ( Site 1103)
Quetzaltenango, 09002

Other trials in Guatemala

Peru4 sites

Clínica Internacional - Sede San Borja ( Site 1002)
Lima, 15036
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 1004)
Lima, 15036
Oncosalud ( Site 1000)
Lima, 15036
Clínica San Antonio ( Site 1006)
Trujillo, La Libertad, 13008

Other trials in Peru

Romania4 sites

Institutul Oncologic ( Site 2202)
Cluj-Napoca, 400015
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2201)
Craiova, Dolj, 200746
SC Radiotherapy Center Cluj SRL ( Site 2203)
Floreşti, Cluj, 407280
Spitalul Municipal Schuller Ploiești ( Site 2204)
Ploieşti, Prahova, 100337

Other trials in Romania

South Korea3 sites

Chungnam National University Hospital ( Site 3003)
Daejeon, Taejon-Kwangyokshi, 35015
Pusan National University Hospital ( Site 3002)
Pusan Kwangyokshi, Pusan-Kwangyokshi, 49241
Korea University Guro Hospital ( Site 3001)
Seoul, 08308

Other trials in South Korea

Germany2 sites

HELIOS Klinikum Erfurt ( Site 2005)
Erfurt, Thuringia, 99089
Universitätsklinikum Jena ( Site 2002)
Jena, Thuringia, 07747

Other trials in Germany

Poland2 sites

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2305)
Siedlce, Masovian Voivodeship, 08-110
Narodowy Instytut Onkologii ( Site 2303)
Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

United Kingdom2 sites

Torbay Hospital ( Site 2100)
Torquay, England, TQ2 7AA
The Royal Cornwall Hospital ( Site 2102)
Truro, England, TR1 3LJ

Other trials in United Kingdom

About this study

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

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 learn what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.

Conditions: Lung Cancer, Non-Small Cell Lung Cancer
Being tested: Pembrolizumab (+) Berahyaluronidase alfa, Pembrolizumab
Medical subject headings: Lung Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pembrolizumab (+) Berahyaluronidase alfaBiological
Also called MK-3475A
Administered subcutaneously on Day 1 of each cycle
PembrolizumabBiological
Also called MK-3475, KEYTRUDA®, SCH 900475
Administered intravenously on Day 1 of each cycle

Study groups in NCT06698042
Study group	Role	What they receive
Pembrolizumab (+) Berahyaluronidase alfa	Experimental	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. Receives: Biological: Pembrolizumab (+) Berahyaluronidase alfa
Pembrolizumab	Active comparator	"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, Receives: Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Curve (AUC) of Pembrolizumab Measured After the First Dose
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.
Measured: At designated time points (up to approximately 14 months)
Trough Concentration (Ctrough) of Pembrolizumab Measured at Steady State
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
Measured: At designated time points (Up to ~15 months)

Secondary outcomes (2)

Number of Participants Who Experience an AE- All Participants
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.
Measured: Up to approximately 28 months
Number of Participants Who Discontinue Study Intervention Due to an AE
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.
Measured: Up to approximately 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 202417 Apr 2027

First posted20 Nov 2024
Study start21 Nov 2024
Primary completion12 Mar 2026
Study completion17 Apr 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung CancerStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 67 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06698042
Sponsor's protocol ID: 3475A-F84
Other IDs: MK-3475A-F84, 2024-513165-39-00, U1111-1306-1214, jRCT2031240445
Status last verified: Jul 2026
First submitted: 18 Nov 2024
Last updated: 21 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf