A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)

NCT05722015 | Active Not Recruiting Phase 3 Results DMC FDA Drug

• 5 other identifiers: 3475A-D772022-501506-36-00MK-3475A-D77jRCT2031230049U1111-1280-9384
• Study Type: interventional
• Target: 377
• Locations: 16 countries
• Sites: 110

Brief Summary

This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab formulated with berahyaluronidase alfa (MK-3475A) versus (vs) intravenous (IV) pembrolizumab (MK-3475), administered with chemotherapy in first line treatment of adult participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab formulated with berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.

Conditions

Metastatic Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Cycle 1: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab After the First Dose

  AUC0-6 weeks was defined as a measure of pembrolizumab exposure that was calculated as the product of serum drug concentration and time from zero to 6 weeks. Blood samples were collected at pre-specified timepoints to determine AUC0-6 weeks. Per protocol, geometric mean AUC0-6 weeks value of pembrolizumab after the first dose of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and after first dose of pembrolizumab in arm 2 was presented.

  Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days)

• Cycle 3: Trough Serum Concentration (Ctrough) of Pembrolizumab at Steady State

  Ctrough was defined as the lowest serum concentration of pembrolizumab reached at steady state. Blood samples were collected at pre-specified timepoints for the determination of Ctrough. Per protocol, geometric mean Ctrough value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and of pembrolizumab in arm 2 was presented.

  Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days)

Secondary Outcomes (14)

• Cycle 1: Maximum Serum Concentration (Cmax) of Pembrolizumab After the First Dose

  Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days)

• Cycle 1: Trough Serum Concentration (Ctrough) of Pembrolizumab After the First Dose

  Cycle 1: Arm 1: Day 1: Predose and Days 2, 3, 4, 5, 6, 7, 10, 15, 29, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4, 15, 29, and 42 postdose (cycle length = 42 days)

• Cycle 3: Area Under the Curve From Time 0 to 6 Weeks (AUC0-6 Weeks) of Pembrolizumab at Steady State

  Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days)

• Cycle 3: Maximum Serum Concentration (Cmax) of Pembrolizumab at Steady State

  Cycle 3: Arm 1: Day 1: Predose and Days 4, 10, and 42 postdose; Arm 2: Day 1: Predose and at the end of infusion, Days 4 and 42 postdose (cycle length = 42 days)

• Number of Participants Who Test Positive for Anti-Drug Antibodies (ADAs) for Pembrolizumab

  Predose and Postdose on Day 1 of Cycles 1 through 18 (up to approximately 28 months). Each cycle is 6 weeks.

Study Arms (2)

Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy

EXPERIMENTAL

Participants with treatment-naïve metastatic NSCLC receive 790 mg of Pembrolizumab Formulated With Berahyaluronidase Alfa via subcutaneous (SC) injection on Day 1 of each 6-week cycle for 18 cycles (up to approximately 108 weeks) in combination with platinum doublet chemotherapy.

Biological: Pembrolizumab Formulated with Berahyaluronidase Alfa; Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Drug: Filgrastim; Drug: Pegylated filgrastim

Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

ACTIVE COMPARATOR

Participants with treatment-naïve metastatic NSCLC receive 400 mg pembrolizumab intravenous (IV) infusion in combination with platinum doublet chemotherapy.

Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Biological: Pembrolizumab; Drug: Filgrastim; Drug: Pegylated filgrastim

Interventions

Pembrolizumab Formulated with Berahyaluronidase Alfa BIOLOGICAL

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.

Also known as: MK-3475A

Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy

Pemetrexed DRUG

Pemetrexed 500 mg/m² by IV Infusion will be administered for nonsquamous NSCLC as per the schedule specified in arm.

Also known as: Alimta

Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy; Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

Cisplatin DRUG

Cisplatin 75 mg/m² by IV Infusion will be administered for nonsquamous and squamous NSCLC as per the schedule specified in arm.

Also known as: Platinol-AQ

Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy; Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

Carboplatin DRUG

Carboplatin AUC 5 mg/mL/min in nonsquamous and AUC 6 mg/mL/min in squamous NSCLC will be administered as per the schedule specified in arm.

Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy; Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

Paclitaxel DRUG

Paclitaxel 200 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.

Also known as: Taxol

Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy; Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

Nab-paclitaxel DRUG

Nab-paclitaxel 100 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.

Also known as: Albumin-bound paclitaxel

Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy; Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

Pembrolizumab BIOLOGICAL

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.

Also known as: MK-3475, KEYTRUDA

Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

Filgrastim DRUG

Filgrastim will be administered as per the schedule specified for the arm.

Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy; Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

Pegylated filgrastim DRUG

Pegylated filgrastim will be administered as per the schedule specified for the arm.

Arm 1: Pembrolizumab Formulated With Berahyaluronidase Alfa + Platinum Doublet Chemotherapy; Arm 2: Pembrolizumab + Platinum Doublet Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Has histologically or cytologically confirmed diagnosis of squamous or non-squamous Non-small Cell Lung Cancer (NSCLC)
• Must provide archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated
• Has a life expectancy of at least 3 months
• Has a diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
• Has received prior systemic anticancer therapy for metastatic NSCLC
• Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization
• Has received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicity requiring corticosteroids
• Has received radiation therapy to the lung (\>30 Gray) within 6 months of start of study intervention
• Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
• Has an active autoimmune disease that has required systemic treatment in past 2 years
• Has an active infection requiring systemic therapy
• Has a history of human immunodeficiency virus (HIV) infection
• Has a history of Hepatitis B or C

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (110)

St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023)

Phoenix, Arizona, 85004, United States

Location

Clermont Oncology Center ( Site 0018)

Clermont, Florida, 34711, United States

Location

Mid Florida Hematology and Oncology Center ( Site 0010)

Orange City, Florida, 32763, United States

Location

University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022)

Chicago, Illinois, 60612, United States

Location

Orchard Healthcare Research Inc. ( Site 0011)

Skokie, Illinois, 60077, United States

Location

Franciscan Health Lafayette East ( Site 0020)

Lafayette, Indiana, 47905, United States

Location

Mercy Health-Paducah Cancer Center ( Site 0006)

Paducah, Kentucky, 42003, United States

Location

Hattiesburg Clinic Hematology/Oncology ( Site 0008)

Hattiesburg, Mississippi, 39401, United States

Location

Central Care Cancer Center - Bolivar ( Site 0017)

Bolivar, Missouri, 65613, United States

Location

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005)

Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

Location

Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

Location

Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002)

Buenos Aires, Buenos Aires F.D., C1122AAL, Argentina

Location

Instituto Alexander Fleming ( Site 1008)

Buenos Aires, Buenos Aires F.D., C1426ANZ, Argentina

Location

Clinica Adventista Belgrano-Oncology ( Site 1004)

Buenos Aires, Buenos Aires F.D., C1430EGF, Argentina

Location

Sanatorio Parque ( Site 1003)

Rosario, Santa Fe Province, S2000DVC, Argentina

Location

Hospital Italiano de Córdoba ( Site 1000)

Córdoba, X5004BAL, Argentina

Location

CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102)

Fortaleza, Ceará, 60336-232, Brazil

Location

Hospital de Cancer de Pernambuco ( Site 1107)

Recife, Pernambuco, 50040-000, Brazil

Location

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1100)

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Instituto Joinvilense de Hematologia e Oncologia ( Site 1101)

Joinville, Santa Catarina, 89201-260, Brazil

Location

A. C. Camargo Cancer Center ( Site 1106)

São Paulo, 01509-010, Brazil

Location

IC La Serena Research ( Site 1207)

La Serena, Coquimbo Region, 1720430, Chile

Location

Oncocentro Valdivia ( Site 1201)

Valdivia, Los Ríos Region, 5112129, Chile

Location

FALP-UIDO ( Site 1203)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Oncovida ( Site 1209)

Santiago, Region M. de Santiago, 7500994, Chile

Location

Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210)

Santiago, Region M. de Santiago, 8330024, Chile

Location

Instituto Nacional del Cancer-CR Investigación ( Site 1211)

Santiago, Region M. de Santiago, 8380455, Chile

Location

Bradfordhill-Clinical Area ( Site 1202)

Santiago, Region M. de Santiago, 8420383, Chile

Location

Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503)

Hefei, Anhui, 230071, China

Location

Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510)

Beijing, Beijing Municipality, 100142, China

Location

Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501)

Beijing, Beijing Municipality, 100730, China

Location

Beijing Chest Hospital,Capital Medical University ( Site 4511)

Beijing, Beijing Municipality, 101149, China

Location

Chongqing University Three Gorges Hospital ( Site 4516)

Wanzhou, Chongqing Municipality, 404199, China

Location

Fujian Provincial Cancer Hospital ( Site 4517)

Fuzhou, Fujian, 350014, China

Location

Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 4519)

Guangzhou, Guangdong, 510515, China

Location

Jiangmen Center Hospital ( Site 4509)

Jiangmen, Guangdong, 529030, China

Location

ShenZhen People's Hospital ( Site 4504)

Shenzhen, Guangdong, 518020, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 4502)

Wuhan, Hubei, 430048, China

Location

The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515)

Nanchang, Jiangxi, 330006, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520)

Xi'an, Shaanxi, 710061, China

Location

Fudan University Shanghai Cancer Center-Oncology ( Site 4512)

Shanghai, Shanghai Municipality, 200032, China

Location

Shanxi Cancer Hospital ( Site 4521)

Taiyuan, Shanxi, 410013, China

Location

Tianjin Chest Hospital ( Site 4518)

Tianjin, Tianjin Municipality, 300051, China

Location

The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514)

Hangzhou, Zhejiang, 310003, China

Location

Taizhou Hospital of Zhejiang Province ( Site 4508)

Linhai, Zhejiang, 317000, China

Location

Centre Hospitalier de Cornouaille Quimper - Concarneau ( Site 2600)

Quimper, Finistere, 29107, France

Location

Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 2602)

Tours, Indre-et-Loire, 37000, France

Location

Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 2603)

Paris, 75014, France

Location

MEDI-K ( Site 1403)

Guatemala City, 01009, Guatemala

Location

Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404)

Guatemala City, 01010, Guatemala

Location

Centro Regional de Sub Especialidades Médicas SA ( Site 1401)

Quetzaltenango, 09001, Guatemala

Location

Centro Medico Integral De Cancerología (CEMIC) ( Site 1400)

Quetzaltenango, 09002, Guatemala

Location

Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2102)

Kecskemét, Bács-Kiskun county, 6000, Hungary

Location

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2103)

Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary

Location

Reformatus Pulmonologiai Centrum ( Site 2105)

Törökbálint, Pest County, 2045, Hungary

Location

Semmelweis Egyetem-Pulmonológiai Klinika ( Site 2104)

Budapest, 1083, Hungary

Location

Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2100)

Budapest, 1121, Hungary

Location

Fujita Health University Hospital ( Site 4406)

Toyoake, Aichi-ken, 470-1192, Japan

Location

Kurume University Hospital ( Site 4412)

Kurume, Fukuoka, 830-0011, Japan

Location

Gunma Prefectural Cancer Center ( Site 4416)

Ōta, Gunma, 373-8550, Japan

Location

National Hospital Organization Hokkaido Cancer Center ( Site 4415)

Sapporo, Hokkaido, 003-0804, Japan

Location

Kanagawa Cardiovascular and Respiratory Center ( Site 4404)

Yokohama, Kanagawa, 236-0051, Japan

Location

Miyagi Cancer Center ( Site 4401)

Natori-shi, Miyagi, 981-1293, Japan

Location

Sendai Kousei Hospital ( Site 4400)

Sendai, Miyagi, 981-0914, Japan

Location

Kurashiki Central Hospital ( Site 4409)

Kurashiki, Okayama-ken, 710-8602, Japan

Location

Kansai Medical University Hospital ( Site 4408)

Hirakata, Osaka, 573-1191, Japan

Location

Osaka Medical and Pharmaceutical University Hospital ( Site 4414)

Takatsuki, Osaka, 569-8686, Japan

Location

Saitama Prefectural Cancer Center ( Site 4402)

Kitaadachi-gun, Saitama, 362-0806, Japan

Location

Shizuoka Cancer Center ( Site 4405)

Sunto-gun,, Shizuoka, 411-8777, Japan

Location

Tochigi Cancer Center ( Site 4417)

Utsunomiya, Tochigi, 320-0834, Japan

Location

Juntendo University Hospital ( Site 4413)

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

National Hospital Organization Kyushu Medical Center ( Site 4411)

Fukuoka, 810-8563, Japan

Location

National Hospital Organization Kyushu Cancer Center ( Site 4410)

Fukuoka, 811-1395, Japan

Location

Osaka International Cancer Institute ( Site 4407)

Osaka, 541-8567, Japan

Location

Nippon Medical School Hospital ( Site 4403)

Tokyo, 113-8603, Japan

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2800)

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii ( Site 2802)

Olsztyn, Warmian-Masurian Voivodeship, 10-357, Poland

Location

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2801)

Koszalin, West Pomeranian Voivodeship, 75-581, Poland

Location

SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2303)

Florești, Cluj, 407280, Romania

Location

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2301)

Craiova, Dolj, 200542, Romania

Location

Cabinet Medical Oncomed ( Site 2305)

Timișoara, Timiș County, 300239, Romania

Location

Institutul Oncologic-Oncologie Medicala ( Site 2302)

Cluj-Napoca, 400015, Romania

Location

CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903)

Port Elizabeth, Eastern Cape, 6055, South Africa

Location

Medical Oncology Centre of Rosebank ( Site 2907)

Johannesburg, Gauteng, 2196, South Africa

Location

Steve Biko Academic Hospital-Medical Oncology ( Site 2904)

Pretoria, Gauteng, 0001, South Africa

Location

Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900)

Sandton, Gauteng, 2196, South Africa

Location

The Oncology Centre ( Site 2901)

Durban, KwaZulu-Natal, 4091, South Africa

Location

Cape Town Oncology Trials ( Site 2902)

Cape Town, Western Cape, 7570, South Africa

Location

CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2404)

Santiago de Compostela, La Coruna, 15706, Spain

Location

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2401)

Madrid, Madrid, Comunidad de, 28009, Spain

Location

Hospital Universitari Vall d'Hebron-Oncology ( Site 2400)

Barcelona, 08035, Spain

Location

Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2402)

Huelva, 21005, Spain

Location

National Taiwan University Cancer Center (NTUCC) ( Site 4205)

Taipei City, Taipei, 106, Taiwan

Location

Changhua Christian Hospital ( Site 4203)

Changhua, 50006, Taiwan

Location

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207)

Kaohsiung City, 807, Taiwan

Location

E-Da hospital ( Site 4208)

Kaohsiung City, 82445, Taiwan

Location

Chang Gung Memorial Hospital at Kaohsiung ( Site 4200)

Kaohsiung City, 83301, Taiwan

Location

National Cheng Kung University Hospital ( Site 4202)

Tainan, 704, Taiwan

Location

National Taiwan University Hospital-Oncology ( Site 4204)

Taipei, 10002, Taiwan

Location

Chulalongkorn University ( Site 4301)

Bangkok, Bangkok, 10330, Thailand

Location

Division of Medical Oncology, Siriraj H ( Site 4303)

Bangkok, Bangkok, 10700, Thailand

Location

Songklanagarind hospital ( Site 4302)

Songkhla, Changwat Songkhla, 90110, Thailand

Location

Maharaj Nakorn Chiang Mai Hospital ( Site 4300)

Chiang Mai, 50200, Thailand

Location

Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504)

Ankara, 06010, Turkey (Türkiye)

Location

Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506)

Ankara, 06230, Turkey (Türkiye)

Location

Ankara City Hospital-Medical Oncology ( Site 2501)

Ankara, 06800, Turkey (Türkiye)

Location

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)

Istanbul, 34722, Turkey (Türkiye)

Location

I.E.U. Medical Point Hastanesi-Oncology ( Site 2507)

Izmir, 35575, Turkey (Türkiye)

Location

Memorial Kayseri Hastanesi ( Site 2500)

Kayseri, 38010, Turkey (Türkiye)

Location

İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503)

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (1)

• Felip E, Rojas CI, Schenker M, Kowalski DM, Casarini IA, Csoszi T, Sendur MAN, Martins J, Calles Blanco A, Wang CC, Wang M, Ramirez Fallas RAL, Yoshioka H, Nair S, Song X, Deng X, Lala M, Eiras R, Takahashi T. Subcutaneous versus intravenous pembrolizumab, in combination with chemotherapy, for treatment of metastatic non-small-cell lung cancer: the phase III 3475A-D77 trial. Ann Oncol. 2025 Jul;36(7):775-785. doi: 10.1016/j.annonc.2025.03.012. Epub 2025 Mar 27.

  PMID: 40157574 RESULT

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Cisplatin; Carboplatin; Paclitaxel; 130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; pembrolizumab; Filgrastim

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Albumins; Proteins; Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 10, 2023
• Study Start: February 14, 2023
• Primary Completion: July 12, 2024
• Study Completion (Estimated): May 22, 2028
• Last Updated: September 11, 2025
• Results First Posted: July 28, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

FR (3); US (9); CN (17); JP (18); CL (7); RO (4); ES (4); HU (5); PL (3); BR (5); TH (4); ZA (6); TW (7); TU (7); GU (4); AR (7)