Metastatic Non-small Cell Lung CancerPhase 3NCT05722015
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)
A Phase 3 study testing Pembrolizumab Formulated with Berahyaluronidase Alfa, Pemetrexed and Cisplatin in people with Metastatic Non-small Cell Lung Cancer, run by Merck Sharp & Dohme LLC at 110 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Non-small Cell Lung Cancer
- What is being tested?
- Pembrolizumab Formulated with Berahyaluronidase Alfa, Pemetrexed and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 377 participants
- Where
- 110 sitesin 16 countries
- Study dates
- 14 Feb 2023to 22 May 2028
- 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
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
- Has not adequately recovered from major surgery or has ongoing surgical complications
- Has a history of allogenic tissue/solid organ transplant
Trial locations and contacts
110 sites in 16 countries.
110 sites in 16 countries
Japan18 sites
Juntendo University Hospital ( Site 4413)
Bunkyo-ku, Tokyo, 113-8431
National Hospital Organization Kyushu Medical Center ( Site 4411)
Fukuoka, 810-8563
National Hospital Organization Kyushu Cancer Center ( Site 4410)
Fukuoka, 811-1395
Kansai Medical University Hospital ( Site 4408)
Hirakata, Osaka, 573-1191
Saitama Prefectural Cancer Center ( Site 4402)
Kitaadachi-gun, Saitama, 362-0806
Kurashiki Central Hospital ( Site 4409)
Kurashiki, Okayama-ken, 710-8602
Kurume University Hospital ( Site 4412)
Kurume, Fukuoka, 830-0011
Miyagi Cancer Center ( Site 4401)
Natori-shi, Miyagi, 981-1293
Osaka International Cancer Institute ( Site 4407)
Osaka, 541-8567
Gunma Prefectural Cancer Center ( Site 4416)
Ōta, Gunma, 373-8550
National Hospital Organization Hokkaido Cancer Center ( Site 4415)
Sapporo, Hokkaido, 003-0804
Sendai Kousei Hospital ( Site 4400)
Sendai, Miyagi, 981-0914
Shizuoka Cancer Center ( Site 4405)
Sunto-gun,, Shizuoka, 411-8777
Osaka Medical and Pharmaceutical University Hospital ( Site 4414)
Takatsuki, Osaka, 569-8686
Nippon Medical School Hospital ( Site 4403)
Tokyo, 113-8603
Fujita Health University Hospital ( Site 4406)
Toyoake, Aichi-ken, 470-1192
Tochigi Cancer Center ( Site 4417)
Utsunomiya, Tochigi, 320-0834
Kanagawa Cardiovascular and Respiratory Center ( Site 4404)
Yokohama, Kanagawa, 236-0051
China17 sites
Beijing Cancer hospital-intrathoratic deparmtment II ( Site 4510)
Beijing, Beijing Municipality, 100142
Beijing Peking Union Medical College Hospital-pneumology department ( Site 4501)
Beijing, Beijing Municipality, 100730
Beijing Chest Hospital,Capital Medical University ( Site 4511)
Beijing, Beijing Municipality, 101149
Fujian Provincial Cancer Hospital ( Site 4517)
Fuzhou, Fujian, 350014
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 4519)
Guangzhou, Guangdong, 510515
The First Affiliated Hospital, Zhejiang University-Respiratory Department ( Site 4514)
Hangzhou, Zhejiang, 310003
Anhui Provincial Hospital-Cancer Chemotherapy Department ( Site 4503)
Hefei, Anhui, 230071
Jiangmen Center Hospital ( Site 4509)
Jiangmen, Guangdong, 529030
Taizhou Hospital of Zhejiang Province ( Site 4508)
Linhai, Zhejiang, 317000
The First Affiliated Hospital of Nanchang University-Respiratory Medicine Department ( Site 4515)
Nanchang, Jiangxi, 330006
Fudan University Shanghai Cancer Center-Oncology ( Site 4512)
Shanghai, Shanghai Municipality, 200032
ShenZhen People's Hospital ( Site 4504)
Shenzhen, Guangdong, 518020
Shanxi Cancer Hospital ( Site 4521)
Taiyuan, Shanxi, 410013
Tianjin Chest Hospital ( Site 4518)
Tianjin, Tianjin Municipality, 300051
Chongqing University Three Gorges Hospital ( Site 4516)
Wanzhou, Chongqing Municipality, 404199
Union Hospital Tongji Medical College Huazhong University of Science and Technology-Medical Oncology ( Site 4502)
Wuhan, Hubei, 430048
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 4520)
Xi'an, Shaanxi, 710061
United States9 sites
Central Care Cancer Center - Bolivar ( Site 0017)
Bolivar, Missouri, 65613
University of Illinois at Chicago-University of Illinois Cancer Center ( Site 0022)
Chicago, Illinois, 60612
Clermont Oncology Center ( Site 0018)
Clermont, Florida, 34711
Hattiesburg Clinic Hematology/Oncology ( Site 0008)
Hattiesburg, Mississippi, 39401
Franciscan Health Lafayette East ( Site 0020)
Lafayette, Indiana, 47905
Mid Florida Hematology and Oncology Center ( Site 0010)
Orange City, Florida, 32763
Mercy Health-Paducah Cancer Center ( Site 0006)
Paducah, Kentucky, 42003
St. Joseph's Hospital and Medical Center-Dignity Health Cancer Institute ( Site 0023)
Phoenix, Arizona, 85004
Orchard Healthcare Research Inc. ( Site 0011)
Skokie, Illinois, 60077
Argentina7 sites
Instituto Argentino de Diagnóstico y Tratamiento (IADT) ( Site 1002)
Buenos Aires, Buenos Aires F.D., C1122AAL
Instituto Alexander Fleming ( Site 1008)
Buenos Aires, Buenos Aires F.D., C1426ANZ
Clinica Adventista Belgrano-Oncology ( Site 1004)
Buenos Aires, Buenos Aires F.D., C1430EGF
Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 1005)
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB
Hospital Italiano de Córdoba ( Site 1000)
Córdoba, X5004BAL
Instituto de Investigaciones Clínicas Mar del Plata ( Site 1001)
Mar del Plata, Buenos Aires, B7600FZO
Sanatorio Parque ( Site 1003)
Rosario, Santa Fe Province, S2000DVC
Chile7 sites
IC La Serena Research ( Site 1207)
La Serena, Coquimbo Region, 1720430
FALP-UIDO ( Site 1203)
Santiago, Region M. de Santiago, 7500921
Oncovida ( Site 1209)
Santiago, Region M. de Santiago, 7500994
Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 1210)
Santiago, Region M. de Santiago, 8330024
Instituto Nacional del Cancer-CR Investigación ( Site 1211)
Santiago, Region M. de Santiago, 8380455
Bradfordhill-Clinical Area ( Site 1202)
Santiago, Region M. de Santiago, 8420383
Oncocentro Valdivia ( Site 1201)
Valdivia, Los Ríos Region, 5112129
Taiwan7 sites
Changhua Christian Hospital ( Site 4203)
Changhua, 50006
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 4207)
Kaohsiung City, 807
E-Da hospital ( Site 4208)
Kaohsiung City, 82445
Chang Gung Memorial Hospital at Kaohsiung ( Site 4200)
Kaohsiung City, 83301
National Cheng Kung University Hospital ( Site 4202)
Tainan, 704
National Taiwan University Hospital-Oncology ( Site 4204)
Taipei, 10002
National Taiwan University Cancer Center (NTUCC) ( Site 4205)
Taipei City, Taipei, 106
Turkey (Türkiye)7 sites
Gulhane Egitim Arastirma Hastanesi-Oncology ( Site 2504)
Ankara, 06010
Hacettepe Universite Hastaneleri-oncology hospital ( Site 2506)
Ankara, 06230
Ankara City Hospital-Medical Oncology ( Site 2501)
Ankara, 06800
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 2502)
Istanbul, 34722
I.E.U. Medical Point Hastanesi-Oncology ( Site 2507)
Izmir, 35575
Memorial Kayseri Hastanesi ( Site 2500)
Kayseri, 38010
İnönü Üniversitesi Turgut Özal Tıp Merkezi-medical oncology depertmant ( Site 2503)
Malatya, 44280
South Africa6 sites
Cape Town Oncology Trials ( Site 2902)
Cape Town, Western Cape, 7570
The Oncology Centre ( Site 2901)
Durban, KwaZulu-Natal, 4091
Medical Oncology Centre of Rosebank ( Site 2907)
Johannesburg, Gauteng, 2196
CANCERCARE LANGENHOVEN DRIVE ONCOLOGY CENTRE ( Site 2903)
Port Elizabeth, Eastern Cape, 6055
Steve Biko Academic Hospital-Medical Oncology ( Site 2904)
Pretoria, Gauteng, 0001
Sandton Oncology Medical Group (Pty) Ltd-Research ( Site 2900)
Sandton, Gauteng, 2196
Brazil5 sites
CRIO - CENTRO REGIONAL INTEGRADO DE ONCOLOGIA-Pesquisa Clínica ( Site 1102)
Fortaleza, Ceará, 60336-232
Instituto Joinvilense de Hematologia e Oncologia ( Site 1101)
Joinville, Santa Catarina, 89201-260
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 1100)
Porto Alegre, Rio Grande do Sul, 91350-200
Hospital de Cancer de Pernambuco ( Site 1107)
Recife, Pernambuco, 50040-000
A. C. Camargo Cancer Center ( Site 1106)
São Paulo, 01509-010
Hungary5 sites
Semmelweis Egyetem-Pulmonológiai Klinika ( Site 2104)
Budapest, 1083
Országos Korányi Pulmonológiai Intézet-VI. Tüdöbelosztály és Bronchológia ( Site 2100)
Budapest, 1121
Bacs-Kiskun Megyei Korhaz-Onkoradiologiai Kozpont ( Site 2102)
Kecskemét, Bács-Kiskun county, 6000
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 2103)
Szolnok, Jász-Nagykun-Szolnok, 5004
Reformatus Pulmonologiai Centrum ( Site 2105)
Törökbálint, Pest County, 2045
Guatemala4 sites
MEDI-K ( Site 1403)
Guatemala City, 01009
Private Practice- Dr. Rixci Augusto Lenin Ramírez ( Site 1404)
Guatemala City, 01010
Centro Regional de Sub Especialidades Médicas SA ( Site 1401)
Quetzaltenango, 09001
Centro Medico Integral De Cancerología (CEMIC) ( Site 1400)
Quetzaltenango, 09002
Romania4 sites
Institutul Oncologic-Oncologie Medicala ( Site 2302)
Cluj-Napoca, 400015
Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2301)
Craiova, Dolj, 200542
SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2303)
Florești, Cluj, 407280
Cabinet Medical Oncomed ( Site 2305)
Timișoara, Timiș County, 300239
Spain4 sites
Hospital Universitari Vall d'Hebron-Oncology ( Site 2400)
Barcelona, 08035
Hospital Universitario Juan Ramon Jimenez-Oncología Medica ( Site 2402)
Huelva, 21005
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 2401)
Madrid, Madrid, Comunidad de, 28009
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 2404)
Santiago de Compostela, La Coruna, 15706
Thailand4 sites
Chulalongkorn University ( Site 4301)
Bangkok, Bangkok, 10330
Division of Medical Oncology, Siriraj H ( Site 4303)
Bangkok, Bangkok, 10700
Maharaj Nakorn Chiang Mai Hospital ( Site 4300)
Chiang Mai, 50200
Songklanagarind hospital ( Site 4302)
Songkhla, Changwat Songkhla, 90110
France3 sites
Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 2603)
Paris, 75014
Centre Hospitalier de Cornouaille Quimper - Concarneau ( Site 2600)
Quimper, Finistere, 29107
Centre Hospitalier Régional Universitaire de Tours - Hôpital Bretonneau ( Site 2602)
Tours, Indre-et-Loire, 37000
Poland3 sites
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2801)
Koszalin, West Pomeranian Voivodeship, 75-581
Warmińsko - Mazurskie Centrum Chorób Płuc w Olsztynie-Oddzial Onkologii z Pododdzialem Chemioterapii ( Site 2802)
Olsztyn, Warmian-Masurian Voivodeship, 10-357
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 2800)
Warsaw, Masovian Voivodeship, 02-781
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, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer
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.
Read the detailed description
Effective as of Amendment 4, participants will no longer be able to start a second course of pembrolizumab. Participants already receiving second course treatment at the time of amendment 4 should continue to receive second course treatment.
- Conditions
- Metastatic Non-small Cell Lung Cancer
- Being tested
- Pembrolizumab Formulated with Berahyaluronidase Alfa, Pemetrexed, Cisplatin, Carboplatin, Paclitaxel
- Medical subject headings
- 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 Formulated with Berahyaluronidase AlfaBiological
Also called MK-3475A
Pembrolizumab (+) Berahyaluronidase alfa SC will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may have been eligible for second course if they met certain protocol-specified criteria prior to study amendment 4.
PemetrexedDrug
Also called Alimta
Pemetrexed 500 mg/m² by IV Infusion will be administered for nonsquamous NSCLC as per the schedule specified in arm.
CisplatinDrug
Also called Platinol-AQ
Cisplatin 75 mg/m² by IV Infusion will be administered for nonsquamous and squamous NSCLC as per the schedule specified in arm.
CarboplatinDrug
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.
PaclitaxelDrug
Also called Taxol
Paclitaxel 200 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.
Nab-paclitaxelDrug
Also called Albumin-bound paclitaxel
Nab-paclitaxel 100 mg/m² by IV Infusion will be administered for squamous NSCLC as per the schedule specified in arm.
PembrolizumabBiological
Also called MK-3475, KEYTRUDA
Pembrolizumab by IV Infusion will be administered for squamous and nonsquamous NSCLC as per the schedule specified in arm; participants may have been eligible for second course if they met certain protocol-specified criteria prior to study amendment 4.
FilgrastimDrug
Filgrastim will be administered as per the schedule specified for the arm.
Pegylated filgrastimDrug
Pegylated filgrastim will be administered as per the schedule specified for the arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Pemetrexed; Drug: Cisplatin; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel; Biological: Pembrolizumab; Drug: Filgrastim; Drug: Pegylated filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Cmax was defined as the maximum serum concentration of pembrolizumab reached after first dose. Blood samples were collected at pre-specified timepoints for the determination of Cmax. Per protocol, geometric mean Cmax 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.
Measured: 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
Ctrough was defined as the lowest serum concentration of pembrolizumab reached after first dose. Blood samples were collected at pre-specified timepoints for the determination of Ctrough. Per protocol, geometric mean Ctrough 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.
Measured: 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
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 at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and pembrolizumab in arm 2 was presented.
Measured: 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
Cmax was defined as the maximum serum concentration of pembrolizumab reached at steady state. Blood samples were collected at pre-specified timepoints to determine Cmax. Per protocol, geometric mean Cmax value of pembrolizumab at steady state of pembrolizumab formulated with berahyaluronidase alfa in arm 1 and pembrolizumab in arm 2 was presented.
Measured: 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
Blood samples were collected at designated time points for the determination of the presence or absence of anti-pembrolizumab antibodies. Per protocol, the number of participants who developed anti pembrolizumab antibodies were reported.
Measured: Predose and Postdose on Day 1 of Cycles 1 through 18 (up to approximately 28 months). Each cycle is 6 weeks.
Objective Response Rate (ORR)
ORR was 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 experienced CR or PR as assessed by Blinded Independent Central Review (BICR) were presented.
Measured: Up to approximately 28 months
Progression-free Survival (PFS)
PFS was 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 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 BICR were presented.
Measured: Up to approximately 28 months
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Measured: Up to approximately 28 months
Duration of Response (DOR)
For participants who demonstrated a confirmed CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until 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 BICR were presented.
Measured: Up to approximately 28 months
Number of Participants Who Experienced at Least One Adverse Event (AE)
An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experienced at least one AE were reported .
Measured: Up to approximately 28 months
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported for Arms 1 and 2.
Measured: Up to approximately 28 months
Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core30 (QLQ-C30) Combined Global Health Status/Quality of Life (Items 29 & 30) Scale Combined Score
EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("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). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in GHS and QoL combined score was presented.
Measured: Baseline and Week 24
Change From Baseline in Physical Functioning (EORTC-QLQ-C30 Items 1-5) Score
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. Per protocol, the change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score was presented.
Measured: Baseline and Week 24
Change From Baseline in the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C30 (QLQ-C30) Role Functioning Score-Items 6 and 7
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and "Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. Higher scores indicate a better level of role functioning. Change from baseline in the EORTC QLQ-C30 role functioning (Items 6-7) combined score was presented.
Measured: Baseline and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start14 Feb 2023
- Primary completion12 Jul 2024
- Study completion22 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Non-small Cell 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
- 377 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722015
- Sponsor's protocol ID
- 3475A-D77
- Other IDs
- 2022-501506-36-00, MK-3475A-D77, jRCT2031230049, U1111-1280-9384
- Status last verified
- Jul 2026
- First submitted
- 27 Jan 2023
- Last updated
- 26 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
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.
PubMed 40157574