Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

NCT06422143 | Recruiting Phase 3 DMC FDA Drug

• 5 other identifiers: 2870-0232023-510128-66-00U1111-1301-2790jRCT2021240015MK-2870-023
• Study Type: interventional
• Target: 851
• Locations: 26 countries
• Sites: 212

Brief Summary

This is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).

Conditions

NSCLC; Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  OS is the time from randomization to death due to any cause.

  Up to ~50 months

Secondary Outcomes (11)

• Progression-Free Survival (PFS)

  Up to ~79 months

• Number of Participants With ≥1 Adverse Event (AE)

  Up to ~79 months

• Number of Participants Discontinuing from Study Therapy Due to AE(s)

  Up to ~79 months

• Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Global health status/Quality of Life (QoL) Score (EORTC QLQ-C30 Items 29 and 30)

  Baseline and up to ~79 months

• Change in Score from Baseline to a Predefined Timepoint in Participant-Reported Dyspnea (EORTC QLQ-C30 Item 8)

  Baseline and up to ~79 months

Study Arms (2)

Maintenance Arm A: Pembrolizumab + sac-TMT

EXPERIMENTAL

During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin area under the curve (AUC) 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. Note: per investigator discretion, carboplatin AUC 5 mg/mL/min q3w or paclitaxel 175mg/m2 q3w may be administered. During the Maintenance phase, participants receive sac-TMT 4 mg/kg infusion every 2 weeks (q2w) until discontinuation criteria is met for sac-TMT; and pembrolizumab 400 mg every 6 weeks (q6w) for 96 weeks.

Biological: Pembrolizumab; Biological: sac-TMT; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel

Maintenance Arm B: Pembrolizumab Monotherapy

ACTIVE COMPARATOR

During the Induction phase, participants receive pembrolizumab 200 mg q3w for 4 cycles, carboplatin AUC 6 (mg/mL/min) q3w for 4 cycles, and paclitaxel 200 mg/m2 q3w for 4 cycles or nab-paclitaxel 100 mg/m2 weekly for 4 cycles. During the Maintenance phase, participants receive pembrolizumab 400 mg q6w for 96 weeks.

Biological: Pembrolizumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Nab-paclitaxel

Interventions

Paclitaxel DRUG

Participants receive 200 mg/m\^2 or 175 mg/m\^2 IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.

Maintenance Arm A: Pembrolizumab + sac-TMT; Maintenance Arm B: Pembrolizumab Monotherapy

Nab-paclitaxel DRUG

Participants receive 100 mg/m\^2 IV infusion on Days 1, 8 and 15 of each 21-day cycle for 4 cycles as background therapy during the study.

Maintenance Arm A: Pembrolizumab + sac-TMT; Maintenance Arm B: Pembrolizumab Monotherapy

Pembrolizumab BIOLOGICAL

Intravenous (IV) infusion

Also known as: KEYTRUDA®, MK-3475, SCH 900475

Maintenance Arm A: Pembrolizumab + sac-TMT; Maintenance Arm B: Pembrolizumab Monotherapy

sac-TMT BIOLOGICAL

IV infusion

Also known as: MK-2870, Sacituzumab tirumotecan

Maintenance Arm A: Pembrolizumab + sac-TMT

Carboplatin DRUG

Participants receive AUC 6 or AUC 5 mg/mL/min IV infusion on Day 1 of each 21-day cycle for 4 cycles as background therapy during the study.

Maintenance Arm A: Pembrolizumab + sac-TMT; Maintenance Arm B: Pembrolizumab Monotherapy

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) \[Stage IV: M1a, M1b, M1c, American Joint Committee on Cancer Staging Manual, version 8\]
• Measurable disease per Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 as assessed by the local site investigator/radiology
• Has life expectancy ≥3 months
• Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 assessed within 7 days prior to allocation
• Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
• Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)
• Participants who are hepatitis B surface antigen (HBsAg)-positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load before allocation
• Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
• Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade ≤1 or baseline (participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible)
• Has adequate organ function
• For Maintenance only (prior to randomization): is without disease progression of their NSCLC, as determined by BICR using RECIST 1.1 after completion of study-specified Induction with an evaluable scan at Week 12 or most recent scan before randomization
• For Maintenance only (prior to randomization): has ECOG PS of 0 or 1 as assessed at the Prerandomization Visit
• For Maintenance only (prior to randomization): all AEs (with the exception of alopecia, Grade ≤2 fatigue, Grade ≤2 peripheral neuropathy, and Grade ≤2 endocrine-related AEs requiring treatment or hormone replacement) have recovered
• For Maintenance only (prior to randomization): has not experienced a pneumonitis/interstitial lung disease (ILD) event during the study-specified induction

You may not qualify if:

• Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements
• History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
• Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea)
• Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and other serious cardiovascular and cerebrovascular diseases within 6 months before study intervention
• HIV-infected participants who have been newly diagnosed or with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
• Received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLC. Note: Prior treatment with chemotherapy and/or radiation as a part of neoadjuvant or adjuvant therapy or chemoradiation therapy for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
• Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti programmed cell death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T lymphocyte-associated protein 4, OX-40, CD137). Note: Prior treatment with an anti-PD-1 or anti-PD-L1 agent for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC
• Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antidrug conjugate (ADC)
• Received radiation therapy to the lung that is \>30 Gray within 6 months of start of study intervention
• Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids
• Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
• Participants who have not adequately recovered from major surgery or have ongoing surgical complications
• Received prior treatment with a topoisomerase I inhibitor-containing ADC
• Is currently receiving a strong inducer/inhibitor of CYP3A4 that cannot be discontinued for the duration of the study (the required washout period before starting sac-TMT is 2 weeks)
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (212)

CARTI Cancer Center ( Site 0006)

Little Rock, Arkansas, 72205, United States

RECRUITING

Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0122)

Burbank, California, 91505, United States

RECRUITING

Sharp Memorial Hospital ( Site 9544)

San Diego, California, 92123, United States

RECRUITING

Intermountain Health Cancer Center Lutheran Hospital ( Site 0119)

Golden, Colorado, 80401, United States

RECRUITING

Intermountain Health St. Mary's Regional Hospital ( Site 0116)

Grand Junction, Colorado, 81501, United States

RECRUITING

Washington Hospital Center ( Site 0037)

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Mid Florida Hematology and Oncology Center ( Site 0109)

Orange City, Florida, 32763, United States

COMPLETED

Centricity Research Columbus Cancer Center ( Site 0111)

Columbus, Georgia, 31904, United States

COMPLETED

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0001)

Marietta, Georgia, 30060, United States

COMPLETED

Southeastern Regional Medical Center ( Site 0004)

Newnan, Georgia, 30265, United States

COMPLETED

University of Chicago Medical Center ( Site 0145)

Chicago, Illinois, 60637, United States

RECRUITING

Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0146)

Minneapolis, Minnesota, 55407, United States

RECRUITING

Capital Health Medical Center - Hopewell ( Site 0034)

Pennington, New Jersey, 08534, United States

RECRUITING

New Mexico Oncology Hematology Consultants Ltd. ( Site 0123)

Albuquerque, New Mexico, 87109, United States

COMPLETED

University of New Mexico Comprehensive Cancer Center ( Site 0135)

Albuquerque, New Mexico, 87131, United States

RECRUITING

St Luke's University Health Network ( Site 0017)

Bethlehem, Pennsylvania, 18015, United States

RECRUITING

Thomas Jefferson University - Clinical Research Institute ( Site 0147)

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Memorial Hermann Cancer Center ( Site 0015)

Houston, Texas, 77030, United States

RECRUITING

Oncology Consultants P.A. ( Site 0124)

Houston, Texas, 77030, United States

RECRUITING

Mays Cancer Center ( Site 0132)

San Antonio, Texas, 78229, United States

RECRUITING

Instituto Alexander Fleming ( Site 0203)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

RECRUITING

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0200)

Mar del Plata, Buenos Aires, B7600FZO, Argentina

RECRUITING

Instituto Médico Río Cuarto ( Site 0204)

Río Cuarto, Córdoba Province, X5800AEV, Argentina

RECRUITING

Fundacion Intecnus ( Site 0205)

Bariloche, Río Negro Province, R8402APU, Argentina

RECRUITING

Sanatorio Parque ( Site 0201)

Rosario, Santa Fe Province, S2000DSV, Argentina

RECRUITING

Hospital Aleman-Oncology ( Site 0202)

Buenos Aires, C1118AAT, Argentina

RECRUITING

Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 0720)

Linz, Upper Austria, 4020, Austria

RECRUITING

Klinik Hietzing ( Site 0740)

Vienna, 1130, Austria

RECRUITING

Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 0730)

Vienna, 1140, Austria

RECRUITING

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 0710)

Vienna, 1210, Austria

RECRUITING

Hospital do Cancer de Pernambuco ( Site 0312)

Recife, Pernambuco, 50040-000, Brazil

RECRUITING

Vencer Centro de Pesquisa Clínica ( Site 0309)

Teresina, Piauí, 64049-200, Brazil

RECRUITING

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0311)

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

RECRUITING

Hospital Nossa Senhora da Conceição ( Site 0300)

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

RECRUITING

Instituto de Oncologia Saint Gallen ( Site 0304)

Santa Cruz do Sul, Rio Grande do Sul, 96830-180, Brazil

RECRUITING

Hospital de Base de São José do Rio Preto ( Site 0310)

São José do Rio Preto, São Paulo, 15090-000, Brazil

RECRUITING

Hospital Paulistano ( Site 0307)

São Paulo, 01321-001, Brazil

RECRUITING

Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 0100)

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

Waterloo Regional Health Network (WRHN) ( Site 0153)

Kitchener, Ontario, N2G 1G3, Canada

RECRUITING

St. Marys Hospital Center ( Site 0105)

Montreal, Quebec, H3T 1M5, Canada

RECRUITING

McGill University Health Centre ( Site 0103)

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Centre integre universitaire de sante et de services sociaux de la Mauricie-et-du-centre-du-quebec ( Site 0106)

Trois-Rivières, Quebec, G8Z 3R9, Canada

RECRUITING

Centro de Investigación del Maule ( Site 0419)

Talca, Maule Region, 3481349, Chile

COMPLETED

FALP ( Site 0409)

Santiago, Region M. de Santiago, 7500921, Chile

RECRUITING

Pontificia Universidad Catolica de Chile-Hemato-Oncology ( Site 0402)

Santiago, Region M. de Santiago, 8330024, Chile

RECRUITING

Bradfordhill-Clinical Area ( Site 0407)

Santiago, Region M. de Santiago, 8420383, Chile

RECRUITING

ONCOCENTRO APYS-ACEREY ( Site 0400)

Viña del Mar, Valparaiso, 2520598, Chile

RECRUITING

Bradford Hill Norte ( Site 0420)

Antofagasta, 1240000, Chile

RECRUITING

Beijing Cancer Hospital ( Site 2411)

Beijing, Beijing Municipality, 100142, China

RECRUITING

Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2410)

Beijing, Beijing Municipality, 100142, China

RECRUITING

Peking Union Medical College Hospital ( Site 2412)

Beijing, Beijing Municipality, 100730, China

ACTIVE NOT RECRUITING

Army Medical Center of People's Liberation Army-respiratory ( Site 2426)

Chongqing, Chongqing Municipality, 400042, China

ACTIVE NOT RECRUITING

Fujian Provincial Cancer Hospital ( Site 2419)

Fuzhou, Fujian, 350014, China

ACTIVE NOT RECRUITING

The First Affiliated hospital of Xiamen University-oncology ( Site 2420)

Xiamen, Fujian, 361003, China

ACTIVE NOT RECRUITING

The First Affiliated Hospital of Guangzhou Medical University ( Site 2417)

Guangzhou, Guangdong, 510160, China

RECRUITING

Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 2416)

Guangzhou, Guangdong, 510515, China

RECRUITING

Harbin Medical University Cancer Hospital-oncology of department ( Site 2415)

Harbin, Heilongjiang, 150000, China

ACTIVE NOT RECRUITING

Henan Cancer Hospital-Pneumology department ( Site 2423)

Zhengzhou, Henan, 450008, China

RECRUITING

Tongji Hospital Tongji Medical,Science & Technology ( Site 2424)

Wuhan, Hubei, 430000, China

ACTIVE NOT RECRUITING

The Second Xiangya Hospital of Central South University-Oncology ( Site 2418)

Changsha, Hunan, 410011, China

RECRUITING

First Huai'an Hospital Affiliated to Nanjing Medical University ( Site 2402)

Huai'an, Jiangsu, 223300, China

ACTIVE NOT RECRUITING

Northern Jiangsu People's Hospital-General Surgery Department ( Site 2403)

Yangzhou, Jiangsu, 225001, China

ACTIVE NOT RECRUITING

The Second Affiliated Hospital of Nanchang University-Oncology Department ( Site 2405)

Nanchang, Jiangxi, 330006, China

RECRUITING

The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 2404)

Nanchang, Jiangxi, 330209, China

ACTIVE NOT RECRUITING

Jilin Province Tumor Hospital-GCP office ( Site 2413)

Changchun, Jilin, 130000, China

RECRUITING

The First Hospital of Jilin University-Oncology ( Site 2414)

Changchun, Jilin, 130021, China

RECRUITING

Shanghai East Hospital ( Site 2428)

Shanghai, Shanghai Municipality, 200120, China

ACTIVE NOT RECRUITING

Shanghai Pulmonary Hospital ( Site 2427)

Shanghai, Shanghai Municipality, 200433, China

ACTIVE NOT RECRUITING

West China Hospital, Sichuan University ( Site 2422)

Chengdu, Sichuan, 610041, China

RECRUITING

Sichuan Cancer hospital. ( Site 2421)

Chengdu, Sichuan, 610042, China

ACTIVE NOT RECRUITING

The Affiliated Cancer Hospital of Xinjiang Medical University ( Site 2425)

Ürümqi, Xinjiang, 830000, China

RECRUITING

The first Affiliated Hospital, Zhejiang University School of Medicine-Respiratory Department ( Site 2406)

Hangzhou, Zhejiang, 310000, China

ACTIVE NOT RECRUITING

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine-Medical Oncology ( Site 2407)

Hangzhou, Zhejiang, 310016, China

ACTIVE NOT RECRUITING

Zhejiang Cancer Hospital-Breast Oncology ( Site 2408)

Hangzhou, Zhejiang, 310022, China

RECRUITING

Taizhou Hospital of Zhejiang Province ( Site 2430)

Taizhou, Zhejiang, 317000, China

RECRUITING

The First Affiliated Hospital of Wenzhou Medical University-Respiratory department ( Site 2409)

Wenzhou, Zhejiang, 325015, China

RECRUITING

Centro Cancerológico del Caribe (CECAC) ( Site 0509)

Barranquilla, Atlántico, 080002, Colombia

RECRUITING

FUNDACION CTIC CENTRO DE TRATAMIENTO E INVESTIGACION SOBRE CANCER LUIS CARLOS SARMIENTO ANGULO ( Site 0500)

Bogotá, Bogota D.C., 110131, Colombia

RECRUITING

Sociedad De Oncología y Hematología Del Cesar SAS-Oncology ( Site 0501)

Valledupar, Cesar Department, 200001, Colombia

RECRUITING

Oncologos del Occidente ( Site 0504)

Pereira, Risaralda Department, 660001, Colombia

RECRUITING

Fundación Valle del Lili-Oncology CIC ( Site 0505)

Cali, Valle del Cauca Department, 760032, Colombia

RECRUITING

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0800)

Brno, Brno-mesto, 656 53, Czechia

RECRUITING

Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni oddeleni ( Site 0803)

Ostrava-Vitkovice, Ostrava Mesto, 703 00, Czechia

RECRUITING

Multiscan-Onkologicke a radiologicke centrum Multiscan Pardubice ( Site 0804)

Pardubice, Pardubice Region, 532 03, Czechia

RECRUITING

Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 0802)

Olomouc, 779 00, Czechia

RECRUITING

Clinique Clairval ( Site 0904)

Marseille, Bouches-du-Rhone, 13009, France

RECRUITING

Hôpital Robert Schuman ( Site 0907)

Vantoux, Lorraine, 57070, France

RECRUITING

Institut de Cancérologie de l'Ouest ( Site 0908)

Angers, Maine-et-Loire, 49055, France

RECRUITING

Sainte Catherine Institut du Cancer Avignon Provence ( Site 0902)

Avignon, Vaucluse, 84000, France

RECRUITING

CHD Vendee ( Site 0901)

La Roche-sur-Yon, Vendee, 85000, France

RECRUITING

Hôpital Saint-Louis ( Site 0906)

Paris, 75475, France

COMPLETED

GEFOS Gesellschaft f. onkologische Studien ( Site 1005)

Dortmund, North Rhine-Westphalia, 44309, Germany

RECRUITING

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 1001)

Essen, North Rhine-Westphalia, 45136, Germany

RECRUITING

Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1000)

Lübeck, Schleswig-Holstein, 23538, Germany

RECRUITING

SRH Wald-Klinikum Gera-Zentrum für klinische Studien ( Site 1006)

Gera, Thuringia, 07548, Germany

RECRUITING

Charité Campus Virchow-Klinikum-Department of Infectious Diseases and Pulmonary Medicine ( Site 1003)

Berlin, 13353, Germany

RECRUITING

Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 1100)

Kecskemét, Bács-Kiskun county, 6000, Hungary

RECRUITING

Petz Aladar Egyetemi Oktato Korhaz ( Site 1101)

Győr, Győr-Moson-Sopron, 9024, Hungary

RECRUITING

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 1103)

Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary

RECRUITING

Reformatus Pulmonologiai Centrum ( Site 1102)

Törökbálint, Pest County, 2045, Hungary

RECRUITING

Zala Megyei Szent Rafael Kórház ( Site 1110)

Zalaegerszeg, Zala County, 8900, Hungary

RECRUITING

Országos Korányi Pulmonológiai Intézet ( Site 1104)

Budapest, 1121, Hungary

RECRUITING

St. James's Hospital ( Site 1200)

Dublin, D08 A978, Ireland

RECRUITING

Rambam Health Care Campus-Oncology Division ( Site 1302)

Haifa, 3109601, Israel

COMPLETED

Shaare Zedek Medical Center ( Site 1300)

Jerusalem, 9103102, Israel

RECRUITING

Rabin Medical Center ( Site 1303)

Petah Tikva, 4941492, Israel

RECRUITING

Sheba Medical Center ( Site 1301)

Ramat Gan, 5265601, Israel

RECRUITING

Istituto Nazionale Tumori IRCCS Fondazione Pascale-Oncologia clinica sperimentale Toraco-Polmonare ( Site 1401)

Naples, Campania, 80131, Italy

RECRUITING

Azienda Ospedaliera S. Giovanni Addolorata-Oncologia Medica ( Site 1409)

Rome, Lazio, 00184, Italy

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1404)

Milan, Lombardy, 20133, Italy

RECRUITING

Fondazione IRCCS San Gerardo dei Tintori-Oncologia ( Site 1412)

Monza, Lombardy, 20900, Italy

RECRUITING

Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1408)

Rozzano, Milano, 20089, Italy

RECRUITING

Istituto Nazionale Tumori Regina Elena-Oncologia Medica 2 ( Site 1402)

Rome, Roma, 00144, Italy

RECRUITING

Azienda Ospedaliera Spedali Civili di Brescia-Oncology ( Site 1414)

Brescia, 25123, Italy

RECRUITING

Ospedale San Martino ( Site 1407)

Genova, 16132, Italy

RECRUITING

Azienda Ospedaliera Maggiore della Carita ( Site 1416)

Novara, 28100, Italy

RECRUITING

Fondazione IRCCS Policlinico San Matteo-Oncology ( Site 1410)

Pavia, 27100, Italy

RECRUITING

Ospedale di Circolo e Fondazione Macchi Varese-Oncology ( Site 1413)

Varese, 21100, Italy

RECRUITING

Centro Ricerche Cliniche di Verona s.r.l. c/o Policlinico G.B.Rossi ( Site 1415)

Verona, 37134, Italy

RECRUITING

Aichi Cancer Center ( Site 2502)

Nagoya, Aichi-ken, 464-8681, Japan

RECRUITING

Nagoya University Hospital ( Site 2519)

Nagoya, Aichi-ken, 466-8560, Japan

RECRUITING

Fujita Health University Hospital ( Site 2515)

Toyoake, Aichi-ken, 470-1192, Japan

RECRUITING

Hirosaki University Hospital ( Site 2514)

Hirosaki, Aomori, 036-8563, Japan

RECRUITING

National Cancer Center Hospital East ( Site 2501)

Kashiwa, Chiba, 277-8577, Japan

RECRUITING

Ehime University Hospital ( Site 2511)

Tōon, Ehime, 791-0295, Japan

RECRUITING

Gunma Prefectural Cancer Center ( Site 2510)

Ōta, Gunma, 373-8550, Japan

RECRUITING

Kobe Minimally Invasive Cancer Center ( Site 2528)

Kobe, Hyōgo, 650-0046, Japan

RECRUITING

Takarazuka City Hospital ( Site 2508)

Takarazuka, Hyōgo, 665-0827, Japan

RECRUITING

Kanazawa University Hospital ( Site 2513)

Kanazawa, Ishikawa-ken, 920-8641, Japan

RECRUITING

St. Marianna University Hospital ( Site 2521)

Kawasaki, Kanagawa, 216-8511, Japan

RECRUITING

Kanagawa Cardiovascular and Respiratory Center ( Site 2518)

Yokohama, Kanagawa, 236-0051, Japan

RECRUITING

Kanagawa Cancer Center ( Site 2504)

Yokohama, Kanagawa, 241-8515, Japan

RECRUITING

Kochi Medical School Hospital ( Site 2526)

Nankoku, Kochi, 783-8505, Japan

RECRUITING

Saiseikai Matsusaka Municipal Hospital ( Site 2522)

Matsusaka, Mie-ken, 515-8544, Japan

RECRUITING

Tohoku University Hospital ( Site 2525)

Sendai, Miyagi, 980-8574, Japan

RECRUITING

Sendai Kousei Hospital ( Site 2507)

Sendai, Miyagi, 981-0914, Japan

RECRUITING

Kansai Medical University Hospital ( Site 2503)

Hirakata, Osaka, 573-1191, Japan

RECRUITING

National Hospital Organization Ureshino Medical Center ( Site 2524)

Ureshino, Saga-ken, 843-0393, Japan

RECRUITING

Saitama Prefectural Cancer Center ( Site 2512)

Kitaadachi-gun, Saitama, 362-0806, Japan

RECRUITING

Cancer Institute Hospital of JFCR ( Site 2500)

Koto, Tokyo, 135-8550, Japan

RECRUITING

Toho University Omori Medical Center ( Site 2520)

Ōta-ku, Tokyo, 143-8541, Japan

RECRUITING

National Center for Global Health and Medicine ( Site 2516)

Shinjuku, Tokyo, 162-8655, Japan

RECRUITING

National Hospital Organization Yamaguchi Ube Medical Center ( Site 2523)

Ube, Yamaguchi, 755-0241, Japan

RECRUITING

Chiba University Hospital ( Site 2517)

Chiba, 260-8677, Japan

RECRUITING

National Hospital Organization Kyushu Medical Center ( Site 2509)

Fukuoka, 810-8563, Japan

RECRUITING

Niigata Cancer Center Hospital ( Site 2505)

Niigata, 951-8566, Japan

RECRUITING

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 2506)

Osaka, 541-8567, Japan

RECRUITING

Clínica San Antonio ( Site 0606)

Trujillo, La Libertad, 13008, Peru

RECRUITING

Clínicas AUNA Sede Chiclayo ( Site 0604)

Chiclayo, Lambayeque, 14001, Peru

RECRUITING

Oncosalud-Clinical Research ( Site 0600)

Lima, 15036, Peru

RECRUITING

Hospital Militar Central Coronel Luis Arias Schereiber ( Site 0602)

Lima, 15076, Peru

RECRUITING

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 1503)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

RECRUITING

Regionalny Szpital Specjalistyczny im. dr. Władyslawa Biegańskiego ( Site 1513)

Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300, Poland

RECRUITING

Szpital Specjalistyczny im. Henryka Klimontowicza ( Site 1507)

Gorlice, Lesser Poland Voivodeship, 38-300, Poland

COMPLETED

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie-Oncology Department ( Site 1515)

Krakow, Lesser Poland Voivodeship, 31-826, Poland

RECRUITING

Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 1510)

Poznań, Lower Silesian Voivodeship, 60-569, Poland

RECRUITING

Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 1523)

Warsaw, Masovian Voivodeship, 01-138, Poland

RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 1500)

Warsaw, Masovian Voivodeship, 02-781, Poland

RECRUITING

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1501)

Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

RECRUITING

Bialostockie Centrum Onkologii ( Site 1520)

Bialystok, Podlaskie Voivodeship, 15-027, Poland

RECRUITING

Szpital Wojewódzki w Koszalinie. ( Site 1517)

Poland, West Pomeranian Voivodeship, 75-581, Poland

RECRUITING

Centrul Medical Medicover Victoria ( Site 2000)

Bucharest, Bucharest, 010626, Romania

RECRUITING

Cardiomed SRL Cluj-Napoca ( Site 2002)

Cluj-Napoca, Cluj, 400015, Romania

RECRUITING

SC Radiotherapy Center Cluj SRL-Oncologie Medicala ( Site 2001)

Florești, Cluj, 407280, Romania

RECRUITING

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2004)

Craiova, Dolj, 200542, Romania

RECRUITING

Cabinet Medical Oncomed ( Site 2005)

Timișoara, Timiș County, 300239, Romania

RECRUITING

SC ONCO CARD SRL ( Site 2007)

Brasov, 500052, Romania

RECRUITING

Lotus-Med ( Site 2009)

Bucharest, 012292, Romania

RECRUITING

Clinica Polisano ( Site 2008)

Sibiu, 550253, Romania

RECRUITING

The Catholic University of Korea, Incheon St. Mary's Hospital ( Site 2106)

Bupyeong-gu, Incheon, 21431, South Korea

RECRUITING

Pusan National University Yangsan Hospital ( Site 2104)

Yangsan, Kyongsangnam-do, 50612, South Korea

RECRUITING

Pusan National University Hospital ( Site 2100)

Busan, Pusan-Kwangyokshi, 49241, South Korea

RECRUITING

Kyungpook National University Chilgok Hospital-Pulmonology ( Site 2102)

Deagu, Taegu-Kwangyokshi, 41404, South Korea

RECRUITING

Chungnam national university hospital-Department of Internal Medicine ( Site 2107)

Daejeon, Taejon-Kwangyokshi, 35015, South Korea

RECRUITING

Kyung Hee University Hospital ( Site 2101)

Seoul, 02447, South Korea

RECRUITING

Asan Medical Center ( Site 2105)

Seoul, 05505, South Korea

RECRUITING

Korea University Guro Hospital-Internal Medicine ( Site 2103)

Seoul, 08308, South Korea

RECRUITING

CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 1703)

Santiago de Compostela, Galicia, 15706, Spain

RECRUITING

Hospital Insular de Gran Canaria-Oncology ( Site 1701)

Las Palmas de Gran Canaria, Las Palmas, 35016, Spain

RECRUITING

Hospital Quirón Málaga ( Site 1704)

Málaga, Malaga, 29004, Spain

RECRUITING

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1700)

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Fundación Jiménez Díaz-Oncology & Hematology ( Site 1702)

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Virgen de Valme-Departamento de Oncologia ( Site 1705)

Seville, 41014, Spain

RECRUITING

National Taiwan University Cancer Center (NTUCC) ( Site 2209)

Taipei City, Taipei, 106, Taiwan

RECRUITING

Taoyuan General Hospital ( Site 2203)

Taoyuan City, Taoyuan, 33004, Taiwan

RECRUITING

Chang Gung Memorial Hospital at Kaohsiung ( Site 2207)

Kaohsiung City, 83301, Taiwan

RECRUITING

Taichung Veterans General Hospital ( Site 2204)

Taichung, 407, Taiwan

RECRUITING

National Cheng Kung University Hospital ( Site 2205)

Tainan, 704, Taiwan

RECRUITING

National Taiwan University Hospital-Oncology ( Site 2208)

Taipei, 10002, Taiwan

RECRUITING

Mackay Memorial Hospital-Chest Medicine ( Site 2201)

Taipei, 10449, Taiwan

RECRUITING

Chang Gung Medical Foundation-Linkou Branch-Clinic of Chest Medicine ( Site 2202)

Taoyuan, 333, Taiwan

RECRUITING

Faculty of Medicine Siriraj Hospital ( Site 2301)

Bangkoknoi, Bangkok, 10700, Thailand

RECRUITING

Bangkok Metropolitan Administration Medical College and Vajira Hospital ( Site 2300)

Dusit, Bangkok, 10300, Thailand

RECRUITING

Prapokklao Hospital ( Site 2306)

Mueang, Changwat Chanthaburi, 22000, Thailand

RECRUITING

Faculty of Medicine - Khon Kaen University ( Site 2305)

Muang, Changwat Khon Kaen, 40002, Thailand

RECRUITING

Lampang Cancer Hospital ( Site 2304)

Lampang, Changwat Lampang, 52000, Thailand

RECRUITING

Songklanagarind hospital ( Site 2303)

Hat Yai, Changwat Songkhla, 90110, Thailand

RECRUITING

Maharaj Nakorn Chiang Mai Hospital ( Site 2302)

Chiang Mai, 50200, Thailand

RECRUITING

Medipol Mega Universite Hastanesi-oncology ( Site 1811)

Stanbul, Istanbul, 34214, Turkey (Türkiye)

RECRUITING

Hacettepe Universite Hastaneleri-oncology hospital ( Site 1801)

Ankara, 06230, Turkey (Türkiye)

RECRUITING

Gazi Universitesi-Oncology ( Site 1804)

Ankara, 06560, Turkey (Türkiye)

RECRUITING

Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1800)

Ankara, 06800, Turkey (Türkiye)

RECRUITING

Izmir Atatürk Training and Research Hospital ( Site 1810)

Izmir, 35360, Turkey (Türkiye)

RECRUITING

Memorial Kayseri Hastanesi ( Site 1805)

Kayseri, 38010, Turkey (Türkiye)

RECRUITING

Mersin Sehir Eğitim ve Araştırma Hastanesi-Oncology ( Site 1808)

Mersin, 33240, Turkey (Türkiye)

RECRUITING

Samsun Medical Park Hastanesi-medical oncology ( Site 1806)

Samsun, 55200, Turkey (Türkiye)

RECRUITING

Cleveland Clinic Abu Dhabi ( Site 2650)

Abu Dhabi, Abu Dhabi Emirate, 112412, United Arab Emirates

COMPLETED

Burjeel Medical City ( Site 2600)

Abu Dhabi, Abu Dhabi Emirate, 92510, United Arab Emirates

COMPLETED

North West Cancer Centre ( Site 1908)

Londonderry, Derry and Strabane, BT47 6SB, United Kingdom

RECRUITING

Torbay Hospital ( Site 1906)

Torquay, Devon, TQ2 7AA, United Kingdom

RECRUITING

St Bartholomew's Hospital ( Site 1901)

London, London, City of, EC1A7BE, United Kingdom

RECRUITING

City Hospital, Nottingham University Hospitals NHS Trust-NCCTT ( Site 1911)

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; Carboplatin; Paclitaxel; 130-nm albumin-bound paclitaxel

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)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

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

Model Details: Participants are allocated to a single induction arm, then assigned randomly to one of 2 maintenance arms.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 20, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): January 12, 2029
• Study Completion (Estimated): February 12, 2031
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

CZ (4); IL (4); IE (1); US (20); ES (6); HU (6); IT (12); DE (5); RO (8); TU (8); FR (6); PL (10); TW (8); AU (4); GB (4); TH (7); CL (6); JP (28); PE (4); CA (5); AR (6); AE (2); BR (7); KR (8); CN (28); CO (5)