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RECRUITING

NCT06422143

PHASE3

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

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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).

Official title: Phase 3 Study of Pembrolizumab in Combination With Carboplatin/Taxane (Paclitaxel or Nab-paclitaxel) Followed by Pembrolizumab With or Without Maintenance MK-2870 in the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

851

Start Date

2024-06-10

Completion Date

2031-08-15

Last Updated

2026-10-29

Healthy Volunteers

Conditions

Non-small Cell Lung Cancer NSCLC

Interventions

BIOLOGICAL

Pembrolizumab

Intravenous (IV) infusion

BIOLOGICAL

sac-TMT

IV infusion

DRUG

Carboplatin

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.

DRUG

Paclitaxel

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.

DRUG

Nab-paclitaxel

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.

Inclusion Criteria: * 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 Exclusion Criteria: * 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. * Has known central nervous system (CNS) metastases/carcinomatous meningitis * Severe hypersensitivity (≥Grade 3) to study intervention and/or any of its excipients or to another biologic therapy * Active autoimmune disease that has required systemic treatment in the past 2 years (replacement therapy \[eg, thyroxine, insulin, or physiologic corticosteroid\] is allowed) * Has a history of (noninfectious)pneumonitis/ILD that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening * Active infection requiring systemic therapy * History of allogeneic tissue/solid organ transplant

Locations (217)

CARTI Cancer Center ( Site 0006)

Little Rock, Arkansas, United States

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

Burbank, California, United States

Sharp Memorial Hospital ( Site 9544)

San Diego, California, United States

Intermountain Health Cancer Center Lutheran Hospital ( Site 0119)

Golden, Colorado, United States

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

Grand Junction, Colorado, United States

Washington Hospital Center ( Site 0037)

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

Mid Florida Hematology and Oncology Center ( Site 0109)

Orange City, Florida, United States

Centricity Research Columbus Cancer Center ( Site 0111)

Columbus, Georgia, United States

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

Marietta, Georgia, United States

Southeastern Regional Medical Center ( Site 0004)

Newnan, Georgia, United States

University of Chicago Medical Center ( Site 0145)

Chicago, Illinois, United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor ( Site 9552)

Ypsilanti, Michigan, United States

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

Minneapolis, Minnesota, United States

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0035)

Hackensack, New Jersey, United States

Capital Health Medical Center - Hopewell ( Site 0034)

Pennington, New Jersey, United States

New Mexico Oncology Hematology Consultants Ltd. ( Site 0123)

Albuquerque, New Mexico, United States

University of New Mexico Comprehensive Cancer Center ( Site 0135)

Albuquerque, New Mexico, United States

St Luke's University Health Network ( Site 0017)

Bethlehem, Pennsylvania, United States

Thomas Jefferson University - Clinical Research Institute ( Site 0147)

Philadelphia, Pennsylvania, United States

Memorial Hermann Cancer Center ( Site 0015)

Houston, Texas, United States

Oncology Consultants P.A. ( Site 0124)

Houston, Texas, United States

Mays Cancer Center ( Site 0132)

San Antonio, Texas, United States

Instituto Alexander Fleming ( Site 0203)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Instituto de Investigaciones Clínicas Mar del Plata ( Site 0200)

Mar del Plata, Buenos Aires, Argentina

Instituto Médico Río Cuarto ( Site 0204)

Río Cuarto, Córdoba Province, Argentina

Fundacion Intecnus ( Site 0205)

Bariloche, Río Negro Province, Argentina

Sanatorio Parque ( Site 0201)

Rosario, Santa Fe Province, Argentina

Hospital Aleman-Oncology ( Site 0202)

Buenos Aires, Argentina

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

Linz, Upper Austria, Austria

Klinik Hietzing ( Site 0740)

Vienna, Austria

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

Vienna, Austria

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

Vienna, Austria

Hospital do Cancer de Pernambuco ( Site 0312)

Recife, Pernambuco, Brazil

Vencer Centro de Pesquisa Clínica ( Site 0309)

Teresina, Piauí, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceição ( Site 0300)

Porto Alegre, Rio Grande do Sul, Brazil

Instituto de Oncologia Saint Gallen ( Site 0304)

Santa Cruz do Sul, Rio Grande do Sul, Brazil

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

São José do Rio Preto, São Paulo, Brazil

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 0302)

São Paulo, Brazil

Hospital Paulistano ( Site 0307)

São Paulo, Brazil

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

Kingston, Ontario, Canada

Waterloo Regional Health Network (WRHN) ( Site 0153)

Kitchener, Ontario, Canada

St. Marys Hospital Center ( Site 0105)

Montreal, Quebec, Canada

McGill University Health Centre ( Site 0103)

Montreal, Quebec, Canada

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

Trois-Rivières, Quebec, Canada

Centro de Investigación del Maule ( Site 0419)

Talca, Maule Region, Chile

Fundación Arturo López Pérez ( Site 0409)

Santiago, Region M. de Santiago, Chile

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

Santiago, Region M. de Santiago, Chile

Bradfordhill-Clinical Area ( Site 0407)

Santiago, Region M. de Santiago, Chile

ONCOCENTRO APYS-ACEREY ( Site 0400)

Viña del Mar, Valparaiso, Chile

Bradford Hill Norte ( Site 0420)

Antofagasta, Chile

Beijing Cancer Hospital ( Site 2411)

Beijing, Beijing Municipality, China

Beijing Cancer hospital-intrathoratic deparmtment II ( Site 2410)

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital ( Site 2412)

Beijing, Beijing Municipality, China

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

Chongqing, Chongqing Municipality, China

Fujian Provincial Cancer Hospital ( Site 2419)

Fuzhou, Fujian, China

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

Xiamen, Fujian, China

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

Guangzhou, Guangdong, China

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

Guangzhou, Guangdong, China

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

Harbin, Heilongjiang, China

Henan Cancer Hospital-Pneumology department ( Site 2423)

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

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

Changsha, Hunan, China

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

Huai'an, Jiangsu, China

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

Yangzhou, Jiangsu, China

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

Nanchang, Jiangxi, China

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

Nanchang, Jiangxi, China

Jilin Province Tumor Hospital-GCP office ( Site 2413)

Changchun, Jilin, China

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

Changchun, Jilin, China

Shanghai East Hospital ( Site 2428)

Shanghai, Shanghai Municipality, China

Shanghai Pulmonary Hospital ( Site 2427)

Shanghai, Shanghai Municipality, China

West China Hospital, Sichuan University ( Site 2422)

Chengdu, Sichuan, China

Sichuan Cancer hospital. ( Site 2421)

Chengdu, Sichuan, China

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

Ürümqi, Xinjiang, China

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

Hangzhou, Zhejiang, China

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

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital-Breast Oncology ( Site 2408)

Hangzhou, Zhejiang, China

Taizhou Hospital of Zhejiang Province ( Site 2430)

Taizhou, Zhejiang, China

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

Wenzhou, Zhejiang, China

Centro Cancerológico del Caribe (CECAC) ( Site 0509)

Barranquilla, Atlántico, Colombia

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

Bogotá, Bogota D.C., Colombia

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

Valledupar, Cesar Department, Colombia

Oncologos del Occidente ( Site 0504)

Pereira, Risaralda Department, Colombia

Fundación Valle del Lili-Oncology CIC ( Site 0505)

Cali, Valle del Cauca Department, Colombia

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

Brno, Brno-mesto, Czechia

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

Ostrava-Vitkovice, Ostrava Mesto, Czechia

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

Pardubice, Pardubice Region, Czechia

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

Olomouc, Czechia

Clinique Clairval ( Site 0904)

Marseille, Bouches-du-Rhone, France

Hôpital Robert Schuman ( Site 0907)

Vantoux, Lorraine, France

Institut de Cancérologie de l'Ouest ( Site 0908)

Angers, Maine-et-Loire, France

Sainte Catherine Institut du Cancer Avignon Provence ( Site 0902)

Avignon, Vaucluse, France

CHD Vendee ( Site 0901)

La Roche-sur-Yon, Vendee, France

Hôpital Saint-Louis ( Site 0906)

Paris, France

GEFOS Gesellschaft f. onkologische Studien ( Site 1005)

Dortmund, North Rhine-Westphalia, Germany

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

Essen, North Rhine-Westphalia, Germany

Universitätsklinikum Schleswig-Holstein-Pneumologie ( Site 1000)

Lübeck, Schleswig-Holstein, Germany

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

Gera, Thuringia, Germany

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

Berlin, Germany

Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 1100)

Kecskemét, Bács-Kiskun county, Hungary

And 117 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (217)