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RECRUITING

NCT06312137

PHASE3

A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

Summary

This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).

Official title: A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

780

Start Date

2024-04-03

Completion Date

2034-10-23

Last Updated

2026-10-15

Healthy Volunteers

Conditions

Non Small Cell Lung Cancer

Interventions

BIOLOGICAL

Sacituzumab tirumotecan

Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks

BIOLOGICAL

Pembrolizumab

Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks

DRUG

Cisplatin

Cisplatin is administered as 75 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase

DRUG

Pemetrexed

Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC.

DRUG

Gemcitabine

Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m\^2 or 1250 mg/m\^2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC.

DRUG

Carboplatin

Carboplatin will be administered in the neoadjuvant phase as AUC 5 mg/mL/min or AUC 6 mg/mL/min IV infusion q3w for up to 12 weeks as background treatment.

DRUG

Paclitaxel

Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m\^2 or 200 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment.

DRUG

Rescue medication

Participants are permitted to take rescue medications to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. Rescue medications include antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and granulocyte colony-stimulating factor. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.

The key inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement \[N2\]) per AJCC eighth edition guidelines * Has confirmation that either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-directed therapy is not indicated as primary therapy * Is able to undergo surgery based on opinion of investigator after consultation with surgeon * Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy * Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology. * Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period * Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization * Participants who have 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 * 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 at screening * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention Exclusion Criteria: * Has one of the following tumor locations/types: * NSCLC involving the superior sulcus * Large cell neuro-endocrine cancer (LCNEC) * Sarcomatoid tumor * Diagnosis of SCLC or, for mixed tumors, presence of small cell elements * Has Grade ≥2 peripheral neuropathy * Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing * Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease * 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 QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention * Has received prior neoadjuvant therapy for their current NSCLC diagnosis * Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention * Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has a known additional malignancy that is progressing or has required active treatment within the past 5 years * Has an active autoimmune disease that has required systemic treatment in the past 2 years * Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis, has current ILD/pneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening * Has an active infection requiring systemic therapy * Is an HIV-infected participant with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection * Has a history of allogeneic tissue/solid organ transplant * Has not adequately recovered from major surgery or have ongoing surgical complications * Severe hypersensitivity (≥Grade 3) to study intervention, any of its excipients, and/or to another biologic therapy

Locations (270)

UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)

Little Rock, Arkansas, United States

Highlands Oncology Group-Research Department ( Site 0062)

Springdale, Arkansas, United States

Beverly Hills Cancer Center ( Site 0070)

Beverly Hills, California, United States

The Angeles Clinic and Research Institute ( Site 0040)

Los Angeles, California, United States

The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079)

Los Angeles, California, United States

UCLA Clinical & Translational Research Center (CTRC) ( Site 0033)

Los Angeles, California, United States

Hoag Memorial Hospital Presbyterian ( Site 0096)

Newport Beach, California, United States

St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 4002)

Orange, California, United States

San Francisco Oncology Associates ( Site 0066)

San Francisco, California, United States

Stamford Hospital ( Site 0083)

Stamford, Connecticut, United States

Mayo Clinic in Florida ( Site 0014)

Jacksonville, Florida, United States

Mount Sinai Cancer Center ( Site 0038)

Miami Beach, Florida, United States

Mid Florida Hematology and Oncology Center ( Site 0018)

Orange City, Florida, United States

Piedmont Atlanta Hospital ( Site 4000)

Atlanta, Georgia, United States

Emory University School of Medicine-Phase I ( Site 0056)

Atlanta, Georgia, United States

Northside Hospital ( Site 0055)

Atlanta, Georgia, United States

Centricity Research Columbus Cancer Center ( Site 0005)

Columbus, Georgia, United States

Southeastern Regional Medical Center ( Site 0065)

Newnan, Georgia, United States

Lewis Cancer and Research Pavilion ( Site 0063)

Savannah, Georgia, United States

Archbold Cancer Center ( Site 0071)

Thomasville, Georgia, United States

Edward-Elmhurst Healthcare, Elmhurst Hospital-Nancy W. Knowles Cancer Center ( Site 0017)

Elmhurst, Illinois, United States

North Shore University Health System ( Site 4014)

Evanston, Illinois, United States

Accellacare of Duly ( Site 4005)

Lisle, Illinois, United States

Edward-Elmhurst Healthcare, Edward Hospital-Edward Cancer Center ( Site 0078)

Naperville, Illinois, United States

Parkview Research Center at Parkview Regional Medical Center ( Site 0089)

Fort Wayne, Indiana, United States

Indiana University Health Arnett Cancer Center ( Site 0076)

Lafayette, Indiana, United States

Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0061)

Edgewood, Kentucky, United States

LSU Health Baton Rouge North Clinic ( Site 4003)

Baton Rouge, Louisiana, United States

Our Lady of the Lake Physician Group-Medical Oncology ( Site 0080)

Baton Rouge, Louisiana, United States

New England Cancer Specialists ( Site 0095)

Westbrook, Maine, United States

Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027)

Minneapolis, Minnesota, United States

Mayo Clinic - Rochester ( Site 0073)

Rochester, Minnesota, United States

Mercy South - David M Sindelar Cancer Center ( Site 0098)

St Louis, Missouri, United States

Mercy Research - David C. Pratt Cancer Center ( Site 0006)

St Louis, Missouri, United States

Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037)

Reno, Nevada, United States

Atlantic Health Morristown Medical Center ( Site 0077)

Morristown, New Jersey, United States

Cayuga Medical Center ( Site 0086)

Ithaca, New York, United States

University Hospital at Stony Brook ( Site 0054)

Stony Brook, New York, United States

White Plains Hospital ( Site 0091)

White Plains, New York, United States

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0057)

Fargo, North Dakota, United States

Hightower Clinical, LLC ( Site 0084)

Oklahoma City, Oklahoma, United States

Oregon Health and Science University ( Site 0052)

Portland, Oregon, United States

Penn State Milton S. Hershey Medical Center-Penn State Cancer Institute ( Site 0059)

Hershey, Pennsylvania, United States

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0068)

Lancaster, Pennsylvania, United States

Saint Joseph's Candler Health System ( Site 4010)

Bluffton, South Carolina, United States

Medical University of South Carolina-Hollings Cancer Center ( Site 0045)

Charleston, South Carolina, United States

Sanford Cancer Center ( Site 0053)

Sioux Falls, South Dakota, United States

Avera Cancer Institute- Research ( Site 0090)

Sioux Falls, South Dakota, United States

University of Tennessee Medical Center Knoxville ( Site 0082)

Knoxville, Tennessee, United States

Millennium Research & Clinical Development ( Site 0039)

Houston, Texas, United States

Huntsman Cancer Institute ( Site 0042)

Salt Lake City, Utah, United States

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Británico de Buenos Aires-Oncology ( Site 0207)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Sanatorio Británico-Clinical Oncology Department ( Site 0206)

Rosario, Santa Fe Province, Argentina

Sanatorio Parque ( Site 0205)

Rosario, Santa Fe Province, Argentina

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 0217)

San Miguel de Tucumán, Tucumán Province, Argentina

Hospital Aleman-Oncology ( Site 0202)

Buenos Aires, Argentina

Hospital Privado Universitario de Córdoba-Hematology and Oncology ( Site 0204)

Córdoba, Argentina

Westmead Hospital ( Site 0701)

Westmead, New South Wales, Australia

The Prince Charles Hospital ( Site 0700)

Brisbane, Queensland, Australia

Fiona Stanley Hospital-Medical Oncology ( Site 0705)

Murdoch, Western Australia, Australia

Medizinische Universitaet Innsbruck-Department for Internal Medicine V ( Site 1403)

Innsbruck, Tyrol, Austria

Ordensklinikum Linz GmbH Elisabethinen-Department of Pneumology ( Site 1402)

Linz, Upper Austria, Austria

Standort Penzing der Klinik Ottakring-Abteilung für Atemwegs-und Lungenkrankheiten ( Site 1401)

Vienna, Austria

Klinik Floridsdorf-Abteilung für Innere Medizin und Pneumologie ( Site 1400)

Vienna, Austria

Antwerp University Hospital-Thoracic Oncology ( Site 1503)

Edegem, Antwerpen, Belgium

Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godi ( Site 1502)

Yvoir, Namur, Belgium

VITAZ ( Site 1500)

Sint-Niklaas, Oost-Vlaanderen, Belgium

Liga Norte Riograndense Contra o Câncer ( Site 0301)

Natal, Rio Grande do Norte, Brazil

Irmandade da Santa Casa de Misericórdia de Porto Alegre ( Site 0303)

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceição ( Site 0302)

Porto Alegre, Rio Grande do Sul, Brazil

Instituto de Oncologia Saint Gallen ( Site 0319)

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0304)

Barretos, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0313)

São José do Rio Preto, São Paulo, Brazil

ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO ( Site 0305)

São Paulo, Brazil

Centre Intégré de Santé et de Services Sociaux de la Montérégie-Centre ( Site 0100)

Greenfield Park, Quebec, Canada

Centre Hospitalier de l'Université de Montréal ( Site 0104)

Montreal, Quebec, Canada

St. Marys Hospital Center ( Site 0107)

Montreal, Quebec, Canada

McGill University Health Centre ( Site 0105)

Montreal, Quebec, Canada

FALP-UIDO ( Site 0401)

Providencia, Region M. de Santiago, Chile

Centro de Estudios Clínicos SAGA-CECSAGA ( Site 0404)

Santiago, Region M. de Santiago, Chile

Clínica RedSalud Vitacura ( Site 0412)

Santiago, Region M. de Santiago, Chile

Bradfordhill-Clinical Area ( Site 0400)

Santiago, Region M. de Santiago, Chile

ONCOCENTRO APYS-ACEREY ( Site 0410)

Viña del Mar, Valparaiso, Chile

Beijing Cancer hospital-Thoracic Surgery department I ( Site 1301)

Beijing, Beijing Municipality, China

Beijing Peking Union Medical College Hospital-Thoracic surgery department ( Site 1302)

Beijing, Beijing Municipality, China

Peking University People's Hospital ( Site 1300)

Beijing, Beijing Municipality, China

Fujian Cancer Hospital-oncology department ( Site 1314)

Fuzhou, Fujian, China

The First Affiliated Hospital of Guangzhou Medical University-thoracic surgery department ( Site 1320)

Guangzhou, Guangdong, China

Southern Medical University Nanfang Hospital-Thoracic surgery department ( Site 1313)

Guangzhou, Guangdong, China

Henan Cancer Hospital-henan cancer hospital ( Site 1316)

Zhengzhou, Henan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology-Thoracic Surgery ( Site 1306)

Wuhan, Hubei, China

Hubei Cancer Hospital ( Site 1308)

Wuhan, Hubei, China

Xiangya Hospital Central South University-Thoracic surgery ( Site 1311)

Changsha, Hunan, China

Hunan Cancer Hospital ( Site 1312)

Changsha, Hunan, China

Nanjing First Hospital ( Site 1310)

Nanjing, Jiangsu, China

The First Affiliated Hospital of Soochow University-Thoracic Surgery Department ( Site 1318)

Suzhou, Jiangsu, China

The First affiliated hospital of Nanchang University (Xianghu campus) ( Site 1330)

Nanchang, Jiangxi, China

The First Hospital of Jilin University ( Site 1324)

Changchun, Jilin, China

The Second Affiliated Hospital of Air Force Medical University ( Site 1332)

Xi'an, Shaanxi, China

And 170 more locations on ClinicalTrials.gov

Clinical Research Directory

A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (270)