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Phase 3Recruiting

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)

Sponsored by Merck Sharp & Dohme LLC

About this study

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).

Where this study is enrolling (45)

  • Highlands Oncology Group-Research Department ( Site 0062)

    Springdale, Arkansas

    Call 479-334-2562

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  • UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)

    Little Rock, Arkansas

    Call 601-278-6499

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

    Los Angeles, California

    Call 424-325-9070

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

    Orange, California

    Call 714-734-6220

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  • Hoag Memorial Hospital Presbyterian ( Site 0096)

    Newport Beach, California

    Call 949-764-4060

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Show all 45 locations

  • Beverly Hills Cancer Center ( Site 0070)

    Beverly Hills, California

    Call 310-432-8933

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  • San Francisco Oncology Associates ( Site 0066)

    San Francisco, California

    Call 415-600-1102

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  • Stamford Hospital ( Site 0083)

    Stamford, Connecticut

    Call 203-358-8879

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  • Mount Sinai Cancer Center ( Site 0038)

    Miami Beach, Florida

    Call 305-674-2625

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  • Mayo Clinic in Florida ( Site 0014)

    Jacksonville, Florida

    Call 904-953-3570

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  • Mid Florida Hematology and Oncology Center ( Site 0018)

    Orange City, Florida

    Call 386-960-7070

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

    Atlanta, Georgia

    I'm interested

  • Northside Hospital ( Site 0055)

    Atlanta, Georgia

    Call 404-851-8000

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  • Piedmont Atlanta Hospital ( Site 4000)

    Atlanta, Georgia

    Call 404.605.5000

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  • Southeastern Regional Medical Center ( Site 0065)

    Newnan, Georgia

    Call 770-400-6000

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  • Lewis Cancer and Research Pavilion ( Site 0063)

    Savannah, Georgia

    Call 912-819-5704

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  • Archbold Cancer Center ( Site 0071)

    Thomasville, Georgia

    Call 229-584-5417

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  • Accellacare of Duly ( Site 4005)

    Lisle, Illinois

    Call 630-545-7760

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  • North Shore University Health System ( Site 4014)

    Evanston, Illinois

    I'm interested

  • Indiana University Health Arnett Cancer Center ( Site 0076)

    Lafayette, Indiana

    Call 765-838-6885

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

    Fort Wayne, Indiana

    Call 260-266-6626

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

    Edgewood, Kentucky

    Call 859-301-4736

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

    Baton Rouge, Louisiana

    Call 225-765-7956

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  • LSU Health Baton Rouge North Clinic ( Site 4003)

    Baton Rouge, Louisiana

    Call 225-765-7956

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  • New England Cancer Specialists ( Site 0095)

    Westbrook, Maine

    Call 207-303-3300

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  • Mayo Clinic - Rochester ( Site 0073)

    Rochester, Minnesota

    Call 904-953-1050

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

    Minneapolis, Minnesota

    Call 888-425-5462

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

    St Louis, Missouri

    Call 314-525-4928

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

    St Louis, Missouri

    Call 314-251-4400

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

    Reno, Nevada

    Call 775-982-5050

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  • Atlantic Health Morristown Medical Center ( Site 0077)

    Morristown, New Jersey

    Call 973-971-7000

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  • White Plains Hospital ( Site 0091)

    White Plains, New York

    Call 914-681-0600

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  • Cayuga Medical Center ( Site 0086)

    Ithaca, New York

    Call 607-277-4341

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  • University Hospital at Stony Brook ( Site 0054)

    Stony Brook, New York

    Call 631-372-7212

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

    Fargo, North Dakota

    Call 701-234-6161

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  • Hightower Clinical, LLC ( Site 0084)

    Oklahoma City, Oklahoma

    Call 405-479-8331

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  • Oregon Health and Science University ( Site 0052)

    Portland, Oregon

    Call 503-494-0283

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

    Lancaster, Pennsylvania

    Call 717-544-0511

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

    Hershey, Pennsylvania

    Call 717-531-0003

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

    Charleston, South Carolina

    Call 843-792-4271

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  • Saint Joseph's Candler Health System ( Site 4010)

    Bluffton, South Carolina

    Call 912-819-5704

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  • Avera Cancer Institute- Research ( Site 0090)

    Sioux Falls, South Dakota

    Call 605-322-3295

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  • Sanford Cancer Center ( Site 0053)

    Sioux Falls, South Dakota

    Call 605-328-8800

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  • University of Tennessee Medical Center Knoxville ( Site 0082)

    Knoxville, Tennessee

    Call 865-305-9000

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  • Huntsman Cancer Institute ( Site 0042)

    Salt Lake City, Utah

    Call 801-587-7000

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Who can participate

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

  • ✕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

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.