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)

Purpose

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).

Condition

  • Non Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease - 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a multi site study
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pembrolizumab + Sacituzumab tirumotecan 		Participants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 12 doses (~24 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (~42 weeks).
  • Biological: Sacituzumab tirumotecan
    Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks
    Other names:
    • MK-2870
    • sac-TMT
    • SKB264
  • Biological: Pembrolizumab
    Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks
    Other names:
    • MK-3475
  • Drug: Rescue medication
    Participants are allowed to take rescue medication to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.
Active Comparator
Pembrolizumab 		Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (~42 weeks).
  • Biological: Sacituzumab tirumotecan
    Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks
    Other names:
    • MK-2870
    • sac-TMT
    • SKB264
  • Biological: Pembrolizumab
    Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks
    Other names:
    • MK-3475
  • Drug: Cisplatin
    Cisplatin is administered as 75 mg/m2 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/m2 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/m2 or 1250 mg/m2 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/m2 or 200 mg/m2 IV infusion q3w for up to 12 weeks as background treatment.
  • Drug: Rescue medication
    Participants are allowed to take rescue medication to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.

Recruiting Locations

UAMS Winthrop P. Rockefeller Cancer Institute ( Site 0060)
Little Rock, Arkansas 72205
Contact:
Study Coordinator
601-278-6499

Highlands Oncology Group-Research Department ( Site 0062)
Springdale, Arkansas 72762
Contact:
Study Coordinator
479-334-2562

Beverly Hills Cancer Center ( Site 0070)
Beverly Hills, California 90211
Contact:
Study Coordinator
310-432-8933

The Angeles Clinic and Research Institute ( Site 0040)
Los Angeles, California 90025
Contact:
Study Coordinator
310-582-7900

The Angeles Clinic and Research Institute- A Cedars-Sinai Affiliate ( Site 0079)
Los Angeles, California 90025
Contact:
Study Coordinator
310-582-7900

UCLA Clinical & Translational Research Center (CTRC) ( Site 0033)
Los Angeles, California 90095
Contact:
Study Coordinator
424-325-9070

Hoag Memorial Hospital Presbyterian ( Site 0096)
Newport Beach, California 92663
Contact:
Study Coordinator
949-764-4060

San Francisco Oncology Associates ( Site 0066)
San Francisco, California 94115
Contact:
Study Coordinator
415-600-1102

Stamford Hospital ( Site 0083)
Stamford, Connecticut 06902
Contact:
Study Coordinator
203-358-8879

Mayo Clinic in Florida ( Site 0014)
Jacksonville, Florida 32224
Contact:
Study Coordinator
904-953-3570

Mount Sinai Cancer Center ( Site 0038)
Miami Beach, Florida 33140
Contact:
Study Coordinator
305-674-2625

Mid Florida Hematology and Oncology Center ( Site 0018)
Orange City, Florida 32763
Contact:
Study Coordinator
386-960-7070

Emory University School of Medicine-Phase I ( Site 0056)
Atlanta, Georgia 30322
Contact:
Study Coordinator
404-778-1900

Northside Hospital ( Site 0055)
Atlanta, Georgia 30342
Contact:
Study Coordinator
404-851-8000

Southeastern Regional Medical Center ( Site 0065)
Newnan, Georgia 30265
Contact:
Study Coordinator
770-400-6000

Lewis Cancer and Research Pavilion ( Site 0063)
Savannah, Georgia 31405
Contact:
Study Coordinator
912-819-5704

Archbold Cancer Center ( Site 0071)
Thomasville, Georgia 31792
Contact:
Study Coordinator
229-584-5417

Parkview Research Center at Parkview Regional Medical Center ( Site 0089)
Fort Wayne, Indiana 46845
Contact:
Study Coordinator
260-266-6626

Indiana University Health Arnett Cancer Center ( Site 0076)
Lafayette, Indiana 47904
Contact:
Study Coordinator
765-838-6885

Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0061)
Edgewood, Kentucky 41017
Contact:
Study Coordinator
859-301-4736

LSU Health Baton Rouge North Clinic ( Site 4003)
Baton Rouge, Louisiana 70805
Contact:
Study Coordinator
225-765-7956

Our Lady of the Lake Physician Group-Medical Oncology ( Site 0080)
Baton Rouge, Louisiana 70808
Contact:
Study Coordinator
225-765-7956

New England Cancer Specialists ( Site 0095)
Westbrook, Maine 04092
Contact:
Study Coordinator
207-303-3300

Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027)
Minneapolis, Minnesota 55407
Contact:
Study Coordinator
888-425-5462

Mayo Clinic - Rochester ( Site 0073)
Rochester, Minnesota 55905
Contact:
Study Coordinator
904-953-1050

Mercy South - David M Sindelar Cancer Center ( Site 0098)
St Louis, Missouri 63128
Contact:
Study Coordinator
314-525-4928

Mercy Research - David C. Pratt Cancer Center ( Site 0006)
St Louis, Missouri 63141
Contact:
Study Coordinator
314-251-4400

Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037)
Reno, Nevada 89502
Contact:
Study Coordinator
775-982-5050

Atlantic Health Morristown Medical Center ( Site 0077)
Morristown, New Jersey 07960
Contact:
Study Coordinator
973-971-7000

Cayuga Medical Center ( Site 0086)
Ithaca, New York 14850
Contact:
Study Coordinator
607-277-4341

Stony Brook University-Cancer Center ( Site 0054)
Stony Brook, New York 11794
Contact:
Study Coordinator
631-372-7212

White Plains Hospital ( Site 0091)
White Plains, New York 10601
Contact:
Study Coordinator
914-681-0600

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0057)
Fargo, North Dakota 58102
Contact:
Study Coordinator
701-234-6161

Hightower Clinical, LLC ( Site 0084)
Oklahoma City, Oklahoma 73102
Contact:
Study Coordinator
405-479-8331

Oregon Health and Science University ( Site 0052)
Portland, Oregon 97239
Contact:
Study Coordinator
503-494-0283

Penn State Milton S. Hershey Medical Center-Penn State Cancer Institute ( Site 0059)
Hershey, Pennsylvania 17033
Contact:
Study Coordinator
717-531-0003

Lancaster General Hospital - Ann B Barshinger Cancer Institute ( Site 0068)
Lancaster, Pennsylvania 17601
Contact:
Study Coordinator
717-544-0511

Saint Joseph's Candler Health System ( Site 4010)
Bluffton, South Carolina 29910
Contact:
Study Coordinator
912-819-5704

Medical University of South Carolina-Hollings Cancer Center ( Site 0045)
Charleston, South Carolina 29425
Contact:
Study Coordinator
843-792-4271

Sanford Cancer Center ( Site 0053)
Sioux Falls, South Dakota 57104
Contact:
Study Coordinator
605-328-8800

Avera Cancer Institute- Research ( Site 0090)
Sioux Falls, South Dakota 57105
Contact:
Study Coordinator
605-322-3295

University of Tennessee Medical Center Knoxville ( Site 0082)
Knoxville, Tennessee 37920
Contact:
Study Coordinator
865-305-9000

Huntsman Cancer Institute ( Site 0042)
Salt Lake City, Utah 84112-5500
Contact:
Study Coordinator
801-587-7000

More Details

NCT ID
NCT06312137
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

Toll Free Number
1-888-577-8839
Trialsites@msd.com

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center