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Purpose

The primary objective of the study is to compare sacituzumab tirumotecan combined with pembrolizumab to pembrolizumab alone with respect to overall survival (OS). The primary hypothesis is that the combination of sacituzumab tirumotecan and pembrolizumab is superior to pembrolizumab alone with respect to OS. All participants who have completed the first course of pembrolizumab may be eligible for up to an additional 9 cycles of pembrolizumab monotherapy if there is blinded independent central review (BICR)-verified progressive disease by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1) after initial treatment.

Condition

Eligibility

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

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC - Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy - Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory - An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization. - A life expectancy of at least 3 months. - Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART)

Exclusion Criteria

  • Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements. - Has Grade ≥2 peripheral neuropathy. - 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 clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea). - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention. - Received prior systemic anticancer therapy for their metastatic NSCLC. - Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor Note: Prior treatment with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC. - Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. - Received radiation therapy to the lung that is >30 Gy 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. Administration of killed vaccines are allowed. - Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy - Known additional malignancy that is progressing or has required active treatment within the past 3 years. - Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. - Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary. - Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy. - Active autoimmune disease that has required systemic treatment in the past 2 years. - History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD. - Active infection requiring systemic therapy - Concurrent active Hepatitis B and Hepatitis C virus infection. - Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease. - History of allogeneic tissue/solid organ transplant. - Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Pembrolizumab + Sacituzumab tirumotecan 		Participants receive sacituzumab tirumotecan via intravenous (IV) infusion on Days 1, 15 and 29 of each 6-week cycle + 400 mg Pembrolizumab every 6 weeks (q6w) via IV infusion on Day 1 of each 6-week cycle for 18 cycles. Additionally, participants receive diphenhydramine (or equivalent), an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to the first 4 infusions of sacituzumab tirumotecan. At subsequent infusions, the H2 antagonist and dexamethasone are optional, at the discretion of the investigator.
  • Biological: Sacituzumab tirumotecan
    IV infusion
    Other names:
    • SKB264
    • MK-2870
  • Biological: Pembrolizumab
    IV infusion
    Other names:
    • MK-3475
    • KEYTRUDA®
    • SCH 900475
  • Drug: Supportive care measures
    Participants are allowed to take supportive care measures at the discretion of the investigator. Prophylactic supportive care measures may include but are not limited to antiemetic agents, antidiarrheal agents, granulocyte and erythroid growth factors, and blood transfusions
Active Comparator
Pembrolizumab 		Participants receive 400 mg Pembrolizumab via IV infusion q6w on Day 1 of each 6-week cycle for 18 cycles
  • Biological: Sacituzumab tirumotecan
    IV infusion
    Other names:
    • SKB264
    • MK-2870
  • Biological: Pembrolizumab
    IV infusion
    Other names:
    • MK-3475
    • KEYTRUDA®
    • SCH 900475
  • Drug: Supportive care measures
    Participants are allowed to take supportive care measures at the discretion of the investigator. Prophylactic supportive care measures may include but are not limited to antiemetic agents, antidiarrheal agents, granulocyte and erythroid growth factors, and blood transfusions

Recruiting Locations

Mayo Clinic in Arizona - Phoenix ( Site 0147)
Phoenix, Arizona 85054
Contact:
Study Coordinator
480-342-4800

Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130)
Burbank, California 91505
Contact:
Study Coordinator
818-840-0921

Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132)
Grand Junction, Colorado 81501
Contact:
Study Coordinator
970-298-7638

Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133)
Jacksonville, Florida 32224
Contact:
Study Coordinator
904-953-9945

The University of Louisville, James Graham Brown Cancer Center ( Site 0121)
Louisville, Kentucky 40202
Contact:
Study Coordinator
502-562-3919

New England Cancer Specialists ( Site 0143)
Westbrook, Maine 04092
Contact:
Study Coordinator
207-303-3424

Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115)
Minneapolis, Minnesota 55407
Contact:
Study Coordinator
651-241-7025

Mayo Clinic - Rochester ( Site 0148)
Rochester, Minnesota 55905
Contact:
Study Coordinator
507-538-1665

Hattiesburg Clinic Hematology/Oncology ( Site 0104)
Hattiesburg, Mississippi 39401
Contact:
Study Coordinator
601-261-1700

Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134)
Reno, Nevada 89502
Contact:
Study Coordinator
775-982-5050

Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117)
Corvallis, Oregon 97330
Contact:
Study Coordinator
541-768-4950

More Details

NCT ID
NCT06170788
Status
Recruiting
Sponsor
Merck Sharp & Dohme LLC

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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