Recruiting
Phase 3

Sacituzumab & Pembrolizumab

Sponsor:

Merck Sharp & Dohme LLC

Code:

NCT06170788

Conditions

Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sacituzumab tirumotecan

Pembrolizumab

Supportive care measures

Study Details

Brief summary:

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.

Conditions

Non-small Cell Lung Cancer (NSCLC)

Study ID

NCT06170788

Start date

Dec 15, 2023

Status verified date

Sep, 2026

Completion date

May 27, 2030

Anticipated

Primary completion date

Jan 25, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

614 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Pembrolizumab

Participants receive 400 mg Pembrolizumab via IV infusion q6w on Day 1 of each 6-week cycle for 18 cycles

Interventions

Sacituzumab tirumotecan

IV infusion

Pembrolizumab

IV infusion

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

Primary outcome measure

  • Overall Survival (OS) [ Time Frame: Up to approximately 49 months ]

Central Contacts and Locations

Central contacts

Toll Free Number

1-888-577-8839Trialsites@msd.com

Locations

Mayo Clinic in Arizona - Phoenix ( Site 0147)

Recruiting

Phoenix, Arizona, United States, 85054

Contacts

Study Coordinator

480-342-4800

Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130)

Recruiting

Burbank, California, United States, 91505

Contacts

Study Coordinator

818-840-0921

Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132)

Recruiting

Grand Junction, Colorado, United States, 81501

Contacts

Study Coordinator

970-298-7638

Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133)

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Study Coordinator

904-953-9945

New England Cancer Specialists ( Site 0143)

Recruiting

Westbrook, Maine, United States, 04092

Contacts

Study Coordinator

207-303-3424

Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0115)

Recruiting

Minneapolis, Minnesota, United States, 55407

Contacts

Study Coordinator

651-241-7025

Mayo Clinic - Rochester ( Site 0148)

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Study Coordinator

507-538-1665

Hattiesburg Clinic Hematology/Oncology ( Site 0104)

Recruiting

Hattiesburg, Mississippi, United States, 39401

Contacts

Study Coordinator

601-261-1700

Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0134)

Recruiting

Reno, Nevada, United States, 89502

Contacts

Study Coordinator

775-982-5050

Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0117)

Recruiting

Corvallis, Oregon, United States, 97330

Contacts

Study Coordinator

541-768-4950

William Osler Health System ( Site 0203)

Recruiting

Brampton, Ontario, Canada, L6R 3J7

Contacts

Study Coordinator

905-494-2120

Trillium Health Partners - Credit Valley Hospital ( Site 0202)

Recruiting

Mississauga, Ontario, Canada, L5M 2N1

Contacts

Study Coordinator

905-813-1100x4299

More Information

Sponsor

Merck Sharp & Dohme LLC

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Programmed Cell Death-1 (PD1, PD-1)
  • Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
  • Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Merck Sharp & Dohme LLC on 2026-09-03.