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OncoMatch/Clinical Trials/NCT06170788

Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)

Is NCT06170788 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Sacituzumab tirumotecan and Pembrolizumab for non-small cell lung cancer (nsclc).

Phase 3RecruitingMerck Sharp & Dohme LLCNCT06170788Data as of May 2026

Treatment: Sacituzumab tirumotecan · Pembrolizumab · Supportive care measuresThe 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.

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Extracted eligibility criteria

Cancer type

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: EGFR wild-type

Confirmation that epidermal growth factor receptor- (EGFR-)...directed therapy is not indicated as primary therapy

Required: ALK wild-type

Confirmation that...anaplastic lymphoma kinase- (ALK-)...directed therapy is not indicated as primary therapy

Required: ROS1 wild-type

Confirmation that...proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy

Required: PD-L1 (CD274) overexpression (TPS ≥ 50%)

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

Disease stage

Metastatic disease required

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: systemic anticancer therapy

Received prior systemic anticancer therapy for their metastatic NSCLC

Cannot have received: anti-PD-1 therapy

Exception: 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 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

Cannot have received: systemic anticancer therapy

Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization

Cannot have received: radiation therapy

Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention

Cannot have received: radiation therapy

Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Mayo Clinic in Arizona - Phoenix ( Site 0147) · Phoenix, Arizona
  • Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center ( Site 0130) · Burbank, California
  • Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0132) · Grand Junction, Colorado
  • Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0133) · Jacksonville, Florida
  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0106) · Marietta, Georgia

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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