Sacituzumab Tirumotecan (MK-2870) Versus Chemotherapy in Previously Treated Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations or Other Genomic Alterations (MK-2870-004)
The purpose of this study is to evaluate sacituzumab tirumotecan versus chemotherapy (docetaxel or pemetrexed) for the treatment of previously-treated non-small cell lung cancer (NSCLC) with exon 19del or exon 21 L858R EGFR mutations (hereafter referred to as EGFR mutations or EGFR-mutated) or any of the follow genomic alterations: ALK gene rearrangements, ROS1 rearrangements, BRAF V600E mutations, NTRK gene fusions, MET exon 14 skipping mutations, RET rearrangements, or less common EGFR point mutations of exon 20 S768I, exon 21 L861Q, or exon 18 G719X mutations. The primary hypothesis is that sacituzumab tirumotecan is superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 14, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- Merck Sharp & Dohme LLC
- Interventions being studied
- Biological: Sacituzumab tirumotecan; Drug: Docetaxel; Drug: Pemetrexed
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
The main inclusion and
- include but are not limited to the following: Inclusion Criteria:
- Histologically- or cytologically-documented advanced (Stage III not eligible for resection or curative radiation) or metastatic non-squamous NSCLC with specific mutations.
- Documentation of locally assessed radiological disease progression while on or after last treatment based on Response Evaluation Criteria in Solid Tumors Version (RECIST) 1.1.
- Participants with genome mutations must have received 1 or 2 prior lines of epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), including a third generation TKI for participants with a T790M mutation; and 1 platinum-based therapy after progression on or after EGFR TKI.
- Measurable disease per RECIST 1.1 as assessed by the local site investigator.
- Archival tumor tissue sample or newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated has been provided
- Participants who have AEs due to previous anticancer therapies must have recovered to Grade ≤1 or baseline.
- Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received HBV antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
- Have an ECOG performance status of 0 or 1 within 3 days before randomization.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- UCLA Hematology/Oncology - Santa Monica ( Site 0023)Los Angeles, California
- Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001)Jacksonville, Florida
- Mid Florida Hematology and Oncology Center ( Site 0005)Orange City, Florida
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003)Marietta, Georgia
- Karmanos Cancer Institute ( Site 0018)Detroit, Michigan
- Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027)Rochester, Minnesota
- Hattiesburg Clinic Hematology/Oncology ( Site 0010)Hattiesburg, Mississippi
- University Of Nebraska Medical Center ( Site 0011)Omaha, Nebraska
- Englewood Hospital and Medical Center ( Site 0033)Englewood, New Jersey
- Atlantic Health System Morristown Medical Center ( Site 0031)Morristown, New Jersey
- Capital Health Medical Center - Hopewell ( Site 0006)Pennington, New Jersey
- University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015)Cincinnati, Ohio
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 14, 2026. Always confirm current availability with the study team.