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RECRUITING Phase 3

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)

NCT06074588 · View on ClinicalTrials.gov ↗

Study Summary

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 hypotheses are that sacituzumab tirumotecan is: (1) superior to chemotherapy with respect to progression-free survival (PFS) per RECIST 1.1 as assessed by BICR in NSCLC with EGFR mutations; and (2) superior to chemotherapy with respect to overall survival (OS) in NSCLC with EGFR mutations.

Interventions

  • BIOLOGICAL Sacituzumab tirumotecan
  • DRUG Docetaxel
  • DRUG Pemetrexed

Study Locations (20)

New Jersey

  • Englewood Hospital and Medical Center ( Site 0033) — Englewood
  • Atlantic Health System Morristown Medical Center ( Site 0031) — Morristown
  • Capital Health Medical Center - Hopewell ( Site 0006) — Pennington

Florida

  • Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001) — Jacksonville
  • Mid Florida Hematology and Oncology Center ( Site 0005) — Orange City

New South Wales

  • St. George Private Hospital ( Site 3004) — Kogarah
  • Westmead Hospital ( Site 3000) — Westmead

Victoria

  • Monash Health-Oncology Research ( Site 3001) — Clayton
  • Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003) — Melbourne

California

  • UCLA Hematology/Oncology - Santa Monica ( Site 0023) — Los Angeles

Georgia

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003) — Marietta

Michigan

  • Karmanos Cancer Institute ( Site 0018) — Detroit

Minnesota

  • Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027) — Rochester

Trial Details

FieldValue
Enrollment Target 556 participants
Start Date 2023-11-12
Est. Completion 2030-03-11
Phase Phase 3

Sponsor

Merck Sharp & Dohme

741 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06074588

The ClinicalTrials.gov registry entry for NCT06074588 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 556 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Merck Sharp & Dohme, which has 741 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 3 interventions — of which Sacituzumab tirumotecan is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06074588 reports 20 study locations spanning 15 distinct geographic areas — top geographies include New Jersey, Florida, New South Wales. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06074588 about?

NCT06074588 is a clinical study titled "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 o...

What is the current status of trial NCT06074588?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 556 participants. The study started on 2023-11-12. Estimated completion is 2030-03-11.

What conditions does trial NCT06074588 study?

This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06074588?

The interventions under investigation include: Sacituzumab tirumotecan (BIOLOGICAL), Docetaxel (DRUG), Pemetrexed (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06074588?

This trial is sponsored by Merck Sharp & Dohme, which has 741 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06074588 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial