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NCT06074588 · ClinicalTrials.gov registry record · 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)
A Phase 3 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 556
- Enrollment target
- 20
- Study locations
NCT06074588 is a Phase 3 study of Non-small Cell Lung Cancer (NSCLC) that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 556 participants, above the 279-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (99% higher). The trial reports 20 study locations across 15 states.
The verdict
NCT06074588, a Phase 3 study of Non-small Cell Lung Cancer (NSCLC), is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 556 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 556 participants |
| Start Date | 2023-11-12 |
| Est. Completion | 2030-03-11 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 556 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 279-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (99% higher). The listed sponsor is Merck Sharp & Dohme, which has 558 total studies on file at ClinicalTrials.gov.
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.
NCT06074588 reports 20 study locations spanning 15 distinct geographic areas - top geographies include New Jersey, Florida, New South Wales.
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).
What interventions are being tested in trial NCT06074588?
The interventions under investigation include: Sacituzumab tirumotecan (BIOLOGICAL), Docetaxel (DRUG), Pemetrexed (DRUG).
Who is sponsoring clinical trial NCT06074588?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
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.
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