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)
Running, not enrolling · Phase 3
Conditions studied: Non-small Cell Lung Cancer (NSCLC)
In brief
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.
Key facts
- Study ID
- NCT06074588
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 556
- Starts
- 2023-11-12
- Expected to finish
- 2030-03-11
- Last updated by the study team
- 2026-07-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Has predominantly squamous cell histology NSCLC.
- Has mixed tumor(s) with small cell elements.
- Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
- Has Grade ≥2 peripheral neuropathy.
- Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
- Has an EGFR T790M mutation and has not received a third generation EGFR TKI (eg, osimertinib).
- Received prior systemic anticancer therapy including investigational agents within 4 weeks or 5 half-lives (whichever is shorter) before randomization.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
- Completed palliative radiotherapy within 7 days of the first dose. Participants must have recovered from all radiation-related toxicities and not require corticosteroids.
- Received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention.
- Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-targeted antibody-drug conjugate (ADC).
- Received prior treatment with a topoisomerase I-containing ADC.
- Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Active infection requiring systemic therapy.
- History of noninfectious pneumonitis/ILD that required steroids or has current pneumonitis/ILD.
- Has known active central nervous system metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable, radiologically stable for at least 4 weeks and do not require glucocorticoids for at least 14 days prior to randomization.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.
Where it is running
- Mayo Clinic in Florida-Mayo Clinic Comprehensive Cancer Center ( Site 0001) — Jacksonville, Florida, United States
- Mid Florida Hematology and Oncology Center ( Site 0005) — Orange City, Florida, United States
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 0003) — Marietta, Georgia, United States
- Karmanos Cancer Institute ( Site 0018) — Detroit, Michigan, United States
- Mayo Clinic in Rochester, Minnesota-Mayo Clinic Comprehensive Cancer Center ( Site 0027) — Rochester, Minnesota, United States
- Hattiesburg Clinic Hematology/Oncology ( Site 0010) — Hattiesburg, Mississippi, United States
- University Of Nebraska Medical Center ( Site 0011) — Omaha, Nebraska, United States
- Englewood Hospital and Medical Center ( Site 0033) — Englewood, New Jersey, United States
- Atlantic Health System Morristown Medical Center ( Site 0031) — Morristown, New Jersey, United States
- Capital Health Medical Center - Hopewell ( Site 0006) — Pennington, New Jersey, United States
- University of Cincinnati Medical Center-University of Cincinnati Cancer Center ( Site 0015) — Cincinnati, Ohio, United States
- Tennessee Oncology (0036) — Nashville, Tennessee, United States
- University of Texas MD Anderson (0037) — Houston, Texas, United States
- VCU Health Adult Outpatient Pavillion ( Site 0026) — Richmond, Virginia, United States
- St. George Private Hospital ( Site 3004) — Kogarah, New South Wales, Australia
- Westmead Hospital ( Site 3000) — Westmead, New South Wales, Australia
- Monash Health-Oncology Research ( Site 3001) — Clayton, Victoria, Australia
- Western Health-Sunshine & Footscray Hospitals-Cancer Services-Cancer Research ( Site 3003) — Melbourne, Victoria, Australia
- Hospital Santa Rita de Cassia (Site 0449) — Vitória, Espírito Santo, Brazil
- Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0447) — Natal, Rio Grande do Norte, Brazil
- Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0440) — Porto Alegre, Rio Grande do Sul, Brazil
- Fundação Pio XII - Hospital de Câncer de Barretos ( Site 0444) — Barretos, São Paulo, Brazil
- ICESP - INSTITUTO DO CÂNCER DO ESTADO DE SÃO PAULO-Pesquisa Clinica (Site 0448) — São Paulo, Brazil
- Hospital Paulistano-Americas Oncologia ( Site 0441) — São Paulo, Brazil
- UCLA Hematology/Oncology - Santa Monica ( Site 0023) — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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