Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)
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 pemetrexed in combination with carboplatin for the treatment of epidermal growth factor receptor (EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in this study have NSCLC that has continued to progress on prior treatment with EGFR tyrosine kinase inhibitors (TKIs). The primary hypotheses of this study is that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to overall survival (OS).
Key facts
- Study ID
- NCT06305754
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 551
- Starts
- 2024-06-11
- Expected to finish
- 2030-06-14
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous non-small cell lung cancer (NSCLC).
- Participants who have adverse events (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 Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load.
- Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy.
- Life expectancy of at least 3 months.
You may not qualify if…
- Predominantly squamous cell histology NSCLC.
- History of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
- Grade ≥2 peripheral neuropathy.
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
- Uncontrolled, or significant cardiovascular disease or cerebrovascular disease.
- Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- Received radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study intervention.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Active infection requiring systemic therapy.
- History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- Concurrent active HBV and HCV infection.
- History of allogeneic tissue/solid organ transplant.
- Participants who have not adequately recovered from major surgery or have ongoing surgical complications.
Where it is running
- Kaiser Permanente - Roseville ( Site 0055) — Roseville, California, United States
- Kaiser Permanente - San Francisco ( Site 0056) — San Francisco, California, United States
- Kaiser Permanente - Santa Clara ( Site 0057) — Santa Clara, California, United States
- Kaiser Permanente-Kaiser Permanente ( Site 0036) — Vallejo, California, United States
- Kaiser Permanente - Walnut Creek ( Site 0058) — Walnut Creek, California, 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
- University of Michigan ( Site 0009) — Ann Arbor, Michigan, United States
- Cox Medical Center North - Cox Medical Center/ Hematology/Medical Oncology ( Site 0051) — Springfield, Missouri, United States
- Astera Cancer Care ( Site 0032) — East Brunswick, New Jersey, United States
- Stony Brook University-Cancer Center ( Site 0038) — Stony Brook, New York, United States
- Sanford Fargo Medical Center ( Site 0028) — Fargo, North Dakota, United States
- Sanford Cancer Center ( Site 0024) — Sioux Falls, South Dakota, United States
- John Peter Smith Hospital ( Site 0065) — Fort Worth, Texas, United States
- University of Texas MD Anderson ( Site 0063) — Houston, Texas, United States
- Millennium Research & Clinical Development ( Site 0035) — Houston, Texas, United States
- Clinica Adventista Belgrano-Oncology ( Site 0315) — Caba., Buenos Aires, Argentina
- Instituto Alexander Fleming ( Site 0307) — Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
- Hospital Británico de Buenos Aires-Oncology ( Site 0304) — Buenos Aires, Buenos Aires F.D., Argentina
- Centro Privado de RMI Río Cuarto S.A. II ( Site 0310) — Río Cuarto, Córdoba Province, Argentina
- Instituto de Oncología de Rosario ( Site 0301) — Rosario, Santa Fe Province, Argentina
- Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0303) — La Rioja, Argentina
- Cross Cancer Institute ( Site 0201) — Edmonton, Alberta, Canada
- Waterloo Regional Health Network (WRHN) ( Site 0207) — Kitchener, Ontario, Canada
- Kaiser Permanente - Oakland ( Site 0054) — Oakland, California, United States
Full record on ClinicalTrials.gov
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