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Clinical Trials in Poland / NCT06305754
Active, not recruiting Phase 3

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)

NCT06305754 · tracked via the Priya Life Science Poland tracker
Phase
Phase 3
Started
2024-06-11
Last updated
2026-09-11

Condition(s) studied

Non-small Cell Lung Cancer (NSCLC)

Investigational drug(s) / intervention(s)

Sacituzumab tirumotecan →Pemetrexed →Carboplatin →H1 Receptor AntagonistH2 Receptor AntagonistAcetaminophen (or equivalent) →Dexamethasone (or equivalent) →Steroid Mouthwash (dexamethasone or equivalent) →

Sacituzumab tirumotecan: 4 mg/kg via IV infusion

Pemetrexed: 500 mg/m\^2 via IV infusion

Carboplatin: AUC 5 mg/mL\*min via IV infusion

H1 Receptor Antagonist: Administered as rescue medication per approved product label

H2 Receptor Antagonist: Administered as rescue medication per approved product label

Acetaminophen (or equivalent): Administered as rescue medication per approved product label

Dexamethasone (or equivalent): Administered as rescue medication per approved product label

Steroid Mouthwash (dexamethasone or equivalent): Administered as rescue medication per approved product label

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Trial sites (156)

FacilityCityRegionStatus
Kaiser Permanente - Oakland ( Site 0054) Oakland California
Kaiser Permanente - Roseville ( Site 0055) Roseville California
Kaiser Permanente - San Francisco ( Site 0056) San Francisco California
Kaiser Permanente - Santa Clara ( Site 0057) Santa Clara California
Kaiser Permanente-Kaiser Permanente ( Site 0036) Vallejo California
Kaiser Permanente - Walnut Creek ( Site 0058) Walnut Creek California
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
University of Michigan ( Site 0009) Ann Arbor Michigan
Cox Medical Center North - Cox Medical Center/ Hematology/Medical Oncology ( Site 0051) Springfield Missouri
Astera Cancer Care ( Site 0032) East Brunswick New Jersey
Stony Brook University-Cancer Center ( Site 0038) Stony Brook New York
Sanford Fargo Medical Center ( Site 0028) Fargo North Dakota
Sanford Cancer Center ( Site 0024) Sioux Falls South Dakota
John Peter Smith Hospital ( Site 0065) Fort Worth Texas
University of Texas MD Anderson ( Site 0063) Houston Texas
Millennium Research & Clinical Development ( Site 0035) Houston Texas
Clinica Adventista Belgrano-Oncology ( Site 0315) Caba. Buenos Aires
Instituto Alexander Fleming ( Site 0307) Ciudad Autónoma de Buenos Aires Buenos Aires
Hospital Británico de Buenos Aires-Oncology ( Site 0304) Buenos Aires Buenos Aires F.D.
Centro Privado de RMI Río Cuarto S.A. II ( Site 0310) Río Cuarto Córdoba Province
Instituto de Oncología de Rosario ( Site 0301) Rosario Santa Fe Province
Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0303) La Rioja Argentina
Cross Cancer Institute ( Site 0201) Edmonton Alberta
Waterloo Regional Health Network (WRHN) ( Site 0207) Kitchener Ontario
Princess Margaret Cancer Centre ( Site 0203) Toronto Ontario
McGill University Health Centre ( Site 0204) Montreal Quebec
Anhui Provincial Cancer Hospital ( Site 3132) Hefei Anhui
Beijing Cancer hospital ( Site 3100) Beijing Beijing Municipality
Beijing Peking Union Medical College Hospital-pneumology department ( Site 3107) Beijing Beijing Municipality
Chongqing University Cancer Hospital-Medical Oncology ( Site 3128) Chongqing Chongqing Municipality
Fujian Cancer Hospital ( Site 3124) Fuzhou Fujian
The First Affiliated hospital of Xiamen University ( Site 3125) Xiamen Fujian
Southern Medical University Nanfang Hospital-Depatrment of Respiratory and Critical Care Medicine ( Site 3102) Guangzhou Guangdong
Guangxi Medical University Affiliated Tumor Hospital-Respiratory Oncology ( Site 3103) Nanning Guangxi
Harbin Medical University Cancer Hospital ( Site 3109) Harbin Heilongjiang
Henan Cancer Hospital ( Site 3105) Zhengzhou Henan
Tongji Hospital Tongji Medical,Science & Technology ( Site 3121) Wuhan Hubei
Hubei Cancer Hospital ( Site 3122) Wuhan Hubei
The Second Xiangya Hospital of Central South University-Oncology ( Site 3104) Changsha Hunan

+ 116 more sites — see the full list on the official registry below.

More Merck Sharp & Dohme LLC trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06305754 on ClinicalTrials.gov ↗ ← All trials in Poland