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A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors
Overall Recruitment Status: Active, currently enrolling
 
Official Title
A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors
 
Region Sponsors
California - Northern
Merck Sharp & Dohme LLC
 
Acronym NCT No.
NCT06305754
 
Study Type Phase
INTERVENTIONAL
Phase III
 
Purpose
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 are that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to progression-free survival (PFS) and overall survival (OS).
 
Detailed Description
 
 
 
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 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 is 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.
 
Keywords and/or Specific Medical Conditions
  • Non-Small-Cell Lung,
  • Bronchogenic,
  • Pulmonary Disease
  • Carcinoma,
  • Respiratory Tract Diseases,
  • Carcinoma,
  • Respiratory Tract Neoplasms,
  • Lung Diseases,
  • Thoracic Neoplasms,
  • Neoplasms by Site,
  • Bronchial Neoplasms
  • Neoplasms,
  • Lung Neoplasms,
 
KP Clinical Facility
  • Diablo Medical Center-Walnut Creek
  • Oakland Medical Center
  • Roseville Medical Center
  • Santa Clara Medical Center-Homestead
  • South San Francisco Medical Center
  • Vallejo Medical Center
 
Clinical Area
  • Pulmonary Disease


Principal Investigator:
Jennifer Suga
Contact Information:
- CTP Collaborate Team
-CTPCollaborate@kp.org
-All Kaiser Permanente Northern California Medical Centers


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