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)

Launched by MERCK SHARP & DOHME LLC · Mar 5, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called sacituzumab tirumotecan to see how it compares to a standard combination of two existing drugs, pemetrexed and carboplatin, for patients with advanced non-small cell lung cancer (NSCLC) that has changed or worsened after previous treatments. The goal is to find out if sacituzumab tirumotecan can help patients live longer without their cancer getting worse compared to the standard treatment.

To participate in this trial, you need to have been diagnosed with advanced nonsquamous NSCLC and have had prior treatment with EGFR tyrosine kinase inhibitors, which are a type of targeted therapy. You also need to be in generally good health, with a life expectancy of at least three months. Participants will receive either the new treatment or the standard combination, and the study will monitor how well each option works. It's important to know that this trial is currently recruiting participants and is open to people of all genders, typically aged 65 to 74. If you think you might be eligible or have questions, discussing this with your healthcare provider can help you understand more about your options.

Gender

ALL

Eligibility criteria

• 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 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.