Resumen

El objetivo de este estudio es evaluar sacituzumab tirumotecan frente a pemetrexed en combinación con carboplatino para el tratamiento del cáncer de pulmón no microcítico (CPNM) no escamoso avanzado con mutación del receptor del factor de crecimiento epidérmico (EGFR). Los participantes de este estudio presentan CPNM que ha continuado progresando tras el tratamiento previo con inhibidores de tirosina quinasa (ITK) de EGFR. Las hipótesis primarias de este estudio son que sacituzumab tirumotecan es superior a la quimioterapia doble basada en platino (pemetrexed y carboplatino) en cuanto a supervivencia libre de progresión (SLP) y supervivencia global (SG).

Descripción detallada

Los participantes serán aleatorizados 1:1 en dos brazos: * Sacituzumab tirumotecan * Pemetrexed más carboplatino Los participantes recibirán tratamiento hasta que se cumpla alguno de los criterios de discontinuación de la intervención del estudio.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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.

Criterios de exclusión

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.

Intervenciones

biological

Sacituzumab tirumotecan

4 mg/kg via IV infusion

drug

Pemetrexed

500 mg/m\^2 via IV infusion

drug