Resumen

El propósito del estudio es simplificar la administración intravenosa de amivantamab y reducir los tiempos de dosificación, evaluando una nueva formulación de amivantamab, amivantamab subcutáneo coformulado con hialuronidasa humana recombinante (SC-CF), para administración subcutánea. Esta formulación tiene el potencial de mejorar la experiencia tanto del paciente como del médico con amivantamab al proporcionar una administración más sencilla y acelerada.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Have histologically or cytologically confirmed, advanced or metastatic non-small cell lung cancer (NSCLC), characterized by either epidermal growth factor receptor (EGFR) Exon 19 deletion (Exon 19del) or Exon 21 leucine 858 to arginine substitution (Exon 21 L858R) mutation by an Food and Drug Administration (FDA)-approved or other validated test of either circulating tumor deoxyribonucleic acid (ctDNA) or tumor tissue in a clinical laboratory improvement amendments (CLIA) certified laboratory (sites in the United Started \[US\]) or an accredited local laboratory (sites outside of the US)
Have progressed on or after osimertinib (or another approved 3rd generation epidermal growth factor receptor \[EGFR\] tyrosine kinase inhibitor \[TKI\]) and platinum-based chemotherapy (irrespective of order). a) The 3rd generation EGFR TKI must have been administered as the first EGFR TKI for metastatic disease or as the second TKI after prior treatment with first- or second-generation EGFR TKI in participants with metastatic EGFR T790M mutation positive NSCLC. b) Participants who decline or are otherwise ineligible for chemotherapy may be enrolled after discussion with the medical monitor. c) Any adjuvant or neoadjuvant treatment, whether with a 3rd generation EGFR TKI or platinum based chemotherapy, would count towards the prior treatment requirement if the participant experienced disease
Have at least 1 measurable lesion, according to response evaluation criteria in solid tumors (RECIST) version 1.1
Have an eastern cooperative oncology group (ECOG) performance status of 0 to 1
Any toxicities from prior anticancer therapy must have resolved to common terminology criteria for adverse events (CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade less than or equal to (\<=) 2 peripheral neuropathy, and Grade \<=2 hypothyroidism stable on hormone replacement)

Criterios de exclusión

Participant has received cytotoxic, investigational, or targeted therapies beyond one regimen of platinum-based chemotherapy and EGFR inhibitors
Participant has received radiotherapy for palliative purposes less than 7 days prior to randomization
Participant has symptomatic or progressive brain metastases
Participant has leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
Participant has uncontrolled tumor-related pain
Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis

Intervenciones

drug

Lazertinib

Lazertinib tablets will be administered orally.

drug

Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)

Amivantamab injection will be administered subcutaneously by manual injection.

drug

Amivantamab Intravenous

Amivantamab will be administered by IV infusion.

Ubicaciones

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

Buenos Aires, Argentina

Centro Oncológico Korben

Buenos Aires, Argentina

IADT Instituto Argentino de Diagnostico y Tratamiento

CABA, Argentina

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina

Sanatorio Allende

Córdoba, Argentina

Clínica Viedma

Viedma, Argentina

Estudio de fase 3, abierto y aleatorizado de lazertinib con amivantamab subcutáneo comparado con amivantamab intravenoso en pacientes con cáncer de pulmón de células no pequeñas avanzado o metastásico con mutación de EGFR tras progresión con osimertinib y quimioterapia

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Lazertinib

Amivantamab Subcutaneous and Co-Formulated with Recombinant Human Hyaluronidase (SC CF)

Amivantamab Intravenous

Ubicaciones

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

Centro Oncológico Korben

IADT Instituto Argentino de Diagnostico y Tratamiento

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Sanatorio Allende

Clínica Viedma

Patrocinadores