Resumen

El propósito de este estudio es evaluar la eficacia de añadir lazertinib a amivantamab, carboplatino y pemetrexed (estrategias de dosificación LACP/ACP-L) y amivantamab, carboplatino y pemetrexed (ACP) en comparación con carboplatino y pemetrexed (CP) en participantes con cáncer de pulmón de células no pequeñas (CPNM) no escamoso, localmente avanzado o metastásico, con deleción en el exón 19 o sustitución L858R en el exón 21 del receptor del factor de crecimiento epidérmico (EGFR), tras el fracaso de osimertinib. El propósito de la cohorte de extensión es describir con mayor detalle la seguridad y eficacia del esquema de dosificación ACP-L frente a ACP con datos adicionales. Tras la finalización del análisis primario, el estudio podrá eventualmente pasar a una fase de extensión abierta (OLE) o extensión a largo plazo (LTE), durante la cual los participantes tendrán la opción de continuar el tratamiento asignado.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participant must have at least 1 measurable lesion, according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, that has not been previously irradiated
Participant must have histologically or cytologically confirmed, locally advanced or metastatic, non-squamous non-small cell lung cancer (NSCLC), characterized at or after the time of locally advanced or metastatic disease diagnosis by either epidermal growth factor receptor (EGFR) Exon 19del or Exon 21 L858R mutation
A participant with a history of brain metastases must have had all lesions treated as clinically indicated (that is, no current indication for further definitive local therapy). Any definitive local therapy to brain metastases must have been completed at least 14 days prior to randomization and the participant can be receiving no greater than10 milligrams (mg) prednisone or equivalent daily for the treatment of intracranial disease
Participant must have Eastern Cooperative Oncology Group (ECOG) status of 0 or 1
Any toxicities from prior systemic anticancer therapy must have resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 Grade 1 or baseline level (except for alopecia \[any grade\], Grade \<= 2 peripheral neuropathy, or Grade \<= 2 hypothyroidism stable on hormone replacement)
A participant of childbearing potential must have a negative serum pregnancy test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study
Participant must have progressed on or after osimertinib monotherapy as the most recent line of treatment. Osimertinib must have been administered as either the first-line treatment for locally advanced or metastatic disease or in the second- line setting after prior treatment with first- or second-generation EGFR tyrosine kinase inhibitor (TKI) as a monotherapy. Participants who received either neoadjuvant and/or adjuvant treatment of any type are eligible if progression to locally advanced or metastatic disease occurred at least 12 months after the last dose of such therapy and then the participant progressed on or after osimertinib in the locally advanced or metastatic setting. Treatment with osimertinib must be discontinued at least 8 days (4 half-lives) prior to randomization (that is last dose no later than Day -8)

Criterios de exclusión

Participant received radiotherapy for palliative treatment of NSCLC less than 14 days prior to randomization
Participant with symptomatic or progressive brain metastases
Participant has history of or current evidence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation
Participant has known small cell transformation
Participant has a medical history of interstitial lung disease (ILD), including drug-induced ILD or radiation pneumonitis
Participant has a history of clinically significant cardiovascular disease including, but not limited to diagnosis of deep vein thrombosis or pulmonary embolism within 4 weeks prior to randomization; myocardial infarction; unstable angina; stroke; transient ischemic attack; coronary/peripheral artery bypass graft; or acute coronary syndrome. Participant has a significant genetic predisposition to venous thromboembolic events. Participant has a prior history of venous thromboembolic events and is not on appropriate therapeutic anticoagulation as per National Comprehensive Cancer Network or local guidelines

Ubicaciones

CINME Centro de Investigaciones Metabolicas

Caba, Argentina

IADT Instituto Argentino de Diagnostico y Tratamiento

CABA, Argentina

Centro Medico Fleischer

CABA, Argentina

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

CABA, Argentina

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Córdoba, Argentina

Hospital Privado Universitario De Cordoba

Córdoba, Argentina

Hospital Privado de la Comunidad

Mar del Plata, Argentina

Clínica Viedma

Viedma, Argentina

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Lazertinib

Amivantamab

Pemetrexed

Carboplatin

Ubicaciones

CINME Centro de Investigaciones Metabolicas

IADT Instituto Argentino de Diagnostico y Tratamiento

Centro Medico Fleischer

CEMIC (Centro de Educación Médica e Investigaciones Clínicas)

Cemaic Centro Privado de Especialidades Medicas Ambulatorias e Investigacion Clinica

Hospital Privado Universitario De Cordoba

Hospital Privado de la Comunidad

Clínica Viedma

Patrocinadores