Resumen

Este ensayo clínico está diseñado para evaluar la eficacia y la seguridad de trastuzumab deruxtecán (T-DXd; Enhertu®) en combinación con pembrolizumab frente a quimioterapia basada en platino en combinación con pembrolizumab en participantes sin tratamiento previo para CPNCP no escamoso localmente avanzado irresecable o metastásico, cuyos tumores presentan sobreexpresión de HER2 y TPS de PD-L1 < 50%, sin alteraciones genómicas accionables (AGA) conocidas que dispongan de terapias localmente disponibles dirigidas a dichas AGA en el contexto de primera línea avanzado/metastásico.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Sign and date the Tissue Screening ICF, prior to any Tissue Screening procedure. Sign and date the Main ICF, prior to the start of any trial-specific qualification procedures.
Sign and date the Optional PGx ICF (included in the Main Screening ICF) prior to any PGx procedure, and the Pregnant Partner ICF, if applicable.
Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old.
Histologically documented non-squamous locally advanced unresectable or metastatic
NSCLC and meets all of the following criteria:
Has Stage IV NSCLC disease or Stage IIIB or IIIC disease but is not a candidate for surgical resection or definitive chemoradiation at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Has no known AGAs (based on existing test result of local test) that have locally available therapies targeting their AGAs in the first-line advanced/metastatic setting. Has no known HER2 mutation based on existing test results (if approved or validated local test is available). Note: Participants with mixed histology are eligible if adenocarcinoma is the predominant histology. Mixed tumors will be classified based on the predominant cell type.
Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC. Participants who received adjuvant or neoadjuvant therapy other than those listed below, including ICI (ie, anti-PD-1/PD-L1) or a platinum-based regimen, are eligible if the last dose of adjuvant/neoadjuvant therapy was given at least 6 months before the date of the first trial dose and should not have progressed on or within 6 months of the last dose date of adjuvant/neoadjuvant therapy.
Any agent, including an ADC, containing a chemotherapeutic agent targeting topoisomerase I.
HER2-targeted antibody-based anticancer therapy.
Has adequate tumor tissue sample (not previously irradiated) available for assessment of HER2 and PD-L1 expression by central or Sponsor-specified laboratory. A new biopsy is required if the participant's most recent archival tumor tissue sample cannot be supplied.
Details pertaining to tumor tissue submission can be found in the Trial Laboratory Manual.

Criterios de exclusión

Has a medical history of MI within 6 months before randomization/enrollment or symptomatic CHF (NYHA Class II to Class IV). Participants with troponin levels above the ULN at Screening (as defined by the manufacturer) and without any MI-related symptoms should have a cardiologic consultation during the Screening Period to rule out MI.
Has a QTc prolongation to \>480 ms based on the average of the Screening triplicate 12- lead ECG.
Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
Has lung-specific, intercurrent, clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (eg, pulmonary emboli within 3 months of the trial randomization, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.).
Had a prior complete pneumonectomy.

Intervenciones

drug

Trastuzumab Deruxtecan

T-DXd will be administered at a dose of 5.4 mg/kg intravenously (IV) every 3 weeks (Q3W)

drug

pembrolizumab

pembrolizumab will be administered at a dose of 200 mg IV Q3W

drug

Pemetrexed

Pemetrexed will be administered at a dose of 500 mg/m2 IV Q3W

drug

Chemotherapy

One of the following two will be administered in Arm B: Cisplatin at a dose of 75 mg/m2 IV or carboplatin AUC at a dose of 5 mg/mL/min IV

Ubicaciones

CINME - Centro De Investigaciones Metabolicas

Buenos Aires, Argentina

RECRUITING

Instituto Argentino de Diagnostico y Tratamiento

Buenos Aires, Argentina

RECRUITING

Instituto de Investigaciones Metabolicas (IDIM)

Buenos Aires, Argentina

RECRUITING

Instituto Medico de la Fundacion Estudios Clinicos

Rosario, Argentina

RECRUITING

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Trastuzumab Deruxtecan

pembrolizumab

Pemetrexed

Chemotherapy

Ubicaciones

CINME - Centro De Investigaciones Metabolicas

Instituto Argentino de Diagnostico y Tratamiento

Instituto de Investigaciones Metabolicas (IDIM)

Instituto Medico de la Fundacion Estudios Clinicos

Patrocinadores

Contactos

Contact for Trial Information