Un estudio de fase III, aleatorizado, doble ciego, multic... | EligiMed

Un estudio de fase III, aleatorizado, doble ciego, multicéntrico, global de rilvegostomig o pembrolizumab en combinación con quimioterapia basada en platino para el tratamiento de primera línea de pacientes con cáncer de pulmón de células no pequeñas no escamoso metastásico cuyos tumores expresan PD-L1 (ARTEMIDE-Lung03)

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06627647Tipo: INTERVENTIONALInicio: 27 de nov de 2024Fin estimado: 25 de mar de 2030

Oncología Neumología Alergia e Inmunología

Resumen

El objetivo de ARTEMIDE-Lung03 es evaluar la eficacia y seguridad de rilvegostomig en comparación con pembrolizumab, ambos en combinación con quimioterapia dobleta basada en platino, como tratamiento de primera línea en pacientes con mNSCLC no escamoso cuyos tumores expresan PD-L1.

Descripción detallada

Se trata de un estudio de fase III, de dos brazos, aleatorizado, doble ciego, global, multicéntrico, que evalúa la eficacia y seguridad de rilvegostomig en comparación con pembrolizumab, ambos en combinación con quimioterapia dobleta basada en platino, como tratamiento de primera línea (1L) en pacientes con mNSCLC no escamoso cuyos tumores expresan PD-L1 (TC ≥ 1%).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically or cytologically documented non-squamous NSCLC.
Stage IV mNSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L therapies.
Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%.
At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT or MRI and is suitable for accurate repeated measurements.
Adequate organ and bone marrow function

Criterios de exclusión

Presence of small cell and neuroendocrine histology components.
Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
Any prior systemic therapy received for advanced or mNSCLC. Prior systemic therapy in the neoadjuvant or adjuvant setting and/or definitive radio- or chemoradiotherapy for early-stage disease are allowed, provided that recurrence or progression has occurred \> 12 months after the end of treatment.
Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
Active primary immunodeficiency/active infectious disease(s).
Active tuberculosis infection.

Intervenciones

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