Estudio aleatorizado de fase 2/3 de BMS-986504 en combinación con pembrolizumab y quimioterapia frente a placebo más pembrolizumab y quimioterapia en participantes con cáncer de pulmón de células no pequeñas metastásico en primera línea con deleción homocigota de MTAP

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07063745Tipo: INTERVENTIONALInicio: 2 de ene de 2026Fin estimado: 12 de ago de 2031

Resumen

El propósito de este estudio es comparar el beneficio clínico de la combinación de BMS-986504 (un inhibidor selectivo cooperativo con MTA de PRMT5) más pembrolizumab y quimioterapia frente a placebo más pembrolizumab y quimioterapia en participantes con cáncer de pulmón de células no pequeñas metastásico en primera línea con deleción homocigota de MTAP.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must have Metastatic (Stage IV or recurrent) non-small cell lung cancer (NSCLC) (as defined by the American Joint Committee on Cancer, Ninth Edition) with no prior systemic anti-cancer therapy for metastatic disease.
Participants must have histologically confirmed diagnosis of NSCLC and homozygous methylthioadenosine phosphorylase (MTAP) deletion or MTAP loss.
Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Participants must have at least 1 measurable lesion as per RECIST v1.1.

Criterios de exclusión

Nonsquamous participants must not have documented targetable oncogenic mutation or actionable genetic alterations (AGAs) for which there is a standard of care (SoC) available as first-line (1L) therapy.
Participants must not have symptomatic brain metastases or spinal cord compression.
Participants must not have any prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for metastatic non-small cell lung cancer (mNSCLC).
Note: One cycle of SoC treatment prior to randomization will be allowed for participants who require immediate treatment if clinically indicated.
Participants must not have any known or suspected impairment of gastrointestinal function that may prohibit the ability to absorb or swallow an oral medication without chewing or crushing.