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  • NCT06094296

Not Yet Recruiting

A Study of BMS-986315 and Nivolumab in Combination With Chemotherapy in Participants With First-line Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC) - CA047-1009

Actualizada: 17 octubre, 2023   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 2

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 8

    Ubicación (es)

  • Not Yet Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT
Drug: BMS-986315 Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin Drug: Pemetrexed
Experimental: Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT
Drug: BMS-986315 Drug: Pemetrexed Drug: Paclitaxel Drug: Carboplatin Drug: Cisplatin
Experimental: Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT
Drug: BMS-986315 Drug: Nivolumab Drug: Paclitaxel Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed
Experimental: Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT
Drug: BMS-986315 Drug: Nivolumab Drug: Paclitaxel Drug: Cisplatin Drug: Carboplatin Drug: Pemetrexed
Active Comparator: Part 2: Nivolumab + Histology-based PDCT
Drug: Nivolumab Drug: Pemetrexed Drug: Paclitaxel Drug: Carboplatin Drug: Cisplatin

Criterios clave de elegibilidad

Inclusion Criteria: - Participants must have NSCLC with Stage IV or recurrent disease following multimodal therapy for locally advanced disease. - Study treatment must be first-line therapy for Stage IV or recurrent disease. - Participants in all parts of the study must have: - measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1. (RECIST v1.1) - an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - a life expectancy of at least 3 months at the time of first dose Exclusion Criteria: - Untreated symptomatic central nervous system metastases - Participants with epidermal growth factor receptor (EGFR)/ALK receptor tyrosine kinase (ALK)/ROS proto-oncogene 1 (ROS1)/neurotrophic tyrosine receptor kinase (NTRK)/MET proto-oncogene (MET)/B-Raf proto-oncogene (BRAF)/RET proto-oncogene (RET) mutations amenable to targeted therapies - Participants with any known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug administration or interfere with the interpretation of safety results Note: Other protocol-defined inclusion/exclusion criteria apply.

Recomendamos encarecidamente que se comunique con BMS para informar los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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