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Pesquisa Study Connect

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

Atualizado: 20 maio, 2024   |   ClinicalTrials.gov

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Detalhes do estudo

  • Phase 2

    Fase

  • Gênero(s)

  • 18+

    Faixa etária

  • 15

    Localização(ões)

  • Recruiting

Opções de tratamento

Braços de tratamento do Estudo
INTERVENÇÃO ATRIBUÍDA
Experimental: Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT
Drug: BMS-986315, Pemetrexed, Paclitaxel, Carboplatin, Cisplatin
Experimental: Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT
Drug: BMS-986315, Pemetrexed, Paclitaxel, Carboplatin, Cisplatin
Experimental: Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT
Drug: BMS-986315, Nivolumab, Paclitaxel, Cisplatin, Carboplatin, Pemetrexed
Experimental: Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT
Drug: BMS-986315, Nivolumab, Paclitaxel, Cisplatin, Carboplatin, Pemetrexed
Active Comparator: Part 2: Nivolumab + Histology-based PDCT
Drug: Nivolumab, Pemetrexed, Paclitaxel, Carboplatin, Cisplatin

Principais critérios de elegibilidade

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.

É altamente recomendável que você entre em contato com a BMS para relatar efeitos colaterais (eventos adversos).
Efeitos colaterais (eventos adversos) e outros eventos relatáveis estão definidos aqui.
Relate efeitos colaterais (eventos adversos) ou reclamações sobre a qualidade do produto: Informações médicas

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