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临床试验/NCT07680764
NCT07680764招募中2 期

A Phase 2, Randomized, Open-label, Study Assessing the Safety, Tolerability and Efficacy of Imzokitug in Combination With Pumitamig and Platinum-Doublet Chemotherapy (PDCT) Versus Pumitamig and PDCT as First-line Treatment for Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

Bristol-Myers Squibb73 个研究点 分布在 9 个国家目标入组 160 人开始时间: 2026年8月31日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
160
试验地点
73
主要终点
Objective response rate (ORR) by investigator (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to assess the safety, tolerability, and efficacy of Imzokitug in combination with Pumitamig and Platinum-Doublet Chemotherapy (PDCT) versus Pumitamig and PDCT as first-line treatment for participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Participants must have histologically confirmed diagnosis of stage IV non-small cell lung cancer (NSCLC) (squamous or non-squamous) or recurrent unresectable disease per the American joint committee on cancer (AJCC) Staging System 9th edition.
  • •Participants must have no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.
  • •Tumor tissue (fresh or archival) obtained within 5 months of enrollment (signing of informed consent) for each participant must be submitted by the site.
  • •Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or
  • •Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

排除标准

  • •Participants must not have any documented actionable genomic alterations (AGAs) for which first line approved targeted therapies are indicated.
  • •Participants must not have prior treatment with immuno-oncology therapies.
  • •Participants must not have untreated central nervous system (CNS) metastases.
  • •Other protocol-defined Inclusion/Exclusion criteria apply.

研究组 & 干预措施

Arm A: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Pumitamig (Drug)

Arm B: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Pumitamig (Drug)

Arm C: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Pumitamig (Drug)

Arm D: Pumitamig + Histology-based PDCT

Experimental

干预措施: Pumitamig (Drug)

Arm D: Pumitamig + Histology-based PDCT

Experimental

干预措施: Vedolizumab (Drug)

Arm D: Pumitamig + Histology-based PDCT

Experimental

干预措施: Pemetrexed (Drug)

Arm D: Pumitamig + Histology-based PDCT

Experimental

干预措施: Cisplatin (Drug)

Arm D: Pumitamig + Histology-based PDCT

Experimental

干预措施: Paclitaxel (Drug)

Arm D: Pumitamig + Histology-based PDCT

Experimental

干预措施: Infliximab (Drug)

Arm A: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Imzokitug (Drug)

Arm B: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Imzokitug (Drug)

Arm B: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Vedolizumab (Drug)

Arm C: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Infliximab (Drug)

Arm A: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Pemetrexed (Drug)

Arm B: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Carboplatin (Drug)

Arm B: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Pemetrexed (Drug)

Arm C: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Paclitaxel (Drug)

Arm B: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Cisplatin (Drug)

Arm B: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Infliximab (Drug)

Arm C: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Imzokitug (Drug)

Arm A: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Carboplatin (Drug)

Arm B: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Paclitaxel (Drug)

Arm A: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Paclitaxel (Drug)

Arm A: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Vedolizumab (Drug)

Arm C: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Pemetrexed (Drug)

Arm A: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Infliximab (Drug)

Arm C: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Carboplatin (Drug)

Arm A: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Cisplatin (Drug)

Arm C: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Cisplatin (Drug)

Arm C: Pumitamig + Imzokitug + Histology-based PDCT

Experimental

干预措施: Vedolizumab (Drug)

Arm D: Pumitamig + Histology-based PDCT

Experimental

干预措施: Carboplatin (Drug)

结局指标

主要结局

Objective response rate (ORR) by investigator (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1)

时间窗: Up to approximately 4 years

次要结局

  • Overall survival (OS)(Up to approximately 4 years)
  • Duration of response (DOR) by investigator (per RECIST v1.1)(Up to approximately 4 years)
  • Number of participants with adverse events (AEs)(Up to 90 days after discontinuation of study treatment)
  • Number of participants with serious adverse events (SAEs)(Up to 90 days after discontinuation of study treatment)
  • Number of participants with treatment-related AEs(Up to 90 days after discontinuation of study treatment)
  • Number of participants with treatment-related SAEs(Up to 90 days after discontinuation of study treatment)
  • Number of participants with AEs leading to discontinuation(Up to 90 days after discontinuation of study treatment)
  • Number of deaths(Up to 90 days after discontinuation of study treatment)
  • Progression free survival (PFS) by investigator (per RECIST v1.1)(Up to approximately 4 years)
  • Time to recurrence (TTR) by investigator (per RECIST v1.1)(Up to approximately 4 years)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (73)

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