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临床试验/NCT06094296
NCT06094296终止2 期

A Randomized, Double-blind, Phase 2 Study of BMS-986315 and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

Bristol-Myers Squibb8 个研究点 分布在 2 个国家目标入组 1 人开始时间: 2023年11月27日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
发起方
入组人数
1
试验地点
8
主要终点
Number of Participants With Adverse Events (AEs) for Part 1

研究概览

简要总结

The purpose of this study is to evaluate the efficacy and safety of BMS-986315 plus nivolumab in combination with platinum-based doublet chemotherapy (PDCT) versus nivolumab in combination with PDCT in the first-line treatment of Stage IV or recurrent 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • 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.
  • (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

排除标准

  • 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.

研究组 & 干预措施

Part 2: Nivolumab + Histology-based PDCT

Active Comparator

干预措施: Paclitaxel (Drug)

Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Experimental

干预措施: BMS-986315 (Drug)

Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT

Experimental

干预措施: BMS-986315 (Drug)

Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Pemetrexed (Drug)

Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Cisplatin (Drug)

Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Carboplatin (Drug)

Part 1: BMS-986315 Dose Level (DL) 1 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Paclitaxel (Drug)

Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Experimental

干预措施: BMS-986315 (Drug)

Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Pemetrexed (Drug)

Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Cisplatin (Drug)

Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Carboplatin (Drug)

Part 1: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Paclitaxel (Drug)

Part 2: Nivolumab + Histology-based PDCT

Active Comparator

干预措施: Nivolumab (Drug)

Part 2: Nivolumab + Histology-based PDCT

Active Comparator

干预措施: Pemetrexed (Drug)

Part 2: Nivolumab + Histology-based PDCT

Active Comparator

干预措施: Cisplatin (Drug)

Part 2: Nivolumab + Histology-based PDCT

Active Comparator

干预措施: Carboplatin (Drug)

Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Nivolumab (Drug)

Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Pemetrexed (Drug)

Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Cisplatin (Drug)

Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Carboplatin (Drug)

Part 2: BMS-986315 DL 2 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Paclitaxel (Drug)

Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT

Experimental

干预措施: BMS-986315 (Drug)

Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Nivolumab (Drug)

Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Pemetrexed (Drug)

Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Cisplatin (Drug)

Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Carboplatin (Drug)

Part 2: BMS-986315 DL 1 + Nivolumab + Histology-based PDCT

Experimental

干预措施: Paclitaxel (Drug)

结局指标

主要结局

Number of Participants With Adverse Events (AEs) for Part 1

时间窗: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.

Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 1

时间窗: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.

Number of Participants With Serious Adverse Events (SAEs) for Part 1

时间窗: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 1

时间窗: From first dose (Cycle 1 Day 1) up to day 28

Dose-Limiting Toxicities (DLTs) are treatment effects serious enough to prevent dose increase. Severity grades: 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death * Grade 2 uveitis or eye pain not improving or require systemic treatment * Grade 2 pneumonitis or interstitial lung disease \>14 days * Grade ≥ 3 uveitis, episcleritis, iritis, pneumonitis, bronchospasm or neurologic toxicity * Grade 3 colitis not responding \>48 hours * Hepatic abnormalities without liver metastases: serum transaminases (AST/ALT) \>5x \& ≤ 8xULN for \>2weeks, AST/ALT \>8xULN regardless of duration, total bilirubin \>3xULN, or concurrent AST/ALT \>3xULN \& total bilirubin \>2xULN * Hepatic abnormalities with liver metastases: AST/ALT \>8x \& ≤10xULN for \>2 weeks, AST/ALT \>10xULN regardless of duration, total bilirubin \> 3xULN, or concurrent AST/ALT \>8xULN \& total bilirubin \>2xULN * Grade 3 (hypersensitivity reaction not resolving to Grade 1 in 6 hours; fatigue \>7 days; nausea, vomiting, or diarrhea \>72 hours)

Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 1

时间窗: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition occurring in a clinical investigation participant after signing of informed consent, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory test result), symptom, or disease temporally associated with the study intervention.

Number of Participants Who Died in Part 1

时间窗: From first dose through 100 days following last dose of study treatment (assessed for approximately 7 months)

Number of participants who died during the study

Objective Response Rate (ORR) for Part 2

时间窗: From randomization until the date of first objectively documented progression or start of subsequent therapy whichever occurred first (planned for up to approximately 5 years)

Objective response rate (ORR) is defined as the number of participants who achieve a best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR), based on blinded independent central review (BICR) assessments using Response Evaluation Criteria in Solid Tumors (RECIST 1.1), divided by the number of all randomized participants. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. No participants were enrolled in Part 2 due to the study termination; therefore, no data were collected for this endpoint.

次要结局

  • Progression Free Survival (PFS) for Part 2(From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years))
  • Disease Control Rate (DCR) for Part 2(From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years))
  • Maximum Observed Serum Concentration (Cmax) for Part 2(Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (Each Cycle is of 21 Days))
  • Time of Maximum Observed Concentration (Tmax) for Part 2(C1D1, C1D2, C1D4, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C5D2, C5D4, C5D8, C5D15, Day 1 of every 4 cycles from cycle 6 (up to 2 years); at 30 and 100 days post last dose (Each Cycle is of 21 Days))
  • Number of Participants With Adverse Events (AEs) for Part 2(Up to 100 days after discontinuation of study treatment)
  • Number of Participants With Treatment Related Adverse Events (TRAEs) for Part 2(Up to 100 days after discontinuation of study treatment)
  • Number of Participants With Serious Adverse Events (SAEs) for Part 2(Up to 100 days after discontinuation of study treatment)
  • Number of Participants With Adverse Events (AEs) Meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria for Part 2(Up to 100 days after discontinuation of study treatment)
  • Number of Participants With Adverse Events (AEs) Leading to Discontinuation for Part 2(Up to 100 days after discontinuation of study treatment)
  • Number of Participants Who Died in Part 2(Up to 100 days after discontinuation of study treatment)
  • Area Under the Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for Part 2(C1D1, C1D2, C1D4, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C5D2, C5D4, C5D8, C5D15, Day 1 of every 4 cycles from cycle 6 (up to 2 years); at 30 and 100 days post last dose (Each Cycle is of 21 Days))
  • Number of Participants With Anti-drug Antibodies (ADA) to BMS-986315 for Part 2(Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Day 1 of every 4 cycles from cycle 6 (up to 2 years); at 30 and 100 days post last dose (Each Cycle is of 21 Days))
  • Duration of Response (DoR) for Part 2(From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years))
  • Time to Objective Response (TTR) for Part 2(From randomization until the date of first objectively documented progression or death due to any cause, whichever occurred first (planned for up to approximately 5 years))

研究者

发起方
Bristol-Myers Squibb
申办方类型
Industry
责任方
Sponsor

研究点 (8)

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