NCT06946797进行中（未招募）2 期
A Phase 2, Open-label, Randomized Trial to Evaluate Two Dosing Regimens of Subcutaneous Formulation of Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent NSCLC
Bristol-Myers Squibb82 个研究点 分布在 11 个国家目标入组 76 人开始时间: 2025年9月19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
- 进行中（未招募）
- 发起方
- 入组人数
- 76
- 试验地点
- 82
- 主要终点
- Maximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serum
研究概览
简要总结
The purpose of this study is to evaluate two dosing regimens of subcutaneous Nivolumab in combination with intravenous Ipilimumab and chemotherapy in participants with previously untreated metastatic 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
- 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 stage IV or recurrent non-small cell lung cancer (NSCLC) (as defined by the 9th edition of the IASLC Lung Cancer Staging Guidelines) of squamous or non-squamous histology.
- •Participants must have no prior systemic anti-cancer treatment (including EGFR, ALK, ROS-1, BRAF, RET, and NTRK inhibitors) given as primary therapy for advanced or metastatic disease.
- •Participants with prior definitive chemoradiation for locally advanced disease is permitted as long as the last administration of chemotherapy or radiotherapy (whichever was given last) occurred at least 6 months prior to randomization. Participants with locally advanced disease with recurrence after chemoradiation therapy (stage III disease, specifically refers to patients with no curative options) are eligible to enroll.
- •Participants with prior adjuvant or neoadjuvant chemotherapy for early-stage lung cancer are permitted if completed at least 6 months prior to randomization.
- •Participants must have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1 at screening and confirmed prior to randomization.
- •Participants must have measurable disease by CT or MRI per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria with radiographic tumor assessment performed within 28 days of randomization.
排除标准
- •Participants must not have any prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- •Participants must not have any known driver mutations with available targeted therapy (including but not limited to EGFR mutations, ALK translocations, ROS-1 translocations and known BRAFV600E, that are sensitive to available targeted inhibitor therapy; participants with a known activating RET mutations and NTRK fusion gene alterations).
- •Participants must not have any untreated central nervous system (CNS) metastases
- •Participants must not have leptomeningeal metastases (carcinomatous meningitis).
- •Participants must not have any active, known or suspected autoimmune disease. Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •Participants with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to randomization and no additional therapy is required or anticipated to be required during the study period.
- •Participants must not have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- •Participants must not have any history of interstitial lung disease or pneumonitis that required oral or IV glucocorticoids to assist with management.
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Arm B
Experimental
干预措施: Cisplatin (Drug)
Arm A
Experimental
干预措施: Nivolumab (Drug)
Arm B
Experimental
干预措施: Paclitaxel (Drug)
Arm B
Experimental
干预措施: Ipilimumab (Drug)
Arm B
Experimental
干预措施: Carboplatin (Drug)
Arm A
Experimental
干预措施: Carboplatin (Drug)
Arm A
Experimental
干预措施: Ipilimumab (Drug)
Arm A
Experimental
干预措施: Pemetrexed (Drug)
Arm B
Experimental
干预措施: Nivolumab (Drug)
Arm A
Experimental
干预措施: Paclitaxel (Drug)
Arm A
Experimental
干预措施: Cisplatin (Drug)
Arm B
Experimental
干预措施: Pemetrexed (Drug)
结局指标
主要结局
Maximum observed serum concentration (Cmax) of subcutaneous Nivolumab in serum
时间窗: Up to 3 weeks
Time to peak concentration (Tmax) of subcutaneous Nivolumab in serum
时间窗: Up to 3 weeks
Area under the concentration-time curve within a dosing interval (AUC(TAU)) of subcutaneous Nivolumab in serum
时间窗: Up to 3 weeks
Concentration at the end of a dosing interval (Ctau) of subcutaneous Nivolumab in serum
时间窗: Up to 3 weeks
Trough observed concentration (Ctrough) of subcutaneous Nivolumab
时间窗: At Cycle 7 Day 1 (Week 18)
次要结局
- Number of deaths(Up to approximately 2.5 years)
- Number of participants with anti-ipilimumab antibodies(Up to approximately 2.5 years)
- Cmax of intravenous Ipilimumab in serum(Up to 6 weeks)
- Number of participants with adverse events (AEs)(Up to approximately 2.5 years)
- Number of participants with serious adverse events (SAEs)(Up to approximately 2.5 years)
- Number of participants with drug related AEs(Up to approximately 2.5 years)
- Number of participants with Immune Mediated Adverse Events (IMAEs)(Up to approximately 2.5 years)
- Number of participants with AEs leading to discontinuation(Up to approximately 2.5 years)
- Number of participants with anti-nivolumab antibodies(Up to approximately 2.5 years)
- Number of participants with neutralizing antibodies(Up to approximately 2.5 years)
- Tmax of intravenous Ipilimumab in serum(Up to 6 weeks)
- AUC(TAU) of intravenous Ipilimumab in serum(Up to 6 weeks)
- Ctau of intravenous Ipilimumab in serum(Up to 6 weeks)
研究者
研究点 (82)
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