NCT03353675已完成2 期
A Phase II Study Evaluating the Efficacy and the Safety of First-line Chemotherapy Combined With TG4010 and Nivolumab in Patients With Advanced Non-squamous Non-Small Cell Lung Cancer (NSCLC)
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Transgene
- 入组人数
- 44
- 试验地点
- 9
- 主要终点
- Objective Response Rate (ORR)
研究概览
简要总结
This is a multicenter, single arm, open label phase II study in treatment-naïve for advanced stage of the disease and immunotherapy-naïve patients with advanced non-squamous NSCLC and with < 50% of tumor cells expressing programmed death-ligand 1 (PD-L1) by immunohistochemical (IHC) staining.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Female or male patients age > 18 years-old
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 at study entry
- •Life expectancy of at least 3 months
- •Histologically confirmed non-squamous NSCLC (adenocarcinoma, large cell carcinoma, undifferentiated carcinoma or other)
- •Stage IIIB-IV cancer or delayed relapse of any stage not amenable to surgery or radiotherapy with curative intent.
- •PD-L1 expression by immunohistochemistry in < 50% of tumor cells
- •Patients must be chemotherapy-naïve for the advanced stage of the disease. Previous neoadjuvant and/or adjuvant chemotherapy is allowed for patients who successfully underwent complete radical surgery and if last treatment was administered more than 12 months prior to the start of the study treatment.
- •At least one measurable lesion by CT scan based on RECIST 1.1 performed within 28 days prior to start of study treatment
- •Adequate hematological, hepatic, and renal functions
- •Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 72 hours prior to the start of study drug
- •WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug plus 30 days for a total of 5 months posttreatment completion. Highly effective contraception are defined in the protocol.
- •Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug (s) plus 5 half-lives of study drug (s) plus 90 days for a total of 7 months post-treatment completion
排除标准
- •Patients having central nervous system (CNS) metastases
- •Patients with pericardial effusion
- •Prior exposure to cancer immunotherapy including cancer vaccines, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-Lymphocyte antigen- 4 antibody or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways
- •Patients with epidermal growth factor receptor (EGFR) activating mutations or anaplastic lymphoma kinase (ALK)- rearrangements leading to eligibility for tyrosine kinase inhibitor (TKI) treatment (tests mandatory)
- •Prior history of other malignancy except basal cell carcinoma of the skin, cervical intra epithelial neoplasia, and other cancer curatively treated with no evidence of disease for at least 3 years
- •Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
- •Patients with an active, known or suspected autoimmune disease
- •Patient with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity
- •Patients with grade ≥ 2 neuropathy
- •Signs or symptoms of infection within 14 days prior to start of study treatment or active infection requiring systemic therapy
- •Positive serology for HIV or hepatitis C virus (HCV); presence in the serum of the antigens hepatitis B (HBs) at baseline
- •Patient with any underlying medical condition that the treating physician considers might be aggravated by treatment or which is not controlled (e.g., elevated troponin or creatinine, uncontrolled diabetes)
- •History of cardiovascular conditions within 12 months of enrollment
- •Left ventricular ejection fraction less than the Lower Limit of Normal as assessed by echocardiography (or multigated acquisition (MUGA) scan)
- •Patient with major surgery or radiotherapy within 3 weeks prior to the start of the study treatment. However, prior surgery or radiation therapy aimed at local palliation or attempted local disease control (except in case of thoracic radiotherapy) is permitted but has to be completed 2 weeks before treatment start
- •Pregnant or nursing (lactating) women
- •Patients with an organ allograft
- •Any known allergy to eggs, gentamicin or history of allergy or hypersensitivity to study drug components
- •Participation in a clinical study with an investigational product within 4 weeks prior to the start of the study treatments
研究组 & 干预措施
TG4010/Chemotherapy/Nivolumab
Experimental
干预措施: TG4010 (Biological)
TG4010/Chemotherapy/Nivolumab
Experimental
干预措施: Chemotherapy (Drug)
TG4010/Chemotherapy/Nivolumab
Experimental
干预措施: Nivolumab (Drug)
结局指标
主要结局
Objective Response Rate (ORR)
时间窗: 15 months
Percentage of participants whose best overall response is complete response or partial response using RECIST 1.1. confirmed by a second scan no less than 4 weeks after the criteria for response are first met. Complete response: disappearance of all lesions and no new lesions. Partial response: decrease of at least 30% in the sum of the diameters of measurable lesions taking as reference the baseline sum of diameters, no progression of non-measurable lesions and no new lesions.
次要结局
- Number of Participants With Adverse Events or Abnormalities(28 months)
- Progression Free Survival (PFS)(28 months)
- Disease Control Rate (DCR)(15 months)
- Overall Survival(28 months)
- Duration of Overall Response (DoR)(28 months)
研究者
研究点 (9)
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