A Study of Nivolumab +/- Docetaxel in Patients Previously Treated With Advanced or Metastatic NSCLC
A Study of Nivolumab +/- Docetaxel in Patients Previously Treated With Advanced or Metastatic Non Small Cell Lung Cancer
This study is a randomized, single-center, open-label, phase II clinical trial designed to evaluate non-small cell lung cancer that has failed to undergo excessive platinum-based chemotherapy and has not received excessive statin chemotherapy and has not received immunotherapy. The efficacy and safety of Nivolumab in combination with docetaxel and Nivolumab in patients.
Qualified patients were stratified by histological type (squamous cell carcinoma vs. non-squamous cell carcinoma) randomized to receive the following regimen in a 1:1 ratio:
Group A: Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Group B: Nivolumab 200mg IV q2w All patients were evaluated for tumor at baseline, and tumor evaluations were performed every 6 weeks within 48 weeks after randomization (regardless of whether dosing was delayed). After the 48th week of assessment, a tumor assessment is required every 9 weeks until disease progression, withdrawal of informed consent, sponsor termination study, or patient death.
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Beijing
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Beijing、Beijing、中国、100142
- 招聘中
- Beijing Cancer Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Men & women ≥18, and ≤75 years of age.
- Subjects with histologically or cytologically-documented non-squamous cell NSCLC who present with Stage IIIB/IV disease or recurrent or progressive disease following multimodal therapy (radiation therapy, surgical resection, or definitive chemoradiation therapy for locally advanced disease) and who will receive study therapy as second line of treatment for advanced disease.
- The patient's tumor must be free of EGFR gene-sensitive mutations (including but not limited to exon 19 deletion mutation or exon 21 L858R mutation, exon 21 L861Q, exon 18 G719X or exon 20 S768I site Mutation) and ALK gene rearrangement. If the pathology is squamous cell carcinoma or the tumor of a known patient has a KRAS mutation, then EGFR and ALK are not required to be detected.
- Disease recurrence or progression during/after one prior platinum doublet-based chemotherapy regimen for advanced or metastatic disease.
- Measurable disease by Computed tomography (CT)/Magnetic resonance imaging (MRI) per RECIST 1.1 criteria.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Expected survival time ≥ 12 weeks.
Has adequate organ and bone marrow function, defined as follows:
- Hemoglobin ≥ 9.0 g/dL.
- Absolute neutrophil count ≥1.5 × 109 /L.
- Platelet count ≥80 × 109 /L.
- Serum total bilirubin ≤ 1.5 × normal upper limit (ULN); for patients with liver metastasis, serum total bilirubin ≤ 5 × normal upper limit (ULN).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; for patients with liver metastases: ALT and AST ≤ 5 × ULN.
- Serum creatinine (Cr) ≤ 1.5 times the upper limit of normal (ULN).
- Pre-menopausal women have a negative urine or serum pregnancy test within 14 days prior to initiation of treatment.
- Written informed consent was signed prior to the experiment.
Exclusion Criteria:
- Have been treated with docetaxel or have previously received immunological checkpoint inhibitors targeting PD-1, PD-L1 or CTLA-4.
- Prior to randomization ≤ 21 days (or ≤ 5 half-lives, whichever is shorter) have received chemotherapy, other test drugs, and Chinese herbal medicines used to control cancer.
- Uncontrolled brain metastases and all meningeal metastases. Stereotactic radiotherapy within 7 days prior to the start of treatment in the first cycle, or brain metastases who underwent whole brain radiotherapy within the first 14 days (if the patient detected a new asymptomatic CNS metastasis during the screening scan, then radiotherapy must be received) And/or central nervous system metastases. After treatment, these patients do not require additional brain scans to enter the trial if other inclusion criteria are met.
- Large area radiotherapy (except for local palliative radiotherapy for bones).
- Pericardial effusion, pleural effusion, or ascites that is clinically uncontrolled and requires pericardial puncture, thoracic puncture, or abdominal puncture drainage within 2 weeks of randomization.
- A history of malignancy other than NSCLC within the first 5 years of randomization, except for malignant tumors with a very low risk of metastatic death and expected to heal after treatment (eg fully treated cervical carcinoma in situ, basal or squamous cell skin cancer, accepted Localized prostate cancer for radical treatment, ductal carcinoma in situ for radical surgery).
- Have undergone major surgery (as defined by the investigator) within 28 days prior to the first dose. Note: For the purpose of palliative care, local surgical treatment of isolated lesions is acceptable.
- Any condition that, depending on the investigator's judgment, interferes with the evaluation of the efficacy of the study drug or explains the patient's safety or findings, including but not limited to: persistent or active infection, symptomatic congestive heart failure, poorly controlled hypertension, Unstable angina, arrhythmia, or psychiatric/social conditions that affect the study's requirements, significantly increase the risk of AEs in the study drug, or affect the patient's ability to provide informed consent.
- Active or previously documented autoimmune or inflammatory disease (with vitiligo, hypothyroidism (after Hashimoto's syndrome) and stable disease after hormone replacement therapy, no active disease in the past 5 years Patients can be enrolled).
- Active infections, including tuberculosis, hepatitis B, and hepatitis C.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Nivolumab + Docetaxel
Nivolumab was administered at a dose of 300 mg on the first day of the 21-day cycle (every 3 weeks; q3w) when combined with docetaxel, and administered at a dose of 200 mg on the first day of each 14-day cycle (every 2 weeks; q2w) after stopping docetaxel treatment. On the first day of each cycle (21 days), docetaxel 75 mg/m2 was infused by IV on Day 1 of each 21-day cycle for 4-6 cycles (judged by investigator). |
Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Nivolumab 200mg IV q2w
其他名称:
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有源比较器:Nivolumab
Nivolumab was administered in the monotherapy group at a dose of 200 mg on the first day of each 14-day cycle (every 2 weeks; q2w).
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Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Nivolumab 200mg IV q2w
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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无进展生存期
大体时间:24个月
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无进展生存期
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24个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
操作系统
大体时间:24个月
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总生存期
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24个月
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Nivolumab的临床试验
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Jason J. Luke, MDArray BioPharma主动,不招人
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Parker Institute for Cancer ImmunotherapyBristol-Myers Squibb; Cancer Research Institute, New York City完全的
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Gustave Roussy, Cancer Campus, Grand Paris招聘中复发/难治性 ALK+ 间变性大细胞淋巴瘤法国, 丹麦, 荷兰
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Famewave Ltd.Bristol-Myers Squibb主动,不招人
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The Clatterbridge Cancer Centre NHS Foundation...Bristol-Myers Squibb; University of Liverpool主动,不招人
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HUYABIO International, LLC.Bristol-Myers Squibb招聘中不可切除或转移性黑色素瘤 | 进行性脑转移西班牙, 美国, 意大利, 日本, 比利时, 法国, 新西兰, 巴西, 大韩民国, 澳大利亚, 德国, 新加坡, 捷克语, 奥地利, 南非, 英国, 波多黎各