NCT02906150Unknown2 期
Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) Chemotherapy Plus Cisplatin (or Carboplatin) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type
SciClone Pharmaceuticals8 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2016年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 140
- 试验地点
- 8
- 主要终点
- Time to progression free survival (PFS)
研究概览
简要总结
Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type
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
- •Age 18 years or older
- •Histological or cytological confirmation of NSCLC (may be from initial diagnosis of NSCLC or subsequent biopsy). Only patients with available tissue samples may be included in the study (see major details in section 8 for the minimum sample characteristics)
- •Activating mutations of EGFR diagnosis of Stage IIIB (with cytologically proven pleural effusion or pericardial effusion) or metastatic NSCLC, not amenable to curative surgery or radiotherapy
- •Measurable disease by Response Evaluation Criteria in Solid Tumours (RECIST) in a lesion not previously irradiated or non-measurable disease (non measurable disease only for Phase I)
- •Eastern Cooperative Oncology Group - performance status (ECOG-PS) 0-2
- •Absolute neutrophil count (ANC) > 1.5 x 109/liter (L) and platelets > 100 x 109/L
- •Bilirubin level either normal or <1.5 x ULN
- •AST (SGOT) and ALT (SGPT) <2.5 x ULN (≤ 5 x ULN if liver metastases are present)
- •Serum creatinine <1.5 x ULN
- •Effective contraception for both, male and female patients, if the risk of conception exists
- •Provision of written informed consent to the analysis of biological markers (registration)
排除标准
- •Prior therapy with Thymosin alpha-1
- •Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation
- •Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies
- •Radiotherapy within 14 days prior to drug administration, except as follows:
- •Palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and
- •Single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling
- •Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (SD) (no steroid therapy or steroid dose being tapered) for at least 28 days
- •Patients with toxicities that have not come back (at least) to grade 1
- •Pregnancy or suspected pregnancy
- •Known severe hypersensitivity to TKI products
- •Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Any evidence of clinically active interstitial lung disease (ILD) (patients with chronic, stable, radiographic changes who are asymptomatic or patients with uncomplicated progressive lymphangitic carcinomatosis need not be excluded)
- •As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- •As judged by the investigator, any inflammatory changes of the surface of the eye
- •Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
研究组 & 干预措施
Thymalfasin (Thymosin alpha 1, Ta1)
Experimental
Arm A: 70 patients will receive Thymosin alpha 1 in 1mL SC injection five times a week (first four months); then two times a week for eight months. SoC chemotherapy and cisplatin (or carboplatin) for twelve months.
干预措施: Thymalfasin (Thymosin alpha 1, Ta1) (Drug)
Thymalfasin (Thymosin alpha 1, Ta1)
Experimental
Arm A: 70 patients will receive Thymosin alpha 1 in 1mL SC injection five times a week (first four months); then two times a week for eight months. SoC chemotherapy and cisplatin (or carboplatin) for twelve months.
干预措施: SoC (chemotherapy and platinum agent) (Drug)
SoC (chemotherapy and platinum agent)
Active Comparator
Arm B: 70 patients (control group) will receive SoC chemotherapy and cisplatin (or carboplatin) for twelve months.
干预措施: SoC (chemotherapy and platinum agent) (Drug)
结局指标
主要结局
Time to progression free survival (PFS)
时间窗: Up to 12 months
次要结局
未报告次要终点
研究者
研究点 (8)
Loading locations...
相似试验
进行中（未招募）
1 期
Thymosin alpha 1 plus maintenance therapy with the Standard of Care (SoC) chemotherapy plus cisplatin (or carboplatin) in patients with metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild type.metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR wild typeMedDRA version: 20.0 Level: LLT Classification code 10064049 Term: Lung adenocarcinoma metastatic System Organ Class: 100000004864EUCTR2015-005605-36-ITSCICLONE PHARMACEUTICALS ITALY S.R.L.140
Unknown
2 期
A Phase II Trial of S-1 as Maintenance Treatment After Gemcitabine Plus Cisplatin Regimen Chemotherapy in Patients With Recurrent and/or Metastatic Nasopharyngeal Carcinoma.Nasopharyngeal CarcinomaNCT02878889Zhejiang Cancer Hospital53
已完成
2 期
Maintenance Therapy for Small-cell Lung CancerProgression Free SurvivalNCT03769935Qingdao Central Hospital90
尚未招募
2 期
Maintenance Chemotherapy With S-1, Locally Advanced Esophageal Cancer Receiving Definitive CCRTLocally Advanced Unresectable Esophageal CancerNCT06598917China Medical University Hospital60
已完成
1 期
Combination chemotherapy of TS-1, oxaliplatin and irinotecan (TIROX) for unresectable gastric cancer; a phase I studygastric cancerJPRN-UMIN000030482Osaka Medical College Hospital18