NCT02049151终止3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial of Tecemotide Versus Placebo in Subjects With Completed Concurrent Chemo-radiotherapy for Unresectable Stage III Non-small Cell Lung Cancer (NSCLC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- EMD Serono
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Overall Survival
研究概览
简要总结
This is a multi-center, double-blind, placebo-controlled, randomized, Phase 3 trial in subjects with unresectable stage III non-small cell lung cancer (NSCLC) who have demonstrated either stable disease or objective response following primary concurrent chemo-radiotherapy (CRT), comparing overall survival (OS) time in subjects treated with tecemotide versus subjects treated with tecemotide-matching placebo.
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
- 否
入选标准
- •Written informed consent, before any trial-related activities are carried out
- •Histologically or cytologically documented unresectable stage III NSCLC, including bronchioalveolar carcinomas. Cancer stage must be confirmed and documented by computed tomography (CT), magnetic resonance imaging (MRI) or positron emission tomography (PET) scan
- •Prior concurrent CRT which is defined as follows:
- •Minimum of 2 cycles of platinum-based chemotherapy
- •Radiotherapy with a total tumor dose greater than equal to (>=) 60 Gray and a single fraction dose >= 1.8 Gray
- •Overlap of radiotherapy with minimum 2 cycles of platinum-based chemotherapy (one cycle is defined as either 3 or 4 weeks depending on the chemotherapy regimen). A deviation of 2 to 3 days from an exact overlap is acceptable. Purely radiosensitizing doses of chemotherapy are not acceptable (for example [e.g.], daily low dose regimens; weekly carbo-platinum + paclitaxel regimens are allowed).
- •Subjects must have completed the primary thoracic CRT at least 4 weeks (28 days) and no later than 12 weeks (84 days) prior to randomization. Subjects who received prophylactic brain irradiation as part of primary CRT are eligible.
- •Documented stable disease or objective response, according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, after primary concurrent CRT for unresectable stage III disease, within 4 weeks (28 days) prior to randomization
- •An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •A platelet count, white blood cells (WBC) and hemoglobin value as defined in the protocol
- •Male or female, greater than or equal to 18 years of age
- •Other protocol defined inclusion criteria could apply
排除标准
- •Undergone lung cancer specific therapy (including surgery) other than initial concurrent CRT
- •Received chemotherapy during radiotherapy in radiosensitizing doses only (e.g., daily low dose regimens; weekly carbo-platinum + paclitaxel regimens are allowed).
- •Metastatic disease
- •Malignant pleural effusion at initial diagnosis, during initial CRT, and/or at trial entry
- •Past or current history of neoplasm other than lung carcinoma, except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years
- •A recognized immunodeficiency disease including human immunodeficiency virus (HIV) infection and other cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, congenital or acquired immunodeficiencies
- •Splenectomy
- •Any preexisting medical condition requiring chronic systemic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed)
- •Receipt of immunotherapy (as defined in the protocol) within 4 weeks prior to randomization
- •Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks prior to randomization
- •Autoimmune disease
- •Active or chronic infectious hepatitis
- •Infectious process that, in the opinion of the Investigator, could compromise the subject's ability to mount an immune response
- •Clinically significant hepatic dysfunction, renal dysfunction and cardiac disease as defined in the protocol
- •Pregnant or breast-feeding women
- •Known drug abuse/alcohol abuse
- •Participation in another interventional clinical trial within the past 28 days (excluding purely observational studies)
- •Requires concurrent treatment with a non-permitted drug
- •Known hypersensitivity to any of the trial treatment ingredients
- •Legal incapacity or limited legal capacity
- •Any other reason that, in the opinion of the Investigator, precludes the subject from participating in the trial
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
Tecemotide
Experimental
干预措施: Tecemotide (Drug)
Tecemotide
Experimental
干预措施: Cyclophosphamide (CPA) (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Placebo
Placebo Comparator
干预措施: Saline (sodium chloride) (Drug)
结局指标
主要结局
Overall Survival
时间窗: Time from date of randomization until death, assessed maximum up to 16 months
Overall survival (OS) was defined as the time (in months) from randomization to death. Data has been presented in terms of number subjects who died and number of censored subjects.
次要结局
- Time to Progression (TTP)(Time from date of randomization until PD, assessed up to 16 months)
- Time to Symptom Progression (TTSP)(Time from date of randomization until progressive disease (PD), assessed up to 16 months)
- Progression Free Survival (PFS)(Time from date of randomization until PD or death, assessed up to 16 months)
- Number Subjects With Treatment Emergent Adverse Events (TEAEs), Serious TEAEs, National Cancer Institute-Common Toxicity Criteria (NCI-CTC)Grade 3/4 TEAEs, TEAEs Leading to Permanent Discontinuation, TEAEs Leading to Death, Injection Site Reactions (ISRs)(Time from first dose up to 42 days after the last dose of the trial treatment: assessed maximum up to 16 months)
研究者
研究点 (2)
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