EUCTR2013-003760-30-BE进行中（未招募）不适用
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)
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 1,002
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1) Written informed consent, before any trial-related activities are carried out.
- •2) 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.
- •3) Prior concurrent CRT which is defined as follows:
- •- Minimum of 2 cycles of platinum-based chemotherapy.
- •- Radiotherapy with total tumor dose = 60 Gray (Gy) and a single fraction dose = 1.8 Gy.
- •- 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).
- •4) 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
- •5) An Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- •6) A platelet count, white blood cells (WBC) and hemoglobin value as defined in the protocol.
- •7) Male or female,
- •8) 18 years of age or over.
- •Other protocol defined inclusion criteria could apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 637
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 365
排除标准
- •1) Undergone lung cancer specific therapy (including surgery) other than initial concurrent CRT.
- •2) Received chemotherapy during radiotherapy in radiosensitizing doses only.
- •3) Metastatic disease.
- •4) Malignant pleural effusion at initial diagnosis, during initial CRT, and/or at trial entry.
- •5) Past or current history of neoplasm other than lung carcinoma, except for curatively treated nonmelanoma skin cancer, in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years.
- •6) 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.
- •7) Splenectomy.
- •8) Any preexisting medical condition requiring chronic systemic steroid or immunosuppressive therapy (steroids for the treatment of radiation pneumonitis are allowed).
- •9) Receipt of immunotherapy (as defined in the protocol) within 4 weeks prior to randomization.
- •10) Receipt of investigational systemic drugs (including off-label use of approved products) within 4 weeks (28 days) prior to randomization.
- •11) Autoimmune disease.
- •12) Active or chronic infectious hepatitis.
- •13) Infectious process that, in the opinion of the investigator, could compromise the subject’s ability to mount an immune response.
- •14) Clinically significant hepatic dysfunction, renal dysfunction and cardiac disease as defined in the protocol.
- •15) Clinically significant hepatic dysfunction, renal dysfunction and cardiac disease as defined in the protocol.
- •16) Clinically significant cardiac disease, e.g., New York Heart Association (NYHA) classes III-IV; uncontrolled angina, uncontrolled arrhythmia or
- •uncontrolled hypertension, myocardial infarction in the previous 6 months as confirmed by an ECG.
- •17) Pregnant or breast-feeding women (for details see
- •Inclusion Criteria).
- •18) Known drug abuse/alcohol abuse.
- •19) Participation in another interventional clinical trial within the past 28 days (excluding purely observational studies).
- •20) Requires concurrent treatment with a non-permitted drug.
- •21) Known hypersensitivity to any of the trial treatment ingredients.
- •22) Legal incapacity or limited legal capacity.
- •23) Any other reason that, in the opinion of the investigator, precludes the subject from participating in the trial
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