EUCTR2014-003090-42-GB进行中（未招募）1 期
REACTION: A phase II study of etoposide and cis/carboplatin with or without pembrolizumab in untreated extensive small cell lung cancer - REACTIO
European Organisation for Research and Treatment of Cancer (EORTC)0 个研究点目标入组 118 人开始时间: 2018年4月20日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 118
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
入选标准
- •Step 1 - Eligibility check.
- •-Histologically or cytologically confirmed SCLC diagnosis;
- •-Extended disease according to the criteria of the Veteran's Administration Lung Cancer Group (VALG): disease extended beyond a hemithorax and the supraclavicular node area. Pleural involvement will be considered as extended disease;
- •-At least 18 years;
- •-Before patient registration, written informed consent must be given according to ICH/GCP, and national/local regulations;
- •-Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2 (Patients who are judged by the investigator to be PS 2 due to the primary disease are the only PS 2 patients who are eligible);
- •Step 2 - Randomization check.
- •-Tumor assessment performed within 10 days before patient randomization. Patient may or may not have measurable disease;
- •-Previous palliative brain radiotherapy is allowed if terminated at least 3 weeks before patient randomization;
- •-Partial or complete response according to RECIST 1.1 after 2 cycles of any platinum and etoposide-based induction chemotherapy regimen;
- •-Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1;
- •-At least three months life expectancy;
- •-Adequate hematopoietic, hepatic and renal function assessed within 10 days before patient randomization and defined in the protocol;
- •-Women of child bearing potential (WOCBP) must have a negative urine or serum pregnancy test within 72 hours before patient randomization;
- •-Patients of childbearing / reproductive potential should use adequate birth control measures, as defined by the investigator, during the study treatment period and for at least 120 days after the last dose of pembrolizumab and for at least 180 days after the last dose of chemotherapy drugs. A highly effective method of birth control is defined as those which result in low failure rate (i.e. less than 1% per year) when used consistently and correctly;
- •-Male patients with pregnant or non-pregnant WOCBP partner should use condom or sexual abstinence (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient) during the study treatment period and for at least 120 days after the last dose of pembrolizumab and for at least 180 days after the last dose of chemotherapy drugs;
- •-Female subjects who are breast feeding should discontinue nursing before randomization and until 120 days after the last study treatment;
- •-Absence of any clinical, psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- •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 92
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 26
排除标准
- •Step 2 - Randomisation check.
- •-Prior systemic therapy for SCLC; previous treatment with platinum and etoposide concomitant with RT for LD is allowed if terminated at least 1 year before patient randomization;
- •-Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are stable (i.e. without evidence of progression by imaging and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and have not received steroids for at least 7 days before patient randomization;
- •-History of interstitial lung disease (ILD) OR a history of (non-infectious) pneumonitis that required oral or IV steroids (other than COPD exacerbation) or current pneumonitis or current evidence of interstitial lung disease;
- •-Active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Any replacement therapy (i.e., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment and is allowed. Patients with hyperthyroidism or hypothyroidism but that are stable on hormone replacement are also allowed;
- •-Previous allogeneic tissue/solid organ transplant;
- •-Active infection requiring therapy;
- •-Known history of Human Immunodeficiency Virus (HIV) (known HIV 1/2 antibodies positive). No known active Hepatitis B or C. Active Hepatitis B is defined as a known positive HBsAg results. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay;
- •-Ongoing grade = 2 peripheral neuropathy;
- •-Prior treatment with anti-PD-1, anti-PD-L1/2, anti- CD137, CTLA-4 modulators;
- •-Chronic use of immunosuppressive agents and/or systemic corticosteroids or any use in the last 3 days before patient randomization;
- •-Prior use of live vaccines within 30 days before patient randomization;
- •-Concurrent treatment with any investigational agent within 4 weeks before patient randomization.
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