NCT02566993已完成3 期
Phase III Randomized Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin Versus Cyclophosphamide, Doxorubicin and Vincristine (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (ATLANTIS)
PharmaMar160 个研究点 分布在 5 个国家目标入组 613 人开始时间: 2016年8月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 613
- 试验地点
- 160
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Phase III randomized clinical trial of lurbinectedin (PM01183)/doxorubicin (DOX) versus cyclophosphamide (CTX), doxorubicin (DOX) and vincristine (VCR) (CAV) or topotecan as treatment in patients with small-cell lung cancer (SCLC) who failed one prior platinum-containing line.
详细描述
Multicenter, open-label, randomized, controlled phase III clinical trial to evaluate and compare the activity and safety of an experimental arm consisting of PM01183/DOX combination followed by PM01183 alone, if applicable vs. best Investigator's choice between CAV or topotecan as a control arm, in SCLC patients who failed one prior platinum-containing line but no more than one prior chemotherapy-containing line.
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
- •Voluntary written informed consent
- •Adult patients ≥ 18 years
- •Histologically or cytologically confirmed diagnosis of limited or extensive stage SCLC which failed one prior platinum-containing regimen and with a chemotherapy-free interval (CTFI, time from the last dose of first-line chemotherapy to the occurrence of progressive disease) ≥ 30 days. Small-cell carcinoma of unknown primary site with or without neuroendocrine features confirmed in histology test(s) performed on metastatic lesion(s) are eligible, if Ki-67/MIB-1 is expressed in >50% of tumor cells.
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤
- •Adequate hematological, renal, metabolic and hepatic function within 7-10 days prior to randomization
- •At least three weeks since last prior anticancer treatment and adequate recovery from prior treatment toxicity
- •Prior radiotherapy (RT): At least four weeks since completion of whole-brain irradiation, at least two weeks since completion of prophylactic cranial irradiation, and to any other site.
- •Evidence of non-childbearing status for women of childbearing potential (WOCBP). WOCBP must agree to use a highly effective contraceptive measure up to six weeks after treatment discontinuation. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product dose.
排除标准
- •More than one prior chemotherapy-containing line(re-challenge with the same initial regimen is not allowed)
- •Patients who never received platinum-containing regimen for Small-cell Lung Cancer (SCLC)
- •Prior treatment with PM01183, topotecan or anthracyclines.
- •Limited-stage patients who are candidates for local or regional therapy
- •Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization.
- •Symptomatic or progressing or steroid requiring Central Nervous System (CNS) involvement disease at least four weeks prior to randomization
- •Concomitant diseases/conditions:
- •Angina, myocardial infarction, congestive heart failure or clinically significant valvular heart disease, arrhythmia, immunodeficiency (including known HIV seropositive), ongoing or treatment-requiring chronic liver disease, active infection, oxygen requirement within two weeks prior to randomization, diffuse interstitial lung disease (ILD) or pulmonary fibrosis, second invasive malignancy treated with chemotherapy and/or radiotherapy, invasive fungal infections requiring systemic treatment within 12 weeks of randomization.
- •Pregnant or breast feeding women
研究组 & 干预措施
Experimental Arm
Experimental
Lurbinectedin (PM01183) / Doxorubicin
干预措施: Lurbinectedin (PM01183) (Drug)
Experimental Arm
Experimental
Lurbinectedin (PM01183) / Doxorubicin
干预措施: Doxorubicin (DOX) (Drug)
Control Arm 1
Active Comparator
CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR))
干预措施: Doxorubicin (DOX) (Drug)
Control Arm 1
Active Comparator
CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR))
干预措施: Cyclophosphamide (CTX) (Drug)
Control Arm 1
Active Comparator
CAV (Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR))
干预措施: Vincristine (VCR) (Drug)
Control Arm 2
Active Comparator
Topotecan
干预措施: Topotecan (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Every three months up to death or study termination, a period of approximately 3.5 years
Overall survival (OS) will be calculated from the date of randomization to the date of death (death event) or last contact(in this case, survival will be censored on that date).
次要结局
- Overall Response Rate in Patients Without Central Nervous System Involvement at Baseline(Every three months up to death or study termination, a period of approximately 3.5 years)
- Best Antitumor Response in Patients With Chemotherapy-free Interval <90 Days(Every three months up to death or study termination, a period of approximately 3.5 years)
- Difference in Overall Survival Between Lurbinectedin/Doxorubicin (DOX) and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 12 Months(At 12 months)
- Progression-free Survival (PFS) by Independent Review Committee(Every six weeks up to progression disease, a period of approximately 3.5 years)
- Progression-free Survival Rate at 6 Months by Independent Review Committee(At 6 months)
- Progression-free Survival Rate at 12 Months by Independent Review Committee(at 12 months)
- Best Antitumor Response by Independent Review Committee(Every three months up to death or study termination, a period of approximately 3.5 years)
- Duration of Response by Independent Review Committee(Every three months up to death or study termination, a period of approximately 3.5 years)
- Overall Response Rate in Patients With Chemotherapy-free Interval ≥ 90 Days(Every three months up to death or study termination, a period of approximately 3.5 years)
- Progression-free Survival in Patients With Chemotherapy-free Interval <90 Days(Every six weeks up to progression disease, a period of approximately 3.5 years)
- Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 18 Months(At 18 months)
- Difference in Overall Survival Between Lurbinectedin/DOX and CAV in Patients With CAV as Best Investigator's Choice: Overall Survival Rate at 24 Months(At 24 months)
- Overall Response Rate by Independent Review Committee(Every three months up to death or study termination, a period of approximately 3.5 years)
- Overall Survival in Patients With Chemotherapy-free Interval ≥ 90 Days(Every three months up to death or study termination, a period of approximately 3.5 years)
- Duration of Response in Patients With Chemotherapy-free Interval ≥ 90 Days(Every three months up to death or study termination, a period of approximately 3.5 years)
- Overall Survival in Patients Without Central Nervous System Involvement at Baseline(Every three months up to death or study termination, a period of approximately 3.5 years)
- Overall Survival in Patients With Central Nervous System Involvement at Baseline(Every three months up to death or study termination, a period of approximately 3.5 years)
- Best Antitumor Response in Patients With Central Nervous System Involvement at Baseline(Every three months up to death or study termination, a period of approximately 3.5 years)
- Progression-free Survival in Patients With Chemotherapy-free Interval ≥90 Days(Every six weeks up to progression disease, a period of approximately 3.5 years)
- Best Antitumor Response in Patients With Chemotherapy-free Interval ≥ 90 Days(Every three months up to death or study termination, a period of approximately 3.5 years)
- Overall Survival in Patients With Chemotherapy-free Interval < 90 Days(Every three months up to death or study termination, a period of approximately 3.5 years)
- Overall Response Rate in Patients With Chemotherapy-free Interval <90 Days(Every three months up to death or study termination, a period of approximately 3.5 years)
- Progression-free Survival in Patients Without Central Nervous System Involvement at Baseline(Every six weeks up to progression disease, a period of approximately 3.5 years)
- Best Antitumor Response in Patients Without Central Nervous System Involvement at Baseline(Every three months up to death or study termination, a period of approximately 3.5 years)
- Duration of Response in Patients With Chemotherapy-free Interval <90 Days(Every three months up to death or study termination, a period of approximately 3.5 years)
- Duration of Response in Patients With Central Nervous System Involvement at Baseline(Every three months up to death or study termination, a period of approximately 3.5 years)
- Duration of Response in Patients Without Central Nervous System Involvement at Baseline(Every three months up to death or study termination, a period of approximately 3.5 years)
- Progression-free Survival in Patients With Central Nervous System Involvement at Baseline(Every six weeks up to progression disease, a period of approximately 3.5 years)
- Overall Response Rate in Patients With Central Nervous System Involvement at Baseline(Every three months up to death or study termination, a period of approximately 3.5 years)
研究者
研究点 (160)
Loading locations...
相似试验
已完成
3 期
Doxorubicin Hydrochloride, Cyclophosphamide, and Pacltaxel With or Without Trastuzumab in Treating Women With HER2-Positive Node-Positive or High-Risk Node-Negative Breast CancerBreast AdenocarcinomaHER2 Positive Breast CarcinomaStage IA Breast Cancer AJCC v7Stage IB Breast Cancer AJCC v7Stage IIA Breast Cancer AJCC v6 and v7Stage IIB Breast Cancer AJCC v6 and v7Stage IIIA Breast Cancer AJCC v7NCT00005970National Cancer Institute (NCI)3,436
已完成
3 期
Clinical Trial of Lurbinectedin (PM01183) in Platinum Resistant Ovarian Cancer PatientsOvarian CancerNCT02421588PharmaMar442
进行中（未招募）
3 期
Doxorubicin Hydrochloride and Cyclophosphamide Followed by Paclitaxel With or Without Carboplatin in Treating Patients With Triple-Negative Breast CancerBreast AdenocarcinomaEstrogen Receptor NegativeHER2/Neu NegativeProgesterone Receptor NegativeStage IB Breast CancerStage IIA Breast CancerStage IIB Breast CancerStage IIIA Breast CancerStage IIIC Breast CancerTriple-Negative Breast CarcinomaNCT02488967NRG Oncology782
已完成
1 期
Study of Lurbinectedin (PM01183) in Combination With Capecitabine in Patients With Metastatic Breast Cancer (MBC), Pancreatic Cancer (PC) or Metastatic Colorectal Cancer (CRC).Metastatic Breast CancerMetastatic Colorectal CancerPancreatic CancerNCT02210364PharmaMar81
进行中（未招募）
3 期
Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast CancerBreast AdenocarcinomaNCT00433511National Cancer Institute (NCI)4,994