DRKS00011857已完成3 期
Phase III Randomized Clinical Trial of Lurbinectedin (PM01183) plus Doxorubicin (DOX) versus Topotecan as Treatment in Patients with Small-Cell Lung Cancer (SCLC) Who Failed One Prior Platinum-containing Line (ATLANTIS Trial) - ATLANTIS
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 613
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •1) Voluntary written informed consent of the patient obtained
- •before any study-specific procedure.
- •2) Adult patients aged = 18 years.
- •3) 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.
- •4) ECOG PS = 2.
- •5) Adequate hematological, renal, metabolic and hepatic
- •function in an assessment performed within 7 days (+ 3 day
- •window) of randomization:
- •a) Hemoglobin = 9.0 g/dl [patients may have received prior
- •red blood cell (RBC) transfusion, if clinically indicated];
- •absolute neutrophil count (ANC) = 2.0 x 109/l, and
- •platelet count = 100 x 109/l.
- •b) Alanine aminotransferase (ALT) and aspartate
- •aminotransferase (AST) = 3.0 x upper limit of normal
- •c) Total bilirubin = 1.5 x ULN or direct bilirubin = ULN.
- •d) Albumin = 3.0 g/dl.
- •e) Calculated creatinine clearance (CrCL) = 30 ml/minute
- •(using Cockcroft and Gault’s formula).
- •f) Left ventricular ejection fraction (LVEF) by
- •echocardiogram (ECHO) or multiple-gated acquisition
- •(MUGA) scan within normal range (according to
- •institutional standards).
- •g) Creatine phosphokinase (CPK) = 2.5 x ULN (= 5.0 x
- •ULN is acceptable if elevation is disease-related).
- •6) At least three weeks since last prior anticancer treatment
- •and recovery to grade = 1 from any adverse event (AE)
- •related to previous anticancer treatment (excluding sensory
- •neuropathy, anemia, asthenia and alopecia, all grade = 2)
- •according to the National Cancer Institute Common
- •Terminology Criteria for Adverse Events (NCI-CTCAE,
- •7) Prior radiotherapy (RT): At least four weeks since
- •completion of whole-brain RT (WBRT), at least two weeks
- •since completion of prophylactic cranial irradiation (PCI),
- •and to any other site not previously specified.
- •8) 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 (IMP) dose.
排除标准
- •1) More than one prior chemotherapy-containing regimen
- •(including patients re-challenged with same initial
- •2) Patients who never received any platinum-containing
- •regimen for SCLC treatment.
- •3) Prior treatment with PM01183, topotecan or
- •anthracyclines.
- •4) Limited-stage patients who are candidates for local or
- •regional therapy, including PCI, thoracic RT or both, must
- •have been offered that option and completed treatment or
- •refused it prior to randomization.
- •5) Impending need for palliative RT or surgery for
- •pathological fractures and/or for medullary compression
- •within four weeks prior to randomization.
- •6) Symptomatic, or steroid-requiring, or progressing CNS
- •disease involvement during at least four weeks prior to
- •randomization (asymptomatic, non-progressing patients
- •taking steroids in the process of already being tapered
- •within two weeks prior to randomization are allowed).
- •7) Concomitant diseases/conditions:
- •a) History (within one year prior to randomization) or
- •presence of unstable angina, myocardial infarction,
- •congestive heart failure or clinically significant valvular
- •heart disease.
- •b) Symptomatic or uncontrolled arrhythmia despite
- •ongoing treatment.
- •c) Patients with any immunodeficiency, including those
- •known to be or have been infected by human
- •immunodeficiency virus (HIV).
- •d) Ongoing, treatment-requiring, non-neoplastic chronic
- •liver disease of any origin. For hepatitis B, this includes
- •positive tests for both Hepatitis B surface antigen
- •(HBsAg) and quantitative Hepatitis B polymerase chain
- •reaction (PCR). For hepatitis C, this includes positive
- •tests for both Hepatitis C antibody and quantitative
- •Hepatitis C PCR.
- •e) Active infection or increased risk due to external
- •f) Intermittent or continuous oxygen requirement within
- •two weeks prior to randomization. Patients with
- •confirmed or suspected diagnosis of diffuse interstitial
- •lung disease (ILD) or pulmonary fibrosis.
- •g) Patients with a second invasive malignancy treated with
- •chemotherapy and/or RT. Patients with a previous
- •malignancy that was completely resected with curative
- •intention three or more years prior to randomization, and
- •who has been continuously in remission since then will
- •be permitted.
- •h) Limitation of the patient’s ability to comply with the treatment or to follow the protocol.
- •i) Documented or suspected invasive fungal infections
- •requiring systemic treatment within 12 weeks of
- •randomization.
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