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 (ATLANTIS Trial) - ATLANTIS Trial

PHARMA MAR, S.A. SOCIEDAD UNIPERSONA0 个研究点目标入组 600 人开始时间: 2021年2月9日最近更新: 2021年4月5日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 600

研究概览入排标准研究者记录与标识符相似试验

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) 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, v.4).
•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. Valid methods to determine the childbearing potential, adequate contraception and requirements for WOCBP partners. Fertile male patients with WOCBP partners should use condoms during treatment and for four months following the last investigational medicinal product (IMP) dose.
•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 200
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 400

排除标准

•1) More than one prior chemotherapy-containing regimen (including patients re-challenged with same initial regimen).
•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

研究者

发起方

PHARMA MAR, S.A. SOCIEDAD UNIPERSONA

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