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)

Hospital de Caridade de Ijui0 个研究点开始时间: 2017年10月23日最近更新: 2023年5月29日

适应症

试验速览

阶段: 3 期
状态: 尚未招募
发起方

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: Intervention

入排标准

入选标准

•Voluntary written informed consent of the patient; Adult patients aged more than 18 years; Diagnosis of limited or extensive stage small cells lung cancer (SCLC); Small-cell carcinoma of unknown primary site with or without neuroendocrine; ECOG PS lower than 2; Adequate hematological, renal, metabolic and hepatic function in an assessment performed within 7 days (+ 3 day window) of randomization;At least three weeks since last prior anticancer treatment and recovery to grade less than 1 from any AE related to previous anticancer treatment;Prior Radiotheraphy (RT): At least four weeks since completion of whole-brain RT (WBRT), at least two weeks since completion of PCI, and to any other site not previously specified; 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.

排除标准

•More than one prior chemotherapy-containing regimen (including patients re-challenged with same initial regimen);
•Patients who never received any platinum-containing regimen for SCLC treatment;
•Prior treatment with PM01183, topotecan or anthracyclines;
•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;
•Impending need for palliative RT or surgery for pathological fractures and/or for medullary compression within four weeks prior to randomization;
•Symptomatic, or steroid-requiring, or progressing CNS disease involvement during at least four weeks prior to randomization; Concomitant diseases/conditions:
•History (within one year prior to randomization) or presence of unstable angina, myocardial infarction, congestive heart failure or clinically significant valvular heart disease;
•Symptomatic or uncontrolled arrhythmia despite ongoing treatment;
•Patients with any immunodeficiency, including those known to be or have been infected by human immunodeficiency virus (HIV);
•Ongoing, treatment-requiring, non-neoplastic chronic liver disease of any origin,Active infection or increased risk due to external drainages, 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, 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, Limitation of the patient’s ability to comply with the treatment or to follow the protocol, Documented or suspected invasive fungal infections requiring systemic treatment within 12 weeks of randomization; Pregnant or breast feeding women.

研究者

发起方

Hospital de Caridade de Ijui

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