A Phase II, Open-Label, Multi-Arm Study to Determine the PreliminaryEfficacy of Novel Combinations of Treatment in Patients with PlatinumRefractory Extensive-Stage Small-Cell Lung Cancer

AstraZeneca AB0 个研究点目标入组 40 人开始时间: 2016年11月21日最近更新: 2024年1月8日

适应症

试验速览

暂无简介。

•1.Histologically or cytologically documented extensive disease American Joint Committee on Cancer Stage IV SCLC (T any, N any, M1 a/b), including patients with:
•T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan.
•Biopsy-proven mixed SCLC and NSCLC histology
•Brain metastases; must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment. Patients with suspected brain metastases at screening should have a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry.
•2.Patients must have demonstrated progressive disease (PD) either during first-line platinum-based chemotherapy (platinum refractory) or within 90 days of completing platinum-based chemotherapy (platinum resistant), and have not received further treatment apart from first-line platinum-based chemotherapy.
•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 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•1.Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the IP or interpretation of patient safety or study results, including but not limited to ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs from the study medications, or compromise the ability of the patient to give written informed consent.
•2. Past medical history of interstitial lung disease, drug-induced pneumonitis, radiation pneumonitis that required steroid treatment, or any evidence of clinically active interstitial lung disease.

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