First line Immunotherapy-chemotherapy versus Immunotherapy-chemotherapy Combined With Stereotactic Body Radiation for Metastatic NSCLC patients: A Phase II Randomized, Open Label Clinical Trial. - ICSMEN-Trial

AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA0 个研究点目标入组 132 人开始时间: 2021年10月12日最近更新: 2022年3月14日

适应症

试验速览

暂无简介。

•- Histologic confirmation of NSCLC by biopsy or cytology (primary cancer are eligible: squamous cell carcinoma, adenocarcinoma; no sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) gene translocation; stage IV according to the 8th version of the IASLC system);
•- Age >= 18 years;
•- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
•- At least two lesions measurable according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
•- Life expectancy of at least 3 months;
•- Signature of informed consent form;
•- Patients must have adequate organ function.
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 32

•- Eastern Cooperative Oncology Group (ECOG) performance status score >2;
•- Patients scheduled to receive other concomitant local therapy (including standard fractionated radiation therapy and surgery) during this protocol, except at disease progression;
•- Mandatory detention for treatment of a psychiatric or physical illness;
•- Pregnancy or lactating (because treatment carries unpredictable risks to the embryo or fetus);
•- Previous immunotherapy with PD1 or CTLA4 antibodies;
•- Known or suspected active autoimmune disease;
•- History of antibodies to human immunodeficiency virus (HIV) -1 or -2;
•- Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection;
•- Patients who are unable to receive chemotherapy;
•- Conditions requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days of study drug administration;
•- Allergies or adverse drug reactions;
•- Contraindications to radiation therapy;
•- History of idiopathic pulmonary fibrosis, including pneumonitis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan

发起方

AZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA