Evaluation of Systemic Effects of Combined Palliative Radiation Therapy and Immunotherapy in Patients with Metastatic Non-Small Cell Lung Cancer after Insufficient Response to Immune Checkpoint Blockade - RadImmun-NSCLC

niversitätsklinikum Freiburg, Klinik für Strahlenheilkunde0 个研究点目标入组 50 人开始时间: 2017年12月4日最近更新: 2024年8月19日

试验速览

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•Patients with metastatic NSCLC and progressive disease; At least three lesions measurable by computed tomography scan or magnetic resonance imaging; Patients presenting the indication for radiation therapy, with a minimum of 2 metastases not amenable to radiation therapy; Mixed or partial response under immunotherapy with checkpoint inhibitors; Minimum life expectancy of 3 months; Adequate bone marrow function; Adequate liver function; Written informed consent must be obtained according to ICH/GCP, and national/local regulations; Adequate birth control measures during the study treatment period.

•Age < 18 years; Central nervous system metastases mandating active treatment; ECOG performance status > 2; Female subjects who are pregnant; Patients under chronic treatment with systemic immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 1 week prior starting the study treatment; Patients with active, known, or suspected autoimmune disease; Other active or significantly bone marrow-suppressing malignancy or therapy; Known activating EGFR Mutation or a known ALK Translocation; Patients with previous malignancies; Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow-up.

发起方

niversitätsklinikum Freiburg, Klinik für Strahlenheilkunde