Spots Global Cancer Trial Database for SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy

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Trial Identification

Brief Title: SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy

Official Title: A Prospective Multi-center Phase II Study: Assessment of the Safety and Abscopal Effects of SBRT Combination With rhGM-CSF and Thymosin Alpha 1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy

Study ID: NCT02976740

Conditions

Lung Cancer Metastatic

Interventions

SBRT

Immunological Agent

Immunological Factors

Study Description

Brief Summary: The purpose of this study is to determine whether stereotactic body radiotherapy (SBRT) combined with recombined human granulocyte-macrophage colony stimulating factor(rhGM-CSF) and Thymosin Alpha 1 is safe, effective in the treatment of stage IV NSCLC patients who failed in second-line chemotherapy.

Detailed Description: Metastasis lesion of stage IV NSCLC will be treated with a SBRT of 50Gy/4-10F from day 1 to day 14 in one cycle. Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.Thymosin Alpha 1(1.6mg Biw) will be Subcutaneous injection from the fist week to the 12th weeks, Efficacy evaluation, especially abscopal effect evaluation, will be conducted at the end of therapy and every month after that. Adverse events will be recorded according to NCI-CTC version 4.03.