Consolidative Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Maintenance Therapy:an Open Label, Single Arm Prospective Trial
This is an open-label, single arm Phase II study designed to evaluate the efficacy and safety of thoracic radiotherapy for extensive-stage small-cell lung cancer treated with PD-1/PD-L1 plus etoposide platinum followed by PD-1/PD-L1 maintenance therapy
• Age between18 years and 80 years at time of study entry
• ECOG performance status of 0 or 1
• Body weight \>30 kg
• Adequate bone marrow, liver and kidney function
• Life expectancy of at least 3 months
• At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 45 Gy/15 fractions
• Histologic or cytologic confirmation of small cell lung cancer
• Stage III-IV disease (TNM v8)
• Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value
⁃ Patients with brain metastases are eligible provided they are asymptomatic or treated and stable on steroids and/or anticonvulsants prior to the start of treatment -