Sequential Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Inhibitor Maintenance Therapy:a Phase II, Single Arm, Prospective Trial
This is an open-label, single arm Phase II study designed to observe and evaluate the efficacy and safety of sequential thoracic radiotherapy in the first-line treatment of extensive small cell lung cancer with chemotherapy combined with approved PD-1/PD-L1 inhibitors.
• Age between18 years and 75 years.
• Histologic or cytologic confirmation of extensive-stage small cell lung cancer.
• Initially treated patients with extensive SCLC showed no disease progression after 4-6 cycles of chemotherapy combined with PD-1/PD-L1 inhibitors.
• Presence of at least one measurable lesion (according to RECIST v1.1).
• ECOG performance status of 0 or 1.
• Life expectancy of at least 3 months.
• Adequate bone marrow, liver and kidney function.
• Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value