Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy

This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD (determined as per the RECIST v1.1) after 6 cycle of platinum-based chemotherapy in combination with an anti-PD-1/L1. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy, and the total maintenance therapy time should at least more than 6 months.

Inclusion criteria

• 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 -

Exclusion criteria

• Previous chemo-, immuno- or radiotherapy for SCLC
• Major surgical procedure last 28 days
• History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
• Uncontrolled intercurrent illness
• Other active malignancy
• Leptomeningeal carcinomatosis
• Immunosuppressive medication
• Pregnant or breastfeeding women