Overview
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
Description
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 4 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.
Eligibility
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