Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of C
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
| Condition(s) | Small-cell Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: 1. Age between18 years and 80 years at time of study entry 2. ECOG performance status of 0 or 1 3. Body weight \>30 kg 4. Adequate bone marrow, liver and kidney function 5. Life expectancy of at least 3 months 6. At least one measurable (RECIST 1.1), thoracic lesion that can be irradiated with 45 Gy/15 fractions 7. Histologic or cytologic confirmation of small cell lung cancer 8. Stage III-IV disease (TNM v8) 9. Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value 10. 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: 1. Previous chemo-, immuno- or radiotherapy for SCLC 2. Major surg |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Lead sponsor | Ruijin Hospital |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2021-01-30 |
| NCT ID | NCT05552846 |
| Official listing | https://clinicaltrials.gov/study/NCT05552846 |