NCT05552846Recruiting
Phase II Trial of Consolidative Thoracic Radiotherapy for ES-SCLC After Standard Care of Chemo-immunotherapy
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
Source: ClinicalTrials.gov · Last updated 12 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 104 (estimated)
- First submitted
- 21 Sept 2022
- Start date
- 30 Jan 2021
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Ruijin Hospital
- Diseases
- Lung cancer
- NCT number
- NCT05552846
What you commit to
- Study type: Interventional
- Planned participants: 104
- From 30 Jan 2021 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous chemo-, immuno- or radiotherapy for SCLC
- Major surgical procedure last 28 days
- Immunosuppressive medication
Other illness
- History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV
- Uncontrolled intercurrent illness
- Other active malignancy
Other
- Leptomeningeal carcinomatosis
- Pregnant or breastfeeding women
Who the study is looking for
- 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 -
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital, Shanghai jiaotong univestigy school of medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.