Radiotherapy for advanced small-cell lung cancer after chemotherapy
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
NA · Ruijin Hospital · NCT05552846
This study is testing if adding radiation therapy to ongoing treatment can help people with advanced small-cell lung cancer who haven't gotten worse after chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05552846 on ClinicalTrials.gov |
What this trial studies
This open-label, single-arm Phase II study aims to evaluate the efficacy and safety of thoracic radiotherapy in patients with extensive-stage small-cell lung cancer (ES-SCLC) who have not progressed after receiving standard chemo-immunotherapy. Participants will receive thoracic radiotherapy alongside PD-1/PD-L1 maintenance therapy for a minimum of six months. The study focuses on patients with measurable thoracic lesions who meet specific eligibility criteria, including adequate organ function and performance status.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with extensive-stage small-cell lung cancer who have not shown disease progression after initial chemotherapy and immunotherapy.
Not a fit: Patients who have previously received chemotherapy, immunotherapy, or radiotherapy for small-cell lung cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes and prolong survival for patients with advanced small-cell lung cancer.
How similar studies have performed: While there have been studies on radiotherapy in lung cancer, this specific approach combining thoracic radiotherapy with PD-1/PD-L1 maintenance therapy in ES-SCLC is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 surgical procedure last 28 days 3. History of allogenic organ transplantation, autoimmune disease, immunodeficiency, hepatitis or HIV 4. Uncontrolled intercurrent illness 5. Other active malignancy 6. Leptomeningeal carcinomatosis 7. Immunosuppressive medication 8. Pregnant or breastfeeding women
Where this trial is running
Shanghai, Shanghai Municipality
- Ruijin Hospital, Shanghai jiaotong univestigy school of medicine — Shanghai, Shanghai Municipality, China (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Small-cell Lung Cancer, thoradic radiotherapy, immune checkpoint inhibitors, chemo-immunotherapy