Clinical trial · Interventional
First-line Treatment for ES-SCLC with Chemotherapy Combined with PD-1/PD-L1 Inhibitor Sequential Thoracic Radiotherapy
Sequential Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Inhibitor Maintenance Therapy:a Phase II, Single Arm, Prospective Trial
NCT06586697CI-TRIAL-00080779unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, single arm Phase II study designed to observe and evaluate the efficacy and safety of sequential thoracic radiotherapy in the first-line treatment of extensive small cell lung cancer with chemotherapy combined with approved PD-1/PD-L1 inhibitors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extensive-stage Small-cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Thoracic Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Thoracic Radiotherapy
- description
- Thoracic Radiotherapy (45Gy /1.5Gy/bid/3w)
- interventionNames
- Radiation: Thoracic Radiotherapy
Primary outcomes (1)
- measure
- progression-free survival rate at 6-month
- timeFrame
- 12 months after last patient entry
- description
- PFS is defined as the period from the start of receiving the first line chemotherapy plus PD-1/PD-L1 inhibitor to disease progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between18 years and 75 years. 2. Histologic or cytologic confirmation of extensive-stage small cell lung cancer. 3. Initially treated patients with extensive SCLC showed no disease progression after 4-6 cycles of chemotherapy combined with PD-1/PD-L1 inhibitors. 4. Presence of at least one measurable lesion (according to RECIST v1.1). 5. ECOG performance status of 0 or 1. 6. Life expectancy of at least 3 months. 7. Adequate bone marrow, liver and kidney function. 8. Adequate pulmonary function with FEV1 \>1 L or \>30 % of predicted value and DLCO \>30 % of predicted value Exclusion Criteria: 1. Previous T cell co-stimulation or immune checkpoint therapy. 2. Previous received chemoradiotherapy for limited-stage SCLC. 3. Central nervous system metastasis with clinical symptoms. 4. Multiple liver metastases (patients with isolated liver metastases, metastatic lesions \< 3cm could be included). 5. Patients with spinal cord compression. 6. Idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia during screening (patients with active pulmonary tuberculosis couldn't be enrolled). 7. Have received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the informed consent. 8. In the 5 years prior to the study, subjects had prior or concurrent malignancies requiring active treatment. 9. Subjects with any severe and/or uncontrolled disease (hypertension, heart disease, infection, cirrhosis, active hepatitis, AIDS, third space effusion). 10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 11. Severe allergic reactions to any of the monoclonal antibodies are known to occur.
References
Publications (0)
Data not yet available
No reference posted for this study.