Clinical trial · Interventional
Thoracic Consolidation Radiotherapy for ES-SCLC Treated With Chemo-immunotherapy
A Phase I Dose Escalation Study of Thoracic Consolidation Radiotherapy for Extensive-stage Small Cell Lung Cancer Patients Treated With Chemo-immunotherapy
NCT06187740CI-TRIAL-00072821unknownPhase 1ClinicalTrials.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 study intends to recruit ES-SCLC patients with response to standard first-line chemo-immunotherapy to assess the safety of receiving different doses of consolidative thoracic radiotherapy.
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 |
|---|---|---|---|
| Small Cell Lung Cancer Extensive Stage | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| thoracic radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Starting Dose, Arm 1
- description
- For ES-SCLC patients who completed first-line four-cycle chemo-immunotherapy, and was evaluated to have any response to treatment. Thoracic radiotherapy is administered to treat residual thoracic lesions during immunotherapy maintenance phase. Thoracic radiotherapy should begin within 42 days after the end of the last chemotherapy at an initial dose of 30 Gy in 10 fractions (3 patients).
- interventionNames
- Radiation: thoracic radiotherapy
- type
- EXPERIMENTAL
- label
- Dose escalation 1, Arm 2
- description
- Dose escalation will start after acceptable safety was observed, first at: 35 Gy/10 Fx (3 patients). Radiotherapy was administered between two immunotherapy doses (3 weeks interval) to avoid thoracic radiotherapy on the same day with immunotherapy. Immunotherapy was maintained until disease progression or the investigator 's judgment there was no further benefit from immunotherapy, patient died, intolerable toxicity developed. Toxicities were assessed periodically during the study. Local radiotherapy is permitted for symptomatic brain/bone metastases.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion criteria: 1. age ≥ 18 years; 2. ECOG performance status score 0-2 points; 3. pathologically confirmed small cell lung cancer; 4. complete baseline imaging data (including brain enhanced MRI/CT, PET-CT or chest enhanced CT + bone scan + neck and abdominal B ultrasound/CT) before first-line treatment; 5. stage extensive-stage SCLC at initial diagnosis, and first-line treatment received standard platinum-based doublet chemotherapy combined with immunotherapy (PD-1 or PD-L1) for at least 4 cycles after the efficacy assessment of SD or PR (residual lesions assessed by chest CT); 6. no history of other malignancies; 7. reproductive age male/female agreed to contraception during the trial (surgical ligation or oral contraceptives/intrauterine devices + condom contraception); 8. life expectancy ≥ 3 months 9. 1 week before enrollment, the investigator judged that the patient could continue immune maintenance therapy at the same time, And the organ function level meets the following criteria: 1\) bone marrow function: hemoglobin ≥ 80 g/L, white blood cell count ≥ 4.0 \* 10 \^ 9/L or neutrophil count ≥ 1.5 \* 10 \^ 9/L, platelet count ≥ 100 \* 10 \^ 9/L; 2) liver: serum total bilirubin level ≤ 1.5 times the upper limit of normal, when serum total bilirubin level \> 1.5 times the upper limit of normal direct bilirubin level must be ≤ the upper limit of normal,Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times of the upper limit of normal; serum albumin ≥ 27 g/L; 3) Kidney: serum creatinine level \< 1.5 times of the upper limit of normal or creatinine clearance ≥ 50 ml/min, urea nitrogen ≤ 200 mg/L; 10.Patients must have the ability to understand and voluntarily sign an informed consent form. Exclusion Criteria: 1. baseline pathological examination found mixed with non-small cell lung cancer components; 2. patients who had used any anti-tumor therapy before the diagnosis of ES-SCLC; 3. patients who had received anti-tumor therapy other than standard chemotherapy + immunotherapy regimen; 4. patients who had PD assessed by chemotherapy combined with immunotherapy efficacy; 5. patients who had no residual thoracic lesions (lung, mediastinal and supraclavicular metastatic lymph nodes, thoracic efficacy CR) on chest enhanced CT during efficacy assessment; 6. patients with severe immune-related toxicities after treatment; 7. symptomatic interstitial lung disease or active infection/non-infectious pneumonia; 8. patients who required long-term use of cortisol or immunosuppressive agents; 9. allergic to PD-1 or PD-L1 monoclonal antibody immunotherapy or other causes of inability to perform immune maintenance therapy; 10. lactating or pregnant women; 11. patients with severe autoimmune diseases: active inflammatory bowel disease (including Crohn 's disease, ulcerative colitis), rheumatoid arthritis, scleroderma, systemic lupus erythematosus, autoimmune vasculitis (such as Wegener' s granulomatosis), etc.; 12. researchers believe that physical examination or clinical trials may interfere with the results or increase the risk of treatment complications, or other uncontrollable diseases; 13. patients with mental illness, substance abuse, social problems affecting compliance are not enrolled after the doctor 's review.
References
Publications (0)
Data not yet available
No reference posted for this study.