Clinical trial · Interventional
Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC
Phase II, Single-Arm Study of Low-Dose Radiotherapy (LDRT) Concurrent Cisplatin/Carboplatin Plus Etoposide With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer
NCT05765825CI-TRIAL-00109827active not recruitingPhase 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 a Phase II, single arm, multicenter study designed to evaluate the safety and efficacy of low-dose radiotherapy (LDRT) concurrent cisplatin/carboplatin plus etoposide with serplulimab in participants who have extensive-stage small cell lung cancer (ES-SCLC) and are chemotherapy-navïe for their extensive-stage disease.
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 (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| serplulimab | Drug | Serplulimab | ALIAS |
| Thoracic radiation therapy (TRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- LDRT concurrent cisplatin/carboplatin + etoposide + serplulimab
- description
- Participants will receive the following treatment regimens: The induction period consists of 4 cycles of 21 days each. Low-dose radiotherapy(LDRT) at 15Gy/5f will be performed concurrently from Day 1 to Day 5 (D1-D5) of Cycle 1. An efficacy assessment will be performed at the end of Cycle 2. For patients with primary lung lesions (intrathoracic lesions) evaluated as small PR (tumor shrinkage \< 80%)/SD/PD, ldrt at 15Gy/5f will be performed in addition to serplulimab with chemotherapy in Cycle 3. For subjects evaluated as PD/SD/PR with extrathoracic residual metastases, ldrt at 15Gy/5f will be performed in addition to serplulimab with chemotherapy in Cycle 4. After the induction period, the subjects will continue to receive maintenance treatment with serplulimab.
- interventionNames
- Drug: serplulimab
- Drug: Cisplatin
- Drug: Carboplatin
- Drug: Etoposide
- Radiation: Thoracic radiation therapy (TRT)
Primary outcomes (1)
- measure
- Progression-free survival (PFS)
- timeFrame
- Baseline up to approximately 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main Inclusion Criteria: 1. Histologically or cytologically confirmed ES-SCLC 2. No prior treatment for ES-SCLC 3. Measurable disease, as defined by RECIST v1.1. Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation. 4. ECOG performance status of 0 or 1 5. Life expectancy \>= 3 months 6. Adequate hematologic and end-organ function 7. For participants receiving therapeutic anticoagulation: stable anticoagulant regimen 8. Negative human immunodeficiency virus (HIV) test at screening 9. Negative hepatitis B surface antigen (HBsAg) test at screening 10. Positive hepatitis B surface antibody (HBsAb) test at screening, or negative HBsAb at screening accompanied by either of the following: Negative total hepatitis B core antibody (HBcAb), or positive total HBcAb test followed by a negative hepatitis B virus (HBV) DNA test. The HBV DNA test will be performed only for participants who have a negative HBsAg test, a negative HBsAb test, and a positive total HBcAb test. 11. Negative hepatitis C virus (HCV) antibody test at screening, or positive HCV antibody test followed by a negative HCV RNA test at screening. The HCV RNA test will be performed only for participants who have a positive HCV antibody test. 12. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception 13. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm Main Exclusion Criteria: 1. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases 2. Participants with pulmonary artery invasion 3. History of leptomeningeal disease 4. Uncontrolled tumor-related pain 5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures 6. Uncontrolled or symptomatic hypercalcemia 7. Active or history of autoimmune disease or immune deficiency 8. History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan 9. Active tuberculosis 10. Significant cardiovascular disease within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina 11. History of malignancy other than small cell lung cancer (SCLC) within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
References
Publications (0)
Data not yet available
No reference posted for this study.