Clinical trial · Interventional
Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients
A Phase II Study of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer
NCT05443646CI-TRIAL-00076825unknownPhase 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 study is a multi-center, Single-arm Phase II study to evaluate the clinical efficacy and safety of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer
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 |
|---|---|---|---|
| Limited Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HLX10 | Drug | Serplulimab | ALIAS |
| hypofractionated radiotherapy | Radiation | — | UNRESOLVED |
| Prophylactic Cranial Irradiation (PCI) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated Radiotherapy
- description
- Participants will receive at least 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) concurrently with Hypofractionated Radiotherapy, followed by HLX10 300 mg every 3 weeks (Q3W) with maximum 1 years or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
- interventionNames
- Drug: HLX10
- Radiation: hypofractionated radiotherapy
- Radiation: Prophylactic Cranial Irradiation (PCI)
Primary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- up to 12 months
- description
- To evaluate the progression-free survival (PFS) of HLX10 (Serplulimab) consolidation therapy after concurrent hypofractionated radiotherapy with chemotherapy in limited-stage small cell lung cancer according to RECIST 1.1 criteria
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years; ECOG score 0-1. 2. Histologically or cytologically confirmed small cell lung cancer. 3. Limited stage, defined as the tumor confined to one side of the thoracic cavity including ipsilateral hilar, bilateral mediastinal, and bilateral supraclavicular lymph nodes, (metastatic lymph nodes are defined as short diameter ≥ 1 cm or increased metabolism on PET-CT considering metastatic lymph nodes); unless cytologically confirmed malignant pleural effusion, the thickness of pleural effusion on chest CT is less than 1 cm; (stage I-IIIB without intrapulmonary metastasis in the 7th edition of AJCC staging in 2009) . 4. No other previous anti-tumor history, at least 3 months of expected survival. 5. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function. Exclusion Criteria: 1. Histologically or cytologically confirmed mixed SCLC. 2. Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included. 3. Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy. 4. Patients with other active malignancies within 5 years or at the same time. 5. Subjects with known history of severe allergy to any monoclonal antibody. 6. Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide. 7. In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.
References
Publications (1)
- DERIVEDWu Y, Deng L, Wang J, Zhang T, Cao J, Zhou X, Duan J, Bi N. Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol. BMJ Open. 2025 May 21;15(5):e085552. doi: 10.1136/bmjopen-2024-085552. PMID 40398957