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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
All eligible patients after screening will receive up to four cycles chemotherapy. Recommended regimens are etoposide 100 mg/m2 intravenously on day 1-3 in combination with cisplatin 75 mg/m2 intravenously on day 1 or carboplatin AUC=5 every 3 weeks.
A total of 45Gy in 15 fractions over 3 weeks will be delivered. PCI is routinely scheduled for patients without progression after chemoradiotherapy, and hippocampal avoidance is highly recommended. 25Gy in 10 fractions over 2 weeks to the brain will be prescribed. Intensity modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT) technique are required. Patients without disease progression will receive an intravenous infusion of serplulimab 300mg every 3 weeks. Treatment of serplulimab should be continued until disease progression, intolerable toxicity, withdrawal of consent, or to a maximum of 1 year. Continuation of immunotherapy after disease progression is acceptable per investigators' discretion.
The investigator and IRRC respectively assess the tumor images according to RECIST 1.1.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated Radiotherapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX10 | Drug | HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. 300mg Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 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 | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival(OS) | Overall survival time is defined as the time from the date of the patient's first dose of HLX10 to the date of any documented death due to any cause. | up to 24 months |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nan Bi, Doctor | Contact | 86010-87788799 | binan_email@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Nan Bi, Doctor | Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiamusi Cancer Hospital | Recruiting | Jiamusi | Heilongjiang | 154007 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40398957 | Derived | Wu 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. |
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|
| hypofractionated radiotherapy | Radiation | 45Gy/3Gy/3week |
|
| Prophylactic Cranial Irradiation (PCI) | Radiation | 25Gy/2.5Gy/2week |
|
Proportion of subjects achieving a best response of complete response (CR) and partial response (PR) as assessed by RECIST 1.1.
| up to 24 months |
| Time to treatment failure (TTF) | Time to disease progression, death, withdrawal due to adverse events, patient refusal to continue the study, or use of a new treatment from the first HLX10 administration. | up to 12 months |
| Shanxi Province Cancer Hospital | Recruiting | Taiyuan | Shanxi | 030013 | China |
|
| ID | Term |
|---|---|
| D000069473 | Radiation Dose Hypofractionation |
| ID | Term |
|---|---|
| D019583 | Dose Fractionation, Radiation |
| D011879 | Radiotherapy Dosage |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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