Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients
NCT ID: NCT05443646
Last Updated: 2024-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
55 participants
INTERVENTIONAL
2022-09-23
2025-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated Radiotherapy
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.
HLX10
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
300mg Q3W
hypofractionated radiotherapy
45Gy/3Gy/3week
Prophylactic Cranial Irradiation (PCI)
25Gy/2.5Gy/2week
Interventions
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HLX10
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
300mg Q3W
hypofractionated radiotherapy
45Gy/3Gy/3week
Prophylactic Cranial Irradiation (PCI)
25Gy/2.5Gy/2week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Cancer Institute and Hospital, Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Nan Bi, Doctor
Role: PRINCIPAL_INVESTIGATOR
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Locations
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Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, China
Shanxi Province Cancer Hospital
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Xiaohong Zhou
Role: primary
Jianzhong Cao
Role: primary
References
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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.
Other Identifiers
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ASTRUM-LC01
Identifier Type: -
Identifier Source: org_study_id
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