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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
55 participants
Sep 23, 2022
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Inclusion Criteria5
- Age 18-75 years; ECOG score 0-1.
- Histologically or cytologically confirmed small cell lung cancer.
- 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) .
- No other previous anti-tumor history, at least 3 months of expected survival.
- No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function.
Exclusion Criteria7
- Histologically or cytologically confirmed mixed SCLC.
- Subjects suitable for surgery. Subjects who are suitable for surgery but refuse surgical treatment can be included.
- Patients who have previously received systematic anti-tumor treatments for small cell lung cancer, including but not limited to radiotherapy, chemotherapy, and immunotherapy.
- Patients with other active malignancies within 5 years or at the same time.
- Subjects with known history of severe allergy to any monoclonal antibody.
- Subjects with known anaphylaxis to carboplatin/cisplatin or etoposide.
- In the judgment of the investigator, subjects who have any other factors that may lead to a premature discontinuation.
Interventions
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. 300mg Q3W
45Gy/3Gy/3week
25Gy/2.5Gy/2week
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT05443646