A Phase II Study of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer（ASTRUM-LC01）

Study Overview
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Brief Summary
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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

Official Title
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A Phase II Study of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer

Conditions
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Limited Stage Small Cell Lung Cancer

Intervention / Treatment
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* Drug: HLX10
* Radiation: hypofractionated radiotherapy
* Radiation: Prophylactic Cranial Irradiation (PCI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated Radiotherapy<br>Participants will receive 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. | Drug: HLX10<br>* HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. 300mg Q3W<br>* Other names: Serplulimab;Radiation: hypofractionated radiotherapy<br>* 45Gy/1.5F/3week<br>Radiation: Prophylactic Cranial Irradiation (PCI)<br>* 25Gy/2.5Gy/2week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 |