Back to resultsA Phase II Study of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer（ASTRUM-LC01）
Primary Purpose
Limited Stage Small Cell Lung Cancer
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
HLX10
hypofractionated radiotherapy
Prophylactic Cranial Irradiation (PCI)
Sponsored by
About this trial
This is an interventional treatment trial for Limited Stage Small Cell Lung Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated Radiotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT05443646
First Posted
June 29, 2022
Last Updated
June 29, 2022
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05443646
Brief Title
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）
Official Title
A Phase II Study of Consolidation HLX10 (Serplulimab) Following Hypofractionated Radiotherapy With Concurrent Chemotherapy for Patients With Limited Stage Small Cell Lung Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2022 (Anticipated)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Limited Stage Small Cell Lung Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated Radiotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
HLX10
Other Intervention Name(s)
Serplulimab
Intervention Description
HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
300mg Q3W
Intervention Type
Radiation
Intervention Name(s)
hypofractionated radiotherapy
Intervention Description
45Gy/1.5F/3week
Intervention Type
Radiation
Intervention Name(s)
Prophylactic Cranial Irradiation (PCI)
Intervention Description
25Gy/2.5Gy/2week
Primary Outcome Measure Information:
Title
Progression-free survival
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
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Overall survival(OS）
Description
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.
Time Frame
up to 24 months
Title
Objective response rate (ORR)
Description
Proportion of subjects achieving a best response of complete response (CR) and partial response (PR) as assessed by RECIST 1.1.
Time Frame
up to 24 months
Title
Time to treatment failure (TTF)
Description
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.
Time Frame
up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nan Bi, Doctor
Phone
86010-87788799
Email
binan_email@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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）
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