Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

Limited Stage Small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05443646
• Other study ID #: ASTRUM-LC01
• Status: Recruiting
• Phase: Phase 2
• Start date: September 23, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Nan Bi, Doctor
• Phone: 86010-87788799
• Email: binan_email[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18-75 years; ECOG score 0-1.

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:

1. Histologically or cytologically confirmed mixed SCLC.

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.

Related Conditions & MeSH terms

• Limited Stage Small Cell Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• HLX10
HLX10 is an innovative monoclonal antibody targeting PD-1,developed by Shanghai Henlius Biotech, Inc. 300mg Q3W

Radiation:
• hypofractionated radiotherapy
45Gy/3Gy/3week
• Prophylactic Cranial Irradiation (PCI)
25Gy/2.5Gy/2week

Locations

Country	Name	City	State
China	Jiamusi Cancer Hospital	Jiamusi	Heilongjiang
China	Shanxi Province Cancer Hospital	Taiyuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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