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

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

Study Overview

• Status: Recruiting
• Conditions: Limited Stage Small Cell Lung Cancer
• Intervention / Treatment: Drug: HLX10; Radiation: Prophylactic Cranial Irradiation (PCI); Radiation: hypofractionated radiotherapy

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 55
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nan Bi, Doctor; Phone Number: 86010-87788799; Email: binan_email@163.com

Study Locations

• China
  • Heilongjiang
    • Jiamusi, Heilongjiang, China, 154007
      • Recruiting
      • Jiamusi Cancer Hospital
      • Contact: Xiaohong Zhou
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Recruiting
      • Shanxi Province Cancer Hospital
      • Contact: Jianzhong Cao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: HLX10; HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. 300mg Q3W; Other Names: Serplulimab; Radiation: Prophylactic Cranial Irradiation (PCI); 25Gy/2.5Gy/2week; Radiation: hypofractionated radiotherapy; 45Gy/3Gy/3week

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Nan Bi, Doctor, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: June 29, 2022
• First Submitted That Met QC Criteria: June 29, 2022
• First Posted (Actual): July 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: ASTRUM-LC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No