Consolidation Serplulimab Following Concurrent Chemoradiotherapy for LS-SCLC Patients

NCT05443646 | Recruiting Phase 2 DMC

• 1 other identifier: ASTRUM-LC01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

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

Conditions

Limited Stage Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Overall survival(OS）

  up to 24 months

• Objective response rate (ORR)

  up to 24 months

• Time to treatment failure (TTF)

  up to 12 months

Study Arms (1)

HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated Radiotherapy

EXPERIMENTAL

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; Radiation: hypofractionated radiotherapy; Radiation: Prophylactic Cranial Irradiation (PCI)

Interventions

HLX10 DRUG

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

Also known as: Serplulimab

HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated Radiotherapy

hypofractionated radiotherapy RADIATION

45Gy/3Gy/3week

HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated Radiotherapy

Prophylactic Cranial Irradiation (PCI) RADIATION

25Gy/2.5Gy/2week

HLX10 (Serplulimab) Consolidation After Chemotherapy Concurrent Hypofractionated Radiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (2)

Jiamusi Cancer Hospital

Jiamusi, Heilongjiang, 154007, China

RECRUITING

Shanxi Province Cancer Hospital

Taiyuan, Shanxi, 030013, China

RECRUITING

Related Publications (1)

• Wu Y, Deng L, Wang J, Zhang T, Cao J, Zhou X, Duan J, Bi N. Single-arm phase II study of consolidation serplulimab following hypofractionated radiotherapy with concurrent chemotherapy for patients with limited stage small-cell lung cancer: ASTRUM-LC01 study protocol. BMJ Open. 2025 May 21;15(5):e085552. doi: 10.1136/bmjopen-2024-085552.

  PMID: 40398957 DERIVED

MeSH Terms

Interventions

Radiation Dose Hypofractionation

Intervention Hierarchy (Ancestors)

Dose Fractionation, Radiation; Radiotherapy Dosage; Radiotherapy; Therapeutics

Study Officials

• Nan Bi, Doctor

  Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nan Bi, Doctor

CONTACT

86010-87788799; binan_email@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 5, 2022
• Study Start: September 23, 2022
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)