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A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05353257
Recruitment Status : Recruiting
First Posted : April 29, 2022
Last Update Posted : March 4, 2024
Sponsor:
Information provided by (Responsible Party):
Shanghai Henlius Biotech

Tracking Information
First Submitted Date  ICMJE April 25, 2022
First Posted Date  ICMJE April 29, 2022
Last Update Posted Date March 4, 2024
Actual Study Start Date  ICMJE May 17, 2022
Estimated Primary Completion Date December 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 25, 2022)		 Overall survival(OS [ Time Frame: up to 36 months ]
the time from randomization to death due to any cause
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 25, 2022)		 Progression-free survival [ Time Frame: up to approximately 24months ]
PFS, assessed by the investigator as per RECIST v1.1
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Serplulimab in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer
Official Title  ICMJE A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer
Brief Summary This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.
Detailed Description

Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.

Arm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Limited-Stage Small Cell Lung Cancer
Intervention  ICMJE
  • Drug: HLX10

    Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.

    300mg Q3W

    Other Name: Serplulimab
  • Drug: carboplatin/cisplatin-etoposide

    Etoposide: 100 mg/m2, IV, on Days 1, 2, and 3 of each cycle. Carboplatin: AUC = 5, IV, on Day 1 of each cycle up to a dose of 750 mg. investigator's choice.

    Cisplatin: 75mg/m2, IV, on Days 1 of each cycle. investigator's choice.

  • Radiation: Thoracic radiotherapy
    Standard Thoracic Radiotherapy
  • Drug: Placebo
    Placebo Q3W
  • Radiation: Prophylactic Cranial Irradiation (PCI)
    PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
Study Arms  ICMJE
  • Experimental: Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy
    Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus Serplulimab 300 mg every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
    Interventions:
    • Drug: HLX10
    • Drug: carboplatin/cisplatin-etoposide
    • Radiation: Thoracic radiotherapy
    • Radiation: Prophylactic Cranial Irradiation (PCI)
  • Placebo Comparator: placebo + carboplatin/cisplatin-etoposide + radiotherapy
    Participants will receive 4 cycles of standard-of-care chemotherapy (carboplatin/cisplatin-etoposide) plus placebo every 3 weeks (Q3W) concurrently with standard thoracic radiotherapy, with maximum 1 year after completion of cCRT or until disease progression, intolerable toxicity or other reasons specified in the protocol, whichever occurs first.
    Interventions:
    • Drug: carboplatin/cisplatin-etoposide
    • Radiation: Thoracic radiotherapy
    • Drug: Placebo
    • Radiation: Prophylactic Cranial Irradiation (PCI)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 25, 2022)		 482
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2026
Estimated Primary Completion Date December 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female, aged ≥18 years when signing the ICF.
  2. Histologically diagnosed with SCLC.
  3. Diagnosed with LS-SCLC (stage Ⅰ-Ⅲ of the AJCC 8th edition of the cancer staging), which can be safely treated with curative radiation doses.
  4. Major organs are functioning well.

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Jinming Yu, MD 138064066293 sdyujinming@126.com
Contact: Ying Cheng 0431-80596315 jl.cheng@163.com
Listed Location Countries  ICMJE Austria,   China,   Czechia,   Germany,   Greece,   Hungary,   Latvia,   Netherlands,   Poland,   Spain,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05353257
Other Study ID Numbers  ICMJE HLX10-020-SCLC302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Shanghai Henlius Biotech
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Shanghai Henlius Biotech
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jinming Yu, MD Shandong Cancer Hospital & Institute-department
Principal Investigator: Ying Cheng Jilin Provincial Tumor Hospital
PRS Account Shanghai Henlius Biotech
Verification Date February 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP