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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 : October 10, 2023
Sponsor:
Information provided by (Responsible Party):
Shanghai Henlius Biotech

Study Description
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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.

Condition or disease Intervention/treatment Phase
Limited-Stage Small Cell Lung Cancer Drug: Serplulimab Drug: carboplatin/cisplatin-etoposide Radiation: Thoracic radiotherapy Drug: Placebo Radiation: Prophylactic Cranial Irradiation (PCI) Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 482 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : May 17, 2022
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Serplulimab

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

300mg Q3W


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

Radiation: Prophylactic Cranial Irradiation (PCI)
PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.
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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival(OS [ Time Frame: up to 36 months ]
    the time from randomization to death due to any cause


Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: up to approximately 24months ]
    PFS, assessed by the investigator as per RECIST v1.1


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05353257


Contacts
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Contact: Jinming Yu, MD 138064066293 sdyujinming@126.com
Contact: Ying Cheng 0431-80596315 jl.cheng@163.com

Locations
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Sponsors and Collaborators
Shanghai Henlius Biotech
Investigators
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Principal Investigator: Jinming Yu, MD Shandong Cancer Hospital & Institute-department
Principal Investigator: Ying Cheng Jilin Provincial Tumor Hospital
More Information
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Responsible Party: Shanghai Henlius Biotech
ClinicalTrials.gov Identifier: NCT05353257    
Other Study ID Numbers: HLX10-020-SCLC302
First Posted: April 29, 2022    Key Record Dates
Last Update Posted: October 10, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Henlius Biotech:
Limited-Stage Small Cell Lung Cancer
Serplulimab
Additional relevant MeSH terms:
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Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
 Bronchial Neoplasms
Carboplatin
Etoposide
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action