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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Limited-Stage Small Cell Lung Cancer

Intervention / Treatment
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* Drug: HLX10
* Drug: carboplatin/cisplatin-etoposide
* Radiation: Thoracic radiotherapy
* Drug: Placebo
* Radiation: Prophylactic Cranial Irradiation (PCI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged ≥18 years when signing the ICF. Histologically diagnosed with SCLC. 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. Major organs are functioning well. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy<br>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: HLX10<br>* Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. 300mg Q3W<br>* Other names: Serplulimab;Drug: carboplatin/cisplatin-etoposide<br>* 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.<br>Radiation: Thoracic radiotherapy<br>* Standard Thoracic Radiotherapy<br>Radiation: Prophylactic Cranial Irradiation (PCI)<br>* PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.<br>|
| Placebo Comparator: placebo + carboplatin/cisplatin-etoposide + radiotherapy<br>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<br>* 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.<br>Radiation: Thoracic radiotherapy<br>* Standard Thoracic Radiotherapy<br>Drug: Placebo<br>* Placebo Q3W<br>Radiation: Prophylactic Cranial Irradiation (PCI)<br>* PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival(OS | the time from randomization to death due to any cause | up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | PFS, assessed by the investigator as per RECIST v1.1 | up to approximately 24months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Limited-Stage Small Cell Lung Cancer, Serplulimab