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

Purpose

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

  • Limited-Stage Small Cell Lung Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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: HLX10
    Serplulimab is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc. 300mg Q3W
    Other names:
    • 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
  • 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.

Recruiting Locations

Tulane University
New Orleans, Louisiana 70112
Contact:
Mark Sides
504-988-6770

More Details

Status
Recruiting
Sponsor
Shanghai Henlius Biotech

Study Contact

Jinming Yu, MD
138064066293
sdyujinming@126.com

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).