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

Phase 3

Active, not recruiting

• Conditions: Limited-Stage Small Cell Lung Cancer
• Interventions: Drug: HLX10; Drug: carboplatin/cisplatin-etoposide; Radiation: Thoracic radiotherapy; Drug: Placebo; Radiation: Prophylactic Cranial Irradiation (PCI)

• Registration Number: NCT05353257
• Lead Sponsor: Shanghai Henlius Biotech

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 Timeline

• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-04-25
• Study First Posted: 2022-04-29
• Study Start: 2022-05-17
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-28
• Primary Completion: 2025-07-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 511

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy	Thoracic 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.
Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy	carboplatin/cisplatin-etoposide	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.
placebo + carboplatin/cisplatin-etoposide + radiotherapy	carboplatin/cisplatin-etoposide	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.
Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy	HLX10	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.
Serplulimab + carboplatin/cisplatin-etoposide + radiotherapy	Prophylactic Cranial Irradiation (PCI)	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.
placebo + carboplatin/cisplatin-etoposide + radiotherapy	Thoracic 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.
placebo + carboplatin/cisplatin-etoposide + radiotherapy	Placebo	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.
placebo + carboplatin/cisplatin-etoposide + radiotherapy	Prophylactic Cranial Irradiation (PCI)	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.

Primary Outcome Measures

Name	Time	Method
Overall survival(OS	up to 36 months	the time from randomization to death due to any cause

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	up to approximately 24months	PFS, assessed by the investigator as per RECIST v1.1

Trial Locations

Locations (128)

OPN-Glendale; 🇺🇸 Arcadia, California, United States

OPN-Los Alamitos; 🇺🇸 Los Alamitos, California, United States

Southern California Permanente Group; 🇺🇸 Los Angeles, California, United States

Emad Ibrahim, MD, Inc; 🇺🇸 Redlands, California, United States

Providence Medical Foundation; 🇺🇸 Santa Rosa, California, United States

Lutheran Medical Center - Cancer Centers of Colorado; 🇺🇸 Golden, Colorado, United States

Eastern Connecticut Hematology & Oncology Associates; 🇺🇸 Norwich, Connecticut, United States

Cancer Specialists of North Florida; 🇺🇸 Jacksonville, Florida, United States

Mid Florida Hematology and Oncology Center; 🇺🇸 Orange City, Florida, United States

Advent Health Orlando; 🇺🇸 Orlando, Florida, United States

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