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
Sponsor: Shanghai Henlius Biotech
ClinicalTrials ID:NCT05353257
This phase III study evaluates Serplulimab with chemotherapy and radiotherapy in LS-SCLC patients. Participants are randomized into two arms: Serplulimab or placebo, both with chemotherapy and radiotherapy. Eligibility includes adults with stage I-III LS-SCLC and well-functioning organs. Exclusions include prior treatments and severe allergies. Interventions involve Serplulimab, chemotherapy, and thoracic radiotherapy.
Patient Parameters
| Parameter | Options |
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Program Overview
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.
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).
Eligibility Criteria
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| OPN-Glendale | 91007 | Arcadia | California |
| OPN-Los Alamitos | 90720 | Los Alamitos | California |
| Southern California Permanente Group | 90034 | Los Angeles | California |
| Emad Ibrahim, MD, Inc | 92373 | Redlands | California |
| Providence Medical Foundation | 95403 | Santa Rosa | California |
| Lutheran Medical Center - Cancer Centers of Colorado | 80401 | Golden | Colorado |
| Eastern Connecticut Hematology & Oncology Associates | 06360 | Norwich | Connecticut |
| Cancer Specialists of North Florida | 32257 | Jacksonville | Florida |
| Mid Florida Hematology and Oncology Center | 32763 | Orange City | Florida |
| Advent Health Orlando | 32804 | Orlando | Florida |
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