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

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Limited-Stage Small Cell Lung Cancer

In brief

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.

Key facts

Study ID

NCT05353257

Run by

Shanghai Henlius Biotech

People needed

511

Starts

2022-05-17

Expected to finish

2028-05-30

Last updated by the study team

2026-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Napa Research — Pompano Beach, Florida, United States
• Kansas University Mediacal Center — Fairway, Kansas, United States
• Hubei Cancer Hospital — Wuhan, Hubei, China
• Pontchartrain Cancer Center — Covington, Louisiana, United States
• Tulane University — New Orleans, Louisiana, United States
• Health Partners — Bloomington, Minnesota, United States
• Renown Health — Reno, Nevada, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• New York City Health+HospitalsCorporation Elmhurst Hospital Center — Elmhurst, New York, United States
• Northwell Health — Queens, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Cleveland Clinic Mercy Hospital — Canton, Ohio, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Tricounty Hematology and Oncology Associates — Massillon, Ohio, United States
• Kaiser Permanente Northwest — Portland, Oregon, United States
• OPN-Glendale — Arcadia, California, United States

Full record on ClinicalTrials.gov

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