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

NCT05353257 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Henlius Biotech

Phase

Phase 3

Started

2022-05-17

Last updated

2026-01-13

Condition(s) studied

Limited-Stage Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

HLX10carboplatin/cisplatin-etoposideThoracic radiotherapyPlaceboProphylactic Cranial Irradiation (PCI)

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

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.

Thoracic radiotherapy: Standard Thoracic Radiotherapy

Placebo: Placebo Q3W

Prophylactic Cranial Irradiation (PCI): PCI will be strongly recommended for participants who achieve CR or PR after completion of chemoradiation treatment.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Progression-free survival (PFS) — up to approximately 24months
PFS, assessed by the Blinded Independent Central Review (BICR) as per RECIST v1.1
Overall survival (OS) — up to 36 months
the time from randomization to death due to any cause

Trial sites (129)

Facility	City	Region
OPN-Glendale	Arcadia	California
OPN-Los Alamitos	Los Alamitos	California
Southern California Permanente Group	Los Angeles	California
Emad Ibrahim, MD, Inc	Redlands	California
Providence Medical Foundation	Santa Rosa	California
Lutheran Medical Center - Cancer Centers of Colorado	Golden	Colorado
Eastern Connecticut Hematology & Oncology Associates	Norwich	Connecticut
Cancer Specialists of North Florida	Jacksonville	Florida
Mid Florida Hematology and Oncology Center	Orange City	Florida
Advent Health Orlando	Orlando	Florida
Napa Research	Pompano Beach	Florida
Kansas University Mediacal Center	Fairway	Kansas
Pontchartrain Cancer Center	Covington	Louisiana
Tulane University	New Orleans	Louisiana
Health Partners	Bloomington	Minnesota
Renown Health	Reno	Nevada
Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
New York City Health+HospitalsCorporation Elmhurst Hospital Center	Elmhurst	New York
Northwell Health	Queens	New York
Montefiore Medical Center	The Bronx	New York
Cleveland Clinic Mercy Hospital	Canton	Ohio
Gabrail Cancer Center	Canton	Ohio
Tricounty Hematology and Oncology Associates	Massillon	Ohio
Kaiser Permanente Northwest	Portland	Oregon
The Center for Cancer and Blood Disorders	Fort Worth	Texas
The University of Texas MD Anderson Cancer Center	Houston	Texas
Millennium Research & Clinical Development	Houston	Texas
Pro Research Tools, INC DBA Lumi Research	Kingwood	Texas
The University of Texas - Hope Cancer Center	Tyler	Texas
Innova Schar Cancer Insitute	Fairfax	Virginia
Northwest Medical Specialties	Tacoma	Washington
Klinikum Klagenfurt am Worthersee	Klagenfurt	Austria
Klinikum Klagenfurt am Wörthersee	Klagenfurt	Austria
Karl Landsteiner Institut für Lungenforschung und pneumologische Onkologie, c/o Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie	Vienna	Austria
Karl Landsteiner Institute for Lung Research and Pneumological Oncology, c/o Klinik Floridsdorf Department for Inner Medicine und Pneumology	Vienna	Austria
The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
Anhui Chest Hospital	Hefei	Anhui
Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing Municipality
Beijing Cancer Hospital	Beijing	Beijing Municipality
The First Affiliated Hospital of Chongqing Medical	Chongqing	Chongqing Municipality

+ 89 more sites — see the full list on the official registry below.

More Shanghai Henlius Biotech trials in China

A Study to Explore the Reasonable Dosage and Evaluate the Efficacy, Safety and Tolerability of HLX10 and HLX04 with or Without HLX53 in Untreated, Locally Advanced or Metastatic Hepatocellular Carcinoma Patients. Recruiting

A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma Recruiting

Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX29 Compared With HLX11 Starting soon

A Phase I Clinical Study of HLX316 in Participants With Advanced/Metastatic Solid Tumors Recruiting

Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05353257 on ClinicalTrials.gov ↗ ← All trials in China