ClinicalTrials.gov record
Active, not recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT05353257

Public ClinicalTrials.gov record NCT05353257. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Apr 22, 2026, 7:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer

Study identification

NCT ID
NCT05353257
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
Shanghai Henlius Biotech
Industry
Enrollment
511 participants

Conditions and interventions

Interventions

  • HLX10 Drug
  • Placebo Drug
  • Prophylactic Cranial Irradiation (PCI) Radiation
  • Thoracic radiotherapy Radiation
  • carboplatin/cisplatin-etoposide Drug

Drug · Radiation

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 16, 2022
Primary completion
Jun 29, 2026
Completion
May 29, 2028
Last update posted
Jan 12, 2026

2022 – 2028

United States locations

U.S. sites
31
U.S. states
15
U.S. cities
29
Facility City State ZIP Site status
OPN-Glendale Arcadia California 91007
OPN-Los Alamitos Los Alamitos California 90720
Southern California Permanente Group Los Angeles California 90034
Emad Ibrahim, MD, Inc Redlands California 92373
Providence Medical Foundation Santa Rosa California 95403
Lutheran Medical Center - Cancer Centers of Colorado Golden Colorado 80401
Eastern Connecticut Hematology & Oncology Associates Norwich Connecticut 06360
Cancer Specialists of North Florida Jacksonville Florida 32257
Mid Florida Hematology and Oncology Center Orange City Florida 32763
Advent Health Orlando Orlando Florida 32804
Napa Research Pompano Beach Florida 33064
Kansas University Mediacal Center Fairway Kansas 66205
Pontchartrain Cancer Center Covington Louisiana 70433
Tulane University New Orleans Louisiana 70112
Health Partners Bloomington Minnesota 55425
Renown Health Reno Nevada 89502
Dartmouth Hitchcock Medical Center Lebanon New Hampshire 03756
New York City Health+HospitalsCorporation Elmhurst Hospital Center Elmhurst New York 11373
Northwell Health Queens New York 11040
Montefiore Medical Center The Bronx New York 10467
Cleveland Clinic Mercy Hospital Canton Ohio 44708
Gabrail Cancer Center Canton Ohio 44718
Tricounty Hematology and Oncology Associates Massillon Ohio 44646
Kaiser Permanente Northwest Portland Oregon 97229
The Center for Cancer and Blood Disorders Fort Worth Texas 76104
The University of Texas MD Anderson Cancer Center Houston Texas 77030
Millennium Research & Clinical Development Houston Texas 77090
Pro Research Tools, INC DBA Lumi Research Kingwood Texas 77339
The University of Texas - Hope Cancer Center Tyler Texas 75701
Innova Schar Cancer Insitute Fairfax Virginia 22031
Northwest Medical Specialties Tacoma Washington 98405

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 98 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05353257, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jan 12, 2026 · Synced Apr 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05353257 live on ClinicalTrials.gov.

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