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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 Oct 20, 2026, 5:43 PM 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

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

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

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

Study timeline

Start date
May 17, 2022 (Actual)
Primary completion
Jun 30, 2026 (Estimated)
Completion
May 30, 2028 (Estimated)
Last update posted
Jan 13, 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 13, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05353257 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →