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NCT05353257 · ClinicalTrials.gov registry record · Phase 3
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
A Phase 3 study of Limited Stage Small Cell Lung Cancer, sponsored by Shanghai Henlius Biotech.
- Active
- Registry status
- Phase 3
- Development phase
- 511
- Enrollment target
- 20
- Study locations
NCT05353257 is a Phase 3 study of Limited Stage Small Cell Lung Cancer that is active but no longer recruiting, run by Shanghai Henlius Biotech. The registered enrollment target is 511 participants, above the 192-participant average among 4 other Limited Stage Small Cell Lung Cancer trials with a reported enrollment target (166% higher). The trial reports 20 study locations across 10 states.
The verdict
NCT05353257, a Phase 3 study of Limited Stage Small Cell Lung Cancer, is active but no longer recruiting, sponsored by Shanghai Henlius Biotech.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 511 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG HLX10
- DRUG carboplatin/cisplatin-etoposide
- RADIATION Thoracic radiotherapy
- RADIATION Prophylactic Cranial Irradiation (PCI)
Study Locations (20)
California
- OPN-Glendale - Arcadia
- OPN-Los Alamitos - Los Alamitos
- Southern California Permanente Group - Los Angeles
- Emad Ibrahim, MD, Inc - Redlands
- Providence Medical Foundation - Santa Rosa
Florida
- Cancer Specialists of North Florida - Jacksonville
- Mid Florida Hematology and Oncology Center - Orange City
- Advent Health Orlando - Orlando
- Napa Research - Pompano Beach
New York
- New York City Health+HospitalsCorporation Elmhurst Hospital Center - Elmhurst
- Northwell Health - Queens
- Montefiore Medical Center - The Bronx
Louisiana
- Pontchartrain Cancer Center - Covington
- Tulane University - New Orleans
Colorado
- Lutheran Medical Center - Cancer Centers of Colorado - Golden
Connecticut
- Eastern Connecticut Hematology & Oncology Associates - Norwich
Kansas
- Kansas University Mediacal Center - Fairway
Minnesota
- Health Partners - Bloomington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2022-05-17 |
| Est. Completion | 2028-05-30 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05353257
The ClinicalTrials.gov registry entry for NCT05353257 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 511 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 192-participant average among 4 other Limited Stage Small Cell Lung Cancer trials with a reported enrollment target (166% higher). The listed sponsor is Shanghai Henlius Biotech, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Limited Stage Small Cell Lung Cancer appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT05353257 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Florida, New York.
Frequently Asked Questions
What is clinical trial NCT05353257 about?
NCT05353257 is a clinical study titled "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". 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.
What is the current status of trial NCT05353257?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 511 participants. The study started on 2022-05-17. Estimated completion is 2028-05-30.
What conditions does trial NCT05353257 study?
This clinical trial studies the following conditions: Limited Stage Small Cell Lung Cancer.
What interventions are being tested in trial NCT05353257?
The interventions under investigation include: Placebo (DRUG), HLX10 (DRUG), carboplatin/cisplatin-etoposide (DRUG), Thoracic radiotherapy (RADIATION), Prophylactic Cranial Irradiation (PCI) (RADIATION).
Who is sponsoring clinical trial NCT05353257?
This trial is sponsored by Shanghai Henlius Biotech, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05353257 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.