Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 3 study of Limited Stage Small Cell Lung Cancer, sponsored by Shanghai Henlius Biotech.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
PFS, assessed by the Blinded Independent Central Review (BICR) as per RECIST v1.1
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 |
What the registry record for NCT05353257 still lists
NCT05353257 is an interventional study that assigns participants to a tested intervention. The registered 511 participants enrollment target is mid-sized for trials with a published cap, above the 192-participant average among 4 other Limited Stage Small Cell Lung Cancer trials with a reported enrollment target (166% higher).
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 names 20 study sites across 10 states, led by 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.
Learn More About Clinical Trials
Similar trials for Limited Stage Small Cell Lung Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)
RECRUITING · Phase 3
-
BMS-986489 (Atigotatug + Nivolumab) vs Durvalumab in Limited-stage Small-cell Lung Cancer (TIGOS-LS)
RECRUITING · Phase 2
-
Tirapazamine Combined With Chemo and RT in Limited-Stage Small Cell Lung Cancer
COMPLETED · Phase 2
-
Dasatinib in Treating Patients With Relapsed Small Cell Lung Cancer
COMPLETED · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05005403 · 512 participants · Phase 1
Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer (NSCLC), Head and Neck Squamous Cell Carcinoma (HNSCC) and Other Solid Tumors, Receiving Intravenous (IV) Infusion of Azirkitug (ABBV-514) Alone or in Combination With Budigalimab or Bevacizumab
- NCT05337410 · 512 participants · NA
YES: Innovative Discussion for Engagement, Achievement, and Service
- NCT06096259 · 512 participants · Phase 2
Preventing Injured Knees From osteoArthritis: Severity Outcomes
- NCT03922542 · 510 participants · Phase 2
Comparison of Standard vs. Accelerated Corneal Crosslinking
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI