Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05468489 · ClinicalTrials.gov registry record · Phase 3
To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC
A Phase 3 study of Extensive-stage Small-cell Lung Cancer, sponsored by Shanghai Henlius Biotech.
- Active
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT05468489: Active Phase 3 study of Extensive-stage Small-cell Lung Cancer, sponsored by Shanghai Henlius Biotech.
NCT05468489 is a Phase 3 study of Extensive-stage Small-cell Lung Cancer that is active but no longer recruiting, run by Shanghai Henlius Biotech. The registered enrollment target is 200 participants, above the 168-participant average among 25 other Extensive-stage Small-cell Lung Cancer trials with a reported enrollment target (19% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05468489, a Phase 3 study of Extensive-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
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: * Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide) * Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
Primary Outcome
Overall assessment
Conditions Studied
Interventions
- DRUG Serplulimab + chemotherapy (carboplatin-etoposide)
- DRUG Atezolizumab + chemotherapy (carboplatin-etoposide)
Study Locations (20)
Florida
- Advanced Cancer Treatment Centers - Brooksville
- Cancer Specialists North Florida - Jacksonville
- Mount Sinai Comprehensive Cancer Center - Miami
- Florida Cancer Affiliates- (Ocala Oncology - Main) - Ocala
- Mid Florida Hematology and Oncology Center - Orange City
- BRCR Global - Plantation
- Napa Research - Pompano Beach
California
- Compassionate Care Research Group - Fountain Valley
- Providence Medical Foundation - Fullerton
- Los Angeles Cancer Network - Glendale
- OPN - Oncology Physician Network - Los Alamitos
- Kaiser Permanente Research (Southern California) - Los Angeles
- UC Davis - Sacramento
Colorado
- UCHealth Memorial Hospital North - Colorado Springs
- Banner MD Anderson Cancer Center (BMDACC) - Greeley
- MD Anderson- North Colorado Medical Center - Greeley
Arizona
- City of Hope - Phoenix - Goodyear
- Arizona Clinical Research Center (ACRC) - Tucson
Alabama
- Alabama Oncology - Birmingham
Arkansas
- Highlands Oncology Group - Springdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-11-18 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 3 |
What the registry record for NCT05468489 still lists
NCT05468489 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, above the 168-participant average among 25 other Extensive-stage Small-cell Lung Cancer trials with a reported enrollment target (19% higher).
The record links to 1 condition, with Extensive-stage Small-cell Lung Cancer appearing as the primary indexed condition, and to 2 interventions - of which Serplulimab + chemotherapy (carboplatin-etoposide) is the first listed.
NCT05468489 names 20 study sites across 6 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05468489 about?
NCT05468489 is a clinical study titled "To Evaluate Efficacy and Safety of Serplulimab + Chemotherapy (Carboplatin- Etoposide) in US Patients With ES-SCLC". This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC. Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows: * Arm A (Serplulimab)...
What is the current status of trial NCT05468489?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2022-11-18. Estimated completion is 2027-12-31.
What conditions does trial NCT05468489 study?
This clinical trial studies the following conditions: Extensive-stage Small-cell Lung Cancer.
What interventions are being tested in trial NCT05468489?
The interventions under investigation include: Serplulimab + chemotherapy (carboplatin-etoposide) (DRUG), Atezolizumab + chemotherapy (carboplatin-etoposide) (DRUG).
Who is sponsoring clinical trial NCT05468489?
This trial is sponsored by Shanghai Henlius Biotech, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05468489 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Extensive-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.
Where NCT05468489's enrollment target sits among peer trials
200 8th of 25 higher than 18 of 25 other Extensive-stage Small-cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Extensive-stage Small-cell Lung Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer
RECRUITING · Phase 3
-
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
RECRUITING · Phase 3
-
A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
RECRUITING · Phase 3
-
Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and Durvalumab
ACTIVE NOT RECRUITING · Phase 3
-
Durvalumab and Ablative Radiation in Small Cell Lung Cancer (DARES)
RECRUITING · Phase 2
-
A Study of Valemetostat in Combination With Atezolizumab in People With Lung Cancer
RECRUITING · Phase 1
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
- NCT00107289 · 200 participants · Phase 2
Iodine I 131 Metaiodobenzylguanidine in Treating Patients With Recurrent, Progressive, or Refractory Neuroblastoma or Malignant Pheochromocytoma or Paraganglioma
- NCT00109174 · 200 participants · NA
MRS Measurement of Glutamate and GABA Metabolism in Brain
- NCT00177268 · 200 participants
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
- NCT00493688 · 200 participants
A Study to Determine Whether Perioperative Energy Dynamics Correlates With Postoperative Outcomes
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