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NCT06095583 · ClinicalTrials.gov registry record · Phase 3
Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)
A Phase 3 study of Limited-stage Small Cell Lung Cancer (LS-SCLC), sponsored by Shanghai Junshi Bioscience Co..
- Recruiting
- Registry status
- Phase 3
- Development phase
- 756
- Enrollment target
- 20
- Study locations
NCT06095583: Recruiting Phase 3 study of Limited-stage Small Cell Lung Cancer (LS-SCLC), sponsored by Shanghai Junshi Bioscience Co..
NCT06095583 is a Phase 3 study of Limited-stage Small Cell Lung Cancer (LS-SCLC) that is actively recruiting participants, run by Shanghai Junshi Bioscience Co.. The registered enrollment target is 756 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06095583, a Phase 3 study of Limited-stage Small Cell Lung Cancer (LS-SCLC), is actively recruiting participants, sponsored by Shanghai Junshi Bioscience Co..
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 756 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer without disease progression following chemoradiotherapy. Tifcemalimab is a monoclonal antibody against B and T lymphocyte attenuator (BTLA). Toripalimab is a monoclonal antibody against programmed death protein-1 (PD-1). Neither drug is approved for treatment of This combination regimen is investigational in limited stage-small cell lung cancer in any country.
Conditions Studied
Interventions
- DRUG Tifcemalimab injection
- DRUG toripalimab injection
- DRUG Placebo for Tifcemalimab
- DRUG Placebo for toripalimab
Study Locations (20)
California
- SCRI Nashville - Davis
- Zangmeister Cancer Center (Columbus, OH) - Los Angeles
- Los Angeles Hematology Oncology - Los Angeles
- University of Southern California Norris Comprehensive Cancer - Los Angeles
Florida
- Florida Cancer Specialists Pan Handle - Fort Myers
- Florida Cancer Specialists South - Fort Myers
- USA029 University of Miami Sylvester Comprehensive Cancer Center 1550 NW 10th Avenue 33173 Miami FL Ikpeazu Chukwuemeka N - Miami
- Mid-Florida Hematology Oncology - Orange City
Michigan
- Karmanos Cancer Center - Detroit
- Henry Ford Health System - Detroit
- Cancer and Hematology Centers of Western Michigan - Grand Rapids
Arizona
- Banner MD Anderson Cancer Center - Goodyear
- Banner University Medical Center - Tucson
Arkansas
- Genesis Cancer and Blood Institute (Hot Springs, AR) - Hot Springs
Georgia
- Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital - Marietta
Kentucky
- Norton Cancer Institute, Downtown, Multidisciplinary Clinic - Louisville
Maryland
- American Oncology Partners of Maryland, PA - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 756 participants |
| Start Date | 2023-11-15 |
| Est. Completion | 2029-07-31 |
| Phase | Phase 3 |
What NCT06095583 shows while recruiting
NCT06095583 is an interventional study that assigns participants to a tested intervention. The registered 756 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 1 condition, with Limited-stage Small Cell Lung Cancer (LS-SCLC) appearing as the primary indexed condition, and to 4 interventions - of which Tifcemalimab injection is the first listed.
NCT06095583 names 20 study sites across 11 states, led by California, Florida, Michigan.
Frequently Asked Questions
What is clinical trial NCT06095583 about?
NCT06095583 is a clinical study titled "Phase 3 Study of Toripalimab Alone or in Combination With Tifcemalimab as Consolidation Therapy in Patients With Limited-stage Small Cell Lung Cancer (LS-SCLC)". The Study is a Phase 3, randomized, three-arm, double-blind, placebo-controlled, multi-regional clinical research study to evaluate the safety and efficacy use of toripalimab alone or in combination with tifcemalimab as consolidation therapy in patients with limited-stage small cell lung cancer with...
What is the current status of trial NCT06095583?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 756 participants. The study started on 2023-11-15. Estimated completion is 2029-07-31.
What conditions does trial NCT06095583 study?
This clinical trial studies the following conditions: Limited-stage Small Cell Lung Cancer (LS-SCLC).
What interventions are being tested in trial NCT06095583?
The interventions under investigation include: Tifcemalimab injection (DRUG), toripalimab injection (DRUG), Placebo for Tifcemalimab (DRUG), Placebo for toripalimab (DRUG).
Who is sponsoring clinical trial NCT06095583?
This trial is sponsored by Shanghai Junshi Bioscience Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06095583 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06095583's enrollment target sits among peer trials
756 457th of 2000 higher than 1,543 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
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