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A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 With a Platinum Doublet or a Platinum Doublet in Small Cell Lung Cancer
Sponsor: EpicentRx, Inc.
Summary
This Global Phase 3 study aims to find out whether RRx-001 + platinum chemotherapy is more effective than platinum chemotherapy alone in 3rd line or beyond small cell cancer.
Official title: REPLATINUM: A Phase 3, Controlled, Open-label, Global Randomized Study of RRx-001 Administered Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond Small Cell Lung Cancer
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
292
Start Date
2022-08-01
Completion Date
2025-12-31
Last Updated
2024-10-31
Healthy Volunteers
No
Conditions
Interventions
RRx-001 + eLOOP Device
RRx-001 is a small molecule anticancer drug which is mixed with patient's own blood using the eLOOP device Drug: Cisplatin/carboplatin plus etoposide Standard of care platinum doublet chemotherapy
Cisplatin/carboplatin plus etoposide
Standard of care platinum doublet chemotherapy
Locations (2)
H. Lee Moffitt Cancer Center & Research Institute, Inc.
Tampa, Florida, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States