RRx-001 Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond in Patients With Small Cell Lung Cancer
This 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.
Checked against the public recordLast updated Mar 26, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 3
- Sponsor
- EpicentRx, Inc.
- Interventions being studied
- Combination Product: RRx-001 + eLOOP Device; Drug: Cisplatin/carboplatin plus etoposide
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Inclusion Criteria: 1. Age ≥ 18 and \< 80 years 2. Prior platinum treatment is required 3. Prior treatment with a checkpoint inhibitor is required unless contraindicated. Maintenance with a checkpoint inhibitor is NOT required 4. Patient must have received at least 2 prior lines of therapy 5. Biopsy confirmation of small cell lung cancer 6. Capable of providing informed consent and complying with trial procedures 7. Measurable disease by RECIST 1.1. Measurable lesions will be confirmed by imaging (CT scan) 8. PS 0-1 Exclusion Criteria: 1. Symptomatic central nervous system metastases or neurologically unstable patients that are on increasing steroid dose. 2. The presence of another primary malignancy (excluding in situ of the cervix or basal carcinoma of the skin) 3. Treatment of SCLC with any antineoplastic agent with the exception of steroids. 4. Patients with clinically significant illnesses which would compromise participation in the study, including, but not limited to active or uncontrolled infection, immune deficiencies, Hepatitis B, Hepatitis C, uncontrolled diabetes, uncontrolled hypertension, certain heart conditions, or mental illness/social situations that would limit compliance with study requirements. 5. History of an allergic reaction to previously received platinum-based regimen, or history of having to discontinue previously received platinum-based regimen secondary to toxicity (excluding hematologic toxicity) 6. Any clinical laboratory findings, which give reasonable suspicion of a disease or condition that contraindicates the use of any study medication or renders the patient at high risk from treatment 7. Uncontrolled or symptomatic pleural or pericardial effusion 8. Pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Centura Health Research CenterDenver, Colorado
- Mid Florida Hematology and Oncology CenterOrange City, Florida
- AdventHealth Hematology and OncologyOrlando, Florida
- H. Lee Moffitt Cancer Center & Research Institute, Inc.Tampa, Florida
- Rush University Medical CenterChicago, Illinois
- Cotton O'Neil Clinical Research Center.Hematology & OncologyTopeka, Kansas
- The University of Kansas Cancer CenterWestwood, Kansas
- Norton Cancer Institute, Norton Healthcare PavilionLouisville, Kentucky
- University of Maryland Marlene and Stewart Greenbaum Comprehensive Cancer CenterBaltimore, Maryland
- University of Mississippi Medical CenterJackson, Mississippi
- Washington University School of Medicine - Siteman Cancer CenterSt Louis, Missouri
- Oncology Hematology West PC dba Nebraska Cancer SpecialistsOmaha, Nebraska
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 26, 2024. Always confirm current availability with the study team.