RRx-001 Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond in Patients With Small Cell Lung Cancer

Stopped early · Phase 3

Conditions studied: Carcinoma, Small Cell Lung

In brief

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.

Key facts

Study ID

NCT03699956

Run by

EpicentRx, Inc.

People needed

18

Starts

2018-12-24

Expected to finish

2024-03-01

Last updated by the study team

2024-03-26

Who can join

Age: 18 and older, up to 79. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 and < 80 years
• Prior platinum treatment is required
• Prior treatment with a checkpoint inhibitor is required unless contraindicated. Maintenance with a checkpoint inhibitor is NOT required
• Patient must have received at least 2 prior lines of therapy
• Biopsy confirmation of small cell lung cancer
• Capable of providing informed consent and complying with trial procedures
• Measurable disease by RECIST 1.1. Measurable lesions will be confirmed by imaging (CT scan)
• PS 0-1

You may not qualify if…

• Symptomatic central nervous system metastases or neurologically unstable patients that are on increasing steroid dose.
• The presence of another primary malignancy (excluding in situ of the cervix or basal carcinoma of the skin)
• Treatment of SCLC with any antineoplastic agent with the exception of steroids.
• 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.
• 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)
• 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
• Uncontrolled or symptomatic pleural or pericardial effusion
• Pregnant or nursing. There is a potential for congenital abnormalities and for this regimen to harm nursing infants

Where it is running

• Centura Health Research Center — Denver, Colorado, United States
• Mid Florida Hematology and Oncology Center — Orange City, Florida, United States
• AdventHealth Hematology and Oncology — Orlando, Florida, United States
• H. Lee Moffitt Cancer Center & Research Institute, Inc. — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Cotton O'Neil Clinical Research Center.Hematology & Oncology — Topeka, Kansas, United States
• The University of Kansas Cancer Center — Westwood, Kansas, United States
• Norton Cancer Institute, Norton Healthcare Pavilion — Louisville, Kentucky, United States
• University of Maryland Marlene and Stewart Greenbaum Comprehensive Cancer Center — Baltimore, Maryland, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Washington University School of Medicine - Siteman Cancer Center — St Louis, Missouri, United States
• Oncology Hematology West PC dba Nebraska Cancer Specialists — Omaha, Nebraska, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Stephenson Cancer Center — Oklahoma City, Oklahoma, United States
• Tennessee Cancer Specialists — Knoxville, Tennessee, United States
• Millennium Oncology — Houston, Texas, United States
• HOPE Cancer Center of East Texas — Tyler, Texas, United States
• Utah Cancer Specialist — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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