TerminatedPhase 3NCT03699956
Official study title

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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedRRx-001 + eLOOP Device and Cisplatin/carboplatin plus etoposide

The study team can explain what participation involves.

Who it may be forSmall cell lung cancer (SCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 26, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 3

Interventional

Where is it offered?18 U.S. locations

Locations may change over time.

Who runs it?EpicentRx, Inc.

Study sponsor

01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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.

04
Study sites

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.

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