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

Running, not enrolling · Phase 3

Conditions studied: Carcinoma, Small Cell Lung

In brief

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.

Key facts

Study ID: NCT05566041
Run by: EpicentRx, Inc.
People needed: 292
Starts: 2022-08-01
Expected to finish: 2025-12-31
Last updated by the study team: 2024-10-31

Who can join

Age: 18 and older, up to 80. 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.
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)
Performance Status (ECOG) 0-2

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
Virologic, serologic, or clinical evidence of active SARS-CoV-2 infection

Where it is running

H. Lee Moffitt Cancer Center & Research Institute, Inc. — Tampa, Florida, United States
The University of Kansas Cancer Center — Westwood, Kansas, United States

Full record on ClinicalTrials.gov

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