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

Trial details

Who runs it

EpicentRx, Inc.

Trial code

NCT03699956

Record updated

26 March 2024

Original description

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.Read full original descriptionShow less

A Phase 3, Controlled, Open-label, Randomized Study of RRx-001 Administered Sequentially With a Platinum Doublet or a Platinum Doublet in Third-Line or Beyond 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.

Inclusion: 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.

Exclusion: Symptomatic central nervous system metastases or neurologically unstable patients that are on increasing steroid dose; Treatment of SCLC with any antineoplastic agent with the exception of steroids; 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); The presence of another primary malignancy (excluding in situ of the cervix or basal carcinoma of the skin); 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; 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.

ClinicalTrials.gov NCT03699956