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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

NCT05566041 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 292

Last updated 2024-10-31

No results posted yet for this study

Summary

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.

Conditions

  • Carcinoma, Small Cell Lung

Interventions

DRUG

RRx-001 + eLOOP Device

RRx-001 is a small molecule anticancer drug which is mixed with patient's own blood using the eLOOP device Drug: Cisplatin/carboplatin plus etoposide Standard of care platinum doublet chemotherapy

DRUG

Cisplatin/carboplatin plus etoposide

Standard of care platinum doublet chemotherapy

Sponsors & Collaborators

  • Sciclone Pharmaceuticals (China) Co., Ltd.

    collaborator UNKNOWN

  • EpicentRx, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05566041 on ClinicalTrials.gov