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Alkylating agents

RRx-001 + Platinum Chemotherapy for Small Cell Lung Cancer (REPLATINUM Trial)

Phase 3
Recruiting
Research Sponsored by EpicentRx, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable disease by RECIST 1.1. Measurable lesions will be confirmed by imaging (CT scan)
Biopsy confirmation of small cell lung cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up estimated up to 12 months
Awards & highlights

REPLATINUM Trial Summary

This trial is testing whether adding RRx-001 to platinum chemotherapy can help treat small cell cancer that has progressed after two other treatments.

Who is the study for?
This trial is for adults aged 18-80 with small cell lung cancer who've had at least two prior treatments, including platinum chemotherapy and a checkpoint inhibitor (unless not suitable). They must have measurable disease confirmed by CT scan, be able to consent and follow the study plan. Exclusions include uncontrolled illnesses, certain infections like Hepatitis B/C or COVID-19, allergic reactions to platinum drugs (except blood toxicity), symptomatic brain metastases, another primary cancer, pregnancy/nursing.Check my eligibility
What is being tested?
The study compares RRx-001 combined with a platinum-based chemo drug using an eLOOP Device against standard treatment of cisplatin/carboplatin plus etoposide in patients who are receiving their third line or later treatment for small cell lung cancer. The goal is to see if adding RRx-001 improves effectiveness.See study design
What are the potential side effects?
Potential side effects may include typical reactions from chemotherapy such as nausea, fatigue, hair loss and increased risk of infection. Specific side effects related to RRx-001 aren't detailed but could align with common chemo-related issues given its use alongside platinum drugs.

REPLATINUM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be measured and tracked using scans.
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My lung cancer was confirmed by a biopsy.
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I have previously been treated with a checkpoint inhibitor, unless it was not suitable for me.
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I have undergone at least 2 previous treatments.
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I am between 18 and 80 years old.
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I can take care of myself and am up and about more than half of the day.
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I have previously received platinum-based chemotherapy.

REPLATINUM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~estimated up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated up to 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival (PFS) and Overall Survival (OS)
Secondary outcome measures
Overall Response Rate (ORR)
Other outcome measures
Disease Control Rate (DCR)
Relative Dose Intensities (RDIs)

REPLATINUM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment1 Intervention
RRx-001 + eLOOP Device 4 mg IV infusion once weekly for 3 weeks Cisplatin/carboplatin plus etoposide (up to 4 cycles): Cisplatin or Carboplatin: Cisplatin initially dosed at 60 mg/m2 on Day 1 every 3 weeks OR Carboplatin initially dosed at an AUC (area under the curve) of 5 on Day 1 every 3 weeks Etoposide to be given per the initial approval by the package insert (USPI FDA) at 100 mg/m2 Days 1-3 every 3 weeks
Group II: Arm 2Active Control1 Intervention
Cisplatin/carboplatin plus etoposide (up to 4 cycles): Cisplatin or Carboplatin: Cisplatin initially dosed at 60 mg/m2 on Day 1 every 3 weeks OR Carboplatin initially dosed at an AUC of 5 on Day 1 every 3 weeks Etoposide to be given per the initial approval by the package insert (USPI FDA) at 100 mg/m2 Days 1-3 every 3 weeks

Find a Location

Who is running the clinical trial?

EpicentRx, Inc.Lead Sponsor
15 Previous Clinical Trials
762 Total Patients Enrolled
Sciclone Pharmaceuticals (China) Co., Ltd.UNKNOWN

Media Library

Cisplatin/Carboplatin (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT05566041 — Phase 3
Small Cell Lung Cancer Research Study Groups: Arm 1, Arm 2
Small Cell Lung Cancer Clinical Trial 2023: Cisplatin/Carboplatin Highlights & Side Effects. Trial Name: NCT05566041 — Phase 3
Cisplatin/Carboplatin (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05566041 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can people with the condition still join the research project?

"According to the most recent update on clinicaltrials.gov, this study is not looking for any new patients at this time. The posting went up on August 1st, 2020 and was edited October 3rd, 2020. There are 312 other trials that are currently accepting participants."

Answered by AI

What are the risks associated with enrolling in Arm 1 of this trial?

"Arm 1 of the clinical trial has received a safety rating of 3. This is based on the fact that it is a Phase 3 study, so while there may not be extensive data supporting efficacy, there are multiple rounds of data affirming its safety."

Answered by AI

Does this experiment only consider geriatric patients?

"This study is only enrolling adults that are under the age of 80."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2022. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05566041.
~146 spots leftby Dec 2025
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