What side effects are associated with this type of intervention?

The most common treatments for Small Cell Lung Cancer (SCLC) include platinum-based chemotherapies such as cisplatin and carboplatin, often combined with etoposide or irinotecan. These treatments can cause side effects like nausea, vomiting, hair loss, fatigue, and increased risk of infection due to lowered white blood cell counts. Additionally, platinum compounds can lead to nephrotoxicity (kidney damage) and ototoxicity (hearing loss). Immunotherapy, which is sometimes used in combination with chemotherapy, can cause immune-related side effects such as colitis, pneumonitis, and dermatitis. Treatments like RRx-001, which modulate the tumor microenvironment and induce oxidative stress, may also lead to oxidative damage in normal tissues, potentially causing inflammation and tissue injury.

What prior FDA approvals exist?

FDA-approved treatments for Small Cell Lung Cancer (SCLC) include chemotherapeutic agents such as etoposide and platinum-based drugs (cisplatin or carboplatin), often used in combination. Additionally, immune checkpoint inhibitors like atezolizumab (anti-PD-L1) have been approved for extensive-stage SCLC in combination with chemotherapy. These treatments aim to enhance the immune response against cancer cells and improve survival rates. While specific drugs that modulate the tumor microenvironment, inhibit DNA repair, and induce oxidative stress like RRx-001 are not explicitly mentioned, the combination of chemotherapy and immunotherapy represents a significant advancement in the treatment of SCLC.

What other types of research exist?

Promising novel alternatives to RRx-001 for Small Cell Lung Cancer patients include: 1) Motexafin gadolinium, a radiation sensitizer that enhances the therapeutic index of whole-brain radiotherapy (WBRT) for NSCLC brain metastases by increasing oxidative stress. 2) Xanthatin, which inhibits NSCLC proliferation by disrupting intracellular redox balance, potentially applicable to SCLC. 3) Apatinib and bevacizumab, VEGF-directed therapies that, when combined with cisplatin, have shown efficacy in prolonging survival and reducing tumor burden in NSCLC, which may be relevant for SCLC treatment.

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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

Must not have

Uncontrolled or symptomatic pleural or pericardial effusion

Symptomatic central nervous system metastases or neurologically unstable patients that are on increasing steroid dose

Timeline

Screening 3 weeks

Treatment Varies

Follow Up estimated up to 12 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing a new treatment called RRx-001 combined with standard chemotherapy on patients with small cell cancer who have not responded to previous treatments. The goal is to see if this combination works better than chemotherapy alone by making the cancer cells more sensitive to the treatment. RRx-001 is an experimental agent designed to help cancer cells respond better to treatment.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have fluid buildup in my chest or heart area that is causing symptoms.

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I have brain metastases causing symptoms or need more steroids to manage them.

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I had an allergic reaction or had to stop a platinum-based treatment due to side effects (not including blood-related issues).

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I do not have any major health issues that would stop me from participating in the study.

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I currently have or recently had COVID-19.

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I have another type of cancer besides skin cancer or cervical cancer in situ.

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I have been treated for small cell lung cancer, but not with steroids.

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ estimated up to 12 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression Free Survival (PFS) and Overall Survival (OS)

Secondary study objectives

Overall Response Rate (ORR)

Other study objectives

Disease Control Rate (DCR)

Relative Dose Intensities (RDIs)

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Small Cell Lung Cancer (SCLC) include chemotherapy, immunotherapy, and emerging agents like RRx-001. Chemotherapy agents such as etoposide and platinum compounds (cisplatin or carboplatin) damage the DNA of cancer cells, preventing their replication. Immunotherapy, including PD-1/PD-L1 inhibitors, boosts the immune system's ability to target and destroy cancer cells. RRx-001, currently under study, modulates the tumor microenvironment, inhibits DNA repair, and induces oxidative stress, making cancer cells more vulnerable to treatment. These mechanisms are vital for SCLC patients due to the aggressive nature of the disease, necessitating treatments that can effectively target and eliminate cancer cells while overcoming resistance.