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

NCT03699956 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: RRx001-33
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 18

Brief Summary

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.

Conditions

Carcinoma, Small Cell Lung

Keywords

RRx-001; Lung Cancer; Lung Neoplasms; Phase 3; Immunotherapy; Small Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  The time from the date of randomization to disease progression (radiologic and/or symptomatic per RECIST 1.1) or death from any cause

  Estimated up to 12 Months

Secondary Outcomes (2)

• Overall Survival

  Estimated up to 12 Months

• Overall response rate

  Estimated up to 12 Months

Study Arms (2)

Arm 1

EXPERIMENTAL

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

Combination Product: RRx-001 + eLOOP Device; Drug: Cisplatin/carboplatin plus etoposide

Arm 2

ACTIVE COMPARATOR

Cisplatin/carboplatin plus etoposide (up to 4 cycles): 1. Cisplatin or Carboplatin: 1. Cisplatin initially dosed at 60 mg/m2 on Day 1 every 3 weeks OR 2. Carboplatin initially dosed at an AUC of 5 on Day 1 every 3 weeks 2. Etoposide to be given per the initial approval by the package insert (USPI FDA) at 100 mg/m2 Days 1-3 every 3 weeks

Drug: Cisplatin/carboplatin plus etoposide

Interventions

RRx-001 + eLOOP Device COMBINATION_PRODUCT

RRx-001 is a small molecule anticancer drug which is mixed with patient's own blood using the eLOOP device

Arm 1

Cisplatin/carboplatin plus etoposide DRUG

Standard of care platinum doublet chemotherapy

Arm 1; Arm 2

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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

Sponsors & Collaborators

• EpicentRx, Inc.: lead

Study Sites (18)

Centura Health Research Center

Denver, Colorado, 80210, United States

Location

Mid Florida Hematology and Oncology Center

Orange City, Florida, 32763, United States

Location

AdventHealth Hematology and Oncology

Orlando, Florida, 32804, United States

Location

H. Lee Moffitt Cancer Center & Research Institute, Inc.

Tampa, Florida, 33612, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Cotton O'Neil Clinical Research Center.Hematology & Oncology

Topeka, Kansas, 66606, United States

Location

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

Norton Cancer Institute, Norton Healthcare Pavilion

Louisville, Kentucky, 40202, United States

Location

University of Maryland Marlene and Stewart Greenbaum Comprehensive Cancer Center

Baltimore, Maryland, 21201, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39213, United States

Location

Washington University School of Medicine - Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Oncology Hematology West PC dba Nebraska Cancer Specialists

Omaha, Nebraska, 68124, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Stephenson Cancer Center

Oklahoma City, Oklahoma, 73104, United States

Location

Tennessee Cancer Specialists

Knoxville, Tennessee, 37909, United States

Location

Millennium Oncology

Houston, Texas, 77090, United States

Location

HOPE Cancer Center of East Texas

Tyler, Texas, 75701, United States

Location

Utah Cancer Specialist

Salt Lake City, Utah, 84106, United States

Location

Related Publications (2)

• Jayabalan N, Oronsky B, Cabrales P, Reid T, Caroen S, Johnson AM, Birch NA, O'Sullivan JD, Gordon R. A Review of RRx-001: A Late-Stage Multi-Indication Inhibitor of NLRP3 Activation and Chronic Inflammation. Drugs. 2023 Apr;83(5):389-402. doi: 10.1007/s40265-023-01838-z. Epub 2023 Mar 15.

  PMID: 36920652 DERIVED

• Oronsky B, Reid TR, Larson C, Caroen S, Quinn M, Burbano E, Varner G, Thilagar B, Brown B, Coyle A, Ferry L, Abrouk N, Oronsky A, Scribner CL, Carter CA. REPLATINUM Phase III randomized study: RRx-001 + platinum doublet versus platinum doublet in third-line small cell lung cancer. Future Oncol. 2019 Oct;15(30):3427-3433. doi: 10.2217/fon-2019-0317. Epub 2019 Sep 11.

  PMID: 31509028 DERIVED

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Lung Neoplasms; Carcinoma, Small Cell

Interventions

RRx-001; Cisplatin; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates

Study Officials

• Bryan Oronsky, MD, PhD

  EpicentRx, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: In this study, patients will be randomized to 1 of 2 groups or arms. Patients in Arm 1 will receive the study drug, RRx-001, once a week for 3 weeks followed by up to 4 cycles of platinum doublet (platinum plus etoposide) chemotherapy. Patients with stable disease or better will go on to the Platinum Stacking Phase and will receive RRx-001 once a week for 2 weeks followed by 2 cycles of single agent platinum chemotherapy in a repeating pattern until such time as their cancer gets worse.. Patients in Arm 2 will receive the standard of care platinum doublet (platinum plus etoposide) chemotherapy for up to 4 cycles. . Patients in arm 2 whose cancer gets worse (as determined by imaging scans), may "cross-over" to the Platinum Stacking Phase of Arm 1 (see study schema below).

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 9, 2018
• Study Start: December 24, 2018
• Primary Completion: August 11, 2022
• Study Completion: March 1, 2024
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (18)