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 | Active Not Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: EpicentRx
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

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

  To compare the co-primary efficacy endpoints comprising progression free survival (PFS) and overall survival (OS). PFS is defined as the time from randomization until disease progression or all-cause mortality between the two arms. Disease progression is assessed by the blinded independent central review (BICR) via RECIST 1.1, and is the basis for the principal definition of PFS. OS is defined as the time from randomization to all-cause mortality

  Estimated up to 12 Months

Secondary Outcomes (1)

• Overall Response Rate (ORR)

  Estimated up to 12 Months

Other Outcomes (2)

• Disease Control Rate (DCR)

  Estimated up to 12 Months

• Relative Dose Intensities (RDIs)

  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): 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

Drug: RRx-001 + eLOOP Device

Arm 2

ACTIVE COMPARATOR

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

Drug: Cisplatin/carboplatin plus etoposide

Interventions

RRx-001 + eLOOP Device DRUG

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

Arm 1

Cisplatin/carboplatin plus etoposide DRUG

Standard of care platinum doublet chemotherapy

Arm 2

Eligibility Criteria

• Age: 18 Years - 80 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.
• 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)
• Performance Status (ECOG) 0-2

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
• Virologic, serologic, or clinical evidence of active SARS-CoV-2 infection

Sponsors & Collaborators

• EpicentRx, Inc.: lead
• Sciclone Pharmaceuticals (China) Co., Ltd.: collaborator

Study Sites (2)

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

Tampa, Florida, 33612, United States

Location

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

RRx-001; Cisplatin; Carboplatin; Etoposide

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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 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: September 30, 2022
• First Posted: October 4, 2022
• Study Start: August 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)