Phase 3 Study of RRx-001 with Platinum Chemotherapy for Small Cell Lung Cancer

Sponsor: EpicentRx, Inc.

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT05566041

Provider View

This study is testing whether adding RRx-001 to standard platinum chemotherapy is more effective than chemotherapy alone for patients with small cell lung cancer who have already tried other treatments.

Patient Parameters

Program Overview

This global study is exploring if a new drug, RRx-001, combined with standard platinum chemotherapy, can better treat small cell lung cancer (SCLC) in patients who have already undergone at least two previous treatments. SCLC is a very aggressive cancer, often found in the lungs, and is difficult to treat because it quickly becomes resistant to therapies. The study aims to see if RRx-001 can make the cancer more responsive to the initial chemotherapy treatment, potentially improving outcomes for patients.

Description

Small cell lung cancer (SCLC) is a fast-growing cancer that is hard to treat. It often starts in the lungs but can also appear in other parts of the body. SCLC is known for being aggressive and resistant to treatment, which makes it challenging to manage. Typically, patients receive a combination of chemotherapy drugs called a platinum doublet as their first treatment. While this often works initially, the cancer usually becomes resistant, requiring new treatments.

This study, named REPLATINUM, is testing a new approach by adding a drug called RRx-001 to the standard platinum chemotherapy. The goal is to see if RRx-001 can make the cancer more sensitive to the chemotherapy, even after it has become resistant. Patients in the study will be randomly assigned to one of two groups: one group will receive RRx-001 with the platinum doublet, and the other group will receive the platinum doublet alone. If the cancer worsens in the second group, patients can switch to the first group to receive RRx-001 with the chemotherapy.

The study offers hope that RRx-001 might help restore the effectiveness of the initial chemotherapy, potentially improving treatment outcomes for patients with SCLC.

Eligibility Criteria

Inclusion Criteria

  • Aged between 18 and 80 years old.
  • Previously treated with platinum-based chemotherapy.
  • Previously treated with a checkpoint inhibitor, unless not suitable.
  • Have received at least two prior treatments for cancer.
  • Confirmed diagnosis of small cell lung cancer through a biopsy.
  • Able to provide informed consent and follow study procedures.
  • Have measurable cancer as confirmed by imaging scans.
  • Have a performance status score of 0 to 2, indicating good overall health.

Exclusion Criteria

  • Have symptoms of cancer spread to the brain or are unstable neurologically and need increasing doses of steroids.
  • Have another type of cancer, except for certain skin or cervical cancers.
  • Have been treated with any cancer drugs other than steroids for SCLC.
  • Have serious health conditions that could affect participation, such as uncontrolled infections, immune deficiencies, or certain heart conditions.
  • Have had an allergic reaction to platinum-based chemotherapy or had to stop it due to severe side effects.
  • Have uncontrolled fluid buildup around the lungs or heart.
  • Are pregnant or breastfeeding, due to potential risks to the baby.
  • Have an active COVID-19 infection.

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