Study on Irinotecan and Cirtuvivint for Treating Small Cell Lung Cancer (SLICK Trial)

Sponsor: Washington University School of Medicine

Sponsor score: 40

ClinicalTrials ID:NCT07155200

Provider View

This clinical trial is exploring a new treatment approach for small cell lung cancer (SCLC) that has returned after initial chemotherapy. The study is testing whether adding a new drug, cirtuvivint, to the chemotherapy drug irinotecan can improve treatment outcomes for patients.

Patient Parameters

Program Overview

Small cell lung cancer (SCLC) often responds well to initial chemotherapy, but it usually comes back. This study is testing a new treatment that combines the chemotherapy drug irinotecan with a new drug called cirtuvivint. Cirtuvivint works by targeting specific proteins in cancer cells, which may help make the cancer more sensitive to chemotherapy. The goal is to see if this combination can help control the cancer better and for longer periods in patients whose cancer has returned after initial treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of small cell lung cancer that has come back after at least one round of platinum-based chemotherapy.
  • Have measurable cancer according to specific medical criteria.
  • Be at least 18 years old.
  • Be in relatively good health, with a performance status score of 2 or less, meaning you are able to carry out light work or are fully active.
  • Have adequate blood cell counts and organ function, including:
    • Neutrophil count of at least 1.0 K/cumm.
    • Platelet count of at least 100 K/cumm.
    • Total bilirubin level within 1.5 times the normal limit.
    • Liver enzymes (AST/ALT) within 2.5 times the normal limit, or 5 times if you have liver metastases.
    • Kidney function with creatinine clearance over 35 mL/min.
  • Agree to use effective contraception during the study and for 31 weeks after treatment if you or your partner could become pregnant.
  • Be able to understand and sign a consent form, or have a representative do so on your behalf.

Exclusion Criteria

  • Have another type of cancer that could interfere with the study treatment.
  • Have had a bad reaction to irinotecan in the past.
  • Be currently taking other experimental drugs.
  • Have untreated or symptomatic brain metastases, unless they have been treated and are stable.
  • Have allergies to similar drugs used in the study.
  • Have a condition causing diarrhea that requires treatment.
  • Have had major surgery within the last 28 days.
  • Have significant liver disease or unresolved side effects from previous treatments.
  • Be pregnant or breastfeeding.
  • Have HIV, hepatitis B, or hepatitis C infections that are not well-controlled.
  • Have certain eye conditions that could be affected by the treatment.
  • Be taking medications that strongly affect liver enzymes within 10 days before starting the study.
  • Have a heart condition that affects the QT interval on an ECG, unless discussed with the study doctor.

Locations

FACILITYZIPCITYSTATE
Washington University School of Medicine63110St LouisMissouri

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