Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC: PRECISE Trial
Status:
Active, not recruiting
Trial end date:
2024-02-14
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess whether treatment with the study drug
tetrahydrouridine-decitabine (THU-Dec) in combination with nivolumab is more effective than
treatment with nivolumab alone in patients with NSCLC.
Decitabine is an investigational (experimental) drug that works by depleting DNA
methyltransferase 1 (DNMT1). DNMT1 is an enzyme, or protein that causes chemical changes,
often increased in cancer. Blocking DNMT1 has been shown to reduce tumor formation.
Decitabine is experimental in this study because it is not approved by the Food and Drug
Administration (FDA) for patients with lung cancer. Decitabine is approved by the FDA for
treating patients with a blood disease called myelodysplastic syndrome (MDS, a condition
where the bone marrow does not make blood cells normally).
THU is an investigational (experimental) drug that works by blocking an enzyme that breaks
down decitabine. This enzyme is highly expressed in solid tissues of the body, limiting the
distribution of decitabine into these tissues, including solid cancer tissues. So, THU will
increase the time cells are exposed to decitabine. The idea is that THU will also increase
the time that the lung cancer cells are exposed to decitabine. THU is experimental because it
is also not approved by the FDA, although it has been extensively used in clinical trials,
including several cancer trials.