Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02664181 · ClinicalTrials.gov registry record · Phase 2
Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC: PRECISE Trial
A Phase 2 study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT02664181: Completed Phase 2 study, sponsored by Case Comprehensive Cancer Center.
NCT02664181 is a Phase 2 study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02664181, a Phase 2 study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study 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.
Primary Outcome
Overall response rate (ORR) is defined as the proportion of all randomized subjects whose best overall response (BOR) from baseline is either a complete response (CR) or partial response (PR) per RECIST 1.1 criteria. BOR is determined by the best response designation recorded between the date of randomization and the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first. For subjects without documented progression or subsequent anticance
Interventions
- DRUG Nivolumab
- DRUG Tetrahydrouridine
- DRUG oral decitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2017-06-06 |
| Est. Completion | 2024-05-19 |
| Phase | Phase 2 |
What the finished NCT02664181 record still lists
NCT02664181 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT02664181 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02664181 about?
NCT02664181 is a clinical study titled "Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC: PRECISE Trial". 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 depletin...
What is the current status of trial NCT02664181?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2017-06-06. Estimated completion is 2024-05-19.
What interventions are being tested in trial NCT02664181?
The interventions under investigation include: Nivolumab (DRUG), Tetrahydrouridine (DRUG), oral decitabine (DRUG).
Who is sponsoring clinical trial NCT02664181?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02664181's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03125655 · 13 participants
Regulation of Inflammatory Genes in Psoriasis
- NCT03774446 · 13 participants · Phase 2
Multicenter Study of Seliciclib (R-roscovitine) for Cushing Disease
- NCT03830151 · 13 participants · Phase 1
Hyperpolarized Carbon C 13 Pyruvate in Diagnosing Glioma in Patients With Brain Tumors
- NCT04573231 · 13 participants · Phase 2
Evaluation of PSMA in HER2- AR+ Metastatic Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI