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Anti-metabolites

Nivolumab + Decitabine/THU for Lung Cancer (PRECISE Trial)

Phase 2
Waitlist Available
Led By Nathan Pennell, MD,PhD
Research Sponsored by Case Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically-proven NSCLC
Patients with epidermal growth factor receptor (EGFR) or ALK alterations will need to have progressed on a TKI treatment
Must not have
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness
Known additional malignancy that is progressing or requires active treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years from end of treatment
Awards & highlights
No Placebo-Only Group

Summary

This trial will study whether adding THU to decitabine will improve how well decitabine works against non-small cell lung cancer (NSCLC) when given with the standard of care drug, nivolumab.

Who is the study for?
This trial is for adults with NSCLC who've had at least one prior systemic therapy but no immunotherapies. They must have adequate organ function, possibly including brain metastases under certain conditions, and not be on excluded medications or treatments. Participants need measurable disease per RECIST1.1 criteria, an ECOG status of 0-2, and the ability to undergo a biopsy.
What is being tested?
The PRECISE Trial is testing if THU-Dec (a combination of tetrahydrouridine-decitabine) with nivolumab works better than nivolumab alone for second-line treatment in NSCLC patients. Decitabine targets enzymes linked to tumor growth; THU helps decitabine stay longer in cells.
What are the potential side effects?
Potential side effects include immune-related reactions like inflammation in organs due to nivolumab, infusion reactions from both drugs, fatigue, possible blood disorders from decitabine's effect on DNA processes, and increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer diagnosis was confirmed through lab tests.
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My cancer has EGFR or ALK alterations and has worsened despite TKI treatment.
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My disease can be biopsied using a medical procedure.
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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an illness related to HIV or AIDS.
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I have another cancer that is getting worse or needs treatment.
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I have an active autoimmune disease.
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I have or had lung inflammation not caused by an infection.
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I am currently on medication for an infection.
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I have a history of HIV or active Hepatitis B/C.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years from end of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years from end of treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response by Response Evaluation Criteria in Solid Tumors (RECIST1.1)
Secondary study objectives
Overall Survival
Overall Survival - Long Term Follow-up (LTFU)
Time-to-Progression

Side effects data

From 2024 Phase 3 trial • 529 Patients • NCT02017717
80%
Fatigue
70%
Diarrhoea
70%
Headache
40%
Vomiting
40%
Aspartate aminotransferase increased
40%
Rash maculo-papular
40%
Alanine aminotransferase increased
40%
Lipase increased
30%
Partial seizures
30%
Hemiparesis
30%
Gait disturbance
30%
Fall
30%
Cough
30%
Dry skin
30%
Amylase increased
30%
Nausea
30%
Confusional state
20%
Malignant neoplasm progression
20%
Pyrexia
20%
Candida infection
20%
Mucosal infection
20%
Decreased appetite
20%
Back pain
20%
Dysphonia
20%
Hypotension
20%
Colitis
20%
Hyperthyroidism
20%
Oedema peripheral
20%
Muscular weakness
20%
Hypothyroidism
10%
Tinnitus
10%
Cushingoid
10%
Diabetic ketoacidosis
10%
Procedural haemorrhage
10%
Blood bilirubin increased
10%
Bradycardia
10%
Sinus tachycardia
10%
Hyperglycaemia
10%
Hypocalcaemia
10%
Neck pain
10%
Brain oedema
10%
Hydrocephalus
10%
Lethargy
10%
Seizure
10%
Hypertension
10%
Palpitations
10%
Cheilitis
10%
Presyncope
10%
Face oedema
10%
Oedema
10%
Conjunctivitis
10%
Enterocolitis infectious
10%
Oral candidiasis
10%
Pneumonia
10%
Sinusitis
10%
Staphylococcal infection
10%
Blood alkaline phosphatase increased
10%
Spinal pain
10%
Tremor
10%
Dizziness
10%
Dysarthria
10%
Urinary retention
10%
Dyspnoea exertional
10%
Nasal congestion
10%
Pneumonitis
10%
Dermatitis
10%
Erythema
10%
Rash
10%
Klebsiella infection
10%
Hypomagnesaemia
10%
Syncope
10%
Haemorrhage intracranial
10%
Pancreatitis
10%
Cholecystitis
10%
Upper respiratory tract infection
10%
Acute kidney injury
10%
Dermatitis bullous
10%
Lymphopenia
10%
Optic nerve disorder
10%
Visual impairment
10%
Dehydration
10%
Hypokalaemia
10%
Scoliosis
10%
Cognitive disorder
10%
Memory impairment
10%
Hallucination
10%
Insomnia
10%
Irritability
10%
Urinary incontinence
10%
Dyspnoea
10%
Dermatitis acneiform
10%
Pelvic venous thrombosis
10%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Arm N1+I3
Cohort 2: Arm B
Part A Cohort 1c: Arm N3+RT+TMZ
Part A Cohort 1d: Arm N3+RT
Part B Cohort 1c: Arm N3+RT+TMZ
Part B Cohort 1d: Arm N3+RT
Cohort 1: Arm N3
Cohort 1b: Arm N3+I1
Cohort 2: Arm N3

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Oral THU/decitabine + NivolumabExperimental Treatment3 Interventions
Oral THU \~10 mg/kg, followed by oral decitabine \~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days. This drug combination is administered with Nivolumab 3mg/kg IV Q2 weeks until progression
Group II: NivolumabActive Control1 Intervention
Nivolumab 3mg/kg IV Q2 weeks until progression; This is the standard of care for patients with NSCLC who have progressed on prior chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~5220
oral decitabine
2017
Completed Phase 2
~20
Tetrahydrouridine
2007
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
465 Previous Clinical Trials
32,572 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,886 Previous Clinical Trials
41,020,946 Total Patients Enrolled
Nathan Pennell, MD,PhDPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Media Library

Decitabine (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT02664181 — Phase 2
Non-Small Cell Lung Cancer Research Study Groups: Oral THU/decitabine + Nivolumab, Nivolumab
Non-Small Cell Lung Cancer Clinical Trial 2023: Decitabine Highlights & Side Effects. Trial Name: NCT02664181 — Phase 2
Decitabine (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02664181 — Phase 2
~2 spots leftby Oct 2025
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