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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

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.Check my eligibility
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.See study design
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

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

Side effects data

From 2022 Phase 3 trial • 541 Patients • NCT02041533
57%
Nausea
54%
Anaemia
51%
Fatigue
39%
Decreased appetite
36%
Malignant neoplasm progression
32%
Constipation
31%
Diarrhoea
30%
Cough
29%
Vomiting
29%
Dyspnoea
25%
Oedema peripheral
24%
Back pain
21%
Neutropenia
21%
Pyrexia
19%
Headache
19%
Hypomagnesaemia
18%
Arthralgia
16%
Asthenia
16%
Dizziness
16%
Neutrophil count decreased
15%
Thrombocytopenia
15%
Insomnia
14%
Hyponatraemia
14%
Rash
14%
Weight decreased
14%
Platelet count decreased
13%
Blood creatinine increased
13%
White blood cell count decreased
12%
Hypokalaemia
12%
Pruritus
12%
Abdominal pain
12%
Pain in extremity
11%
Myalgia
11%
Alanine aminotransferase increased
11%
Aspartate aminotransferase increased
10%
Alopecia
10%
Dry skin
10%
Hypoalbuminaemia
10%
Muscular weakness
10%
Chest pain
10%
Dysgeusia
10%
Pneumonia
10%
Productive cough
9%
Hypothyroidism
9%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Mucosal inflammation
9%
Peripheral sensory neuropathy
8%
Lacrimation increased
8%
Nasopharyngitis
8%
Non-cardiac chest pain
8%
Epistaxis
8%
Haemoptysis
8%
Stomatitis
8%
Dysphonia
7%
Chills
7%
Hypertension
7%
Bronchitis
7%
Dehydration
7%
Blood alkaline phosphatase increased
7%
Hyperglycaemia
7%
Hyperkalaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Hypophosphataemia
6%
Leukopenia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Hypotension
5%
Dry mouth
5%
Pain
5%
Malaise
5%
Musculoskeletal chest pain
5%
Rash maculo-papular
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Myocardial infarction
3%
Metastases to central nervous system
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Embolism
2%
Cardiac failure
2%
Sepsis
2%
Malignant pleural effusion
2%
Atrial fibrillation
2%
General physical health deterioration
2%
Adrenal insufficiency
1%
Circulatory collapse
1%
Bronchial obstruction
1%
Pneumothorax
1%
Ileus
1%
Atrial flutter
1%
Bone pain
1%
Small intestinal haemorrhage
1%
Pericardial effusion
1%
Femur fracture
1%
Pancytopenia
1%
Colitis
1%
Small intestinal obstruction
1%
Hypercalcaemia
1%
Confusional state
1%
Cancer pain
1%
Neoplasm progression
1%
Syncope
1%
Pericardial effusion malignant
1%
Superior vena cava syndrome
1%
Gastrointestinal haemorrhage
1%
Lung cancer metastatic
1%
Performance status decreased
1%
Respiratory tract infection
1%
Respiratory failure
1%
Tumour pain
1%
Appendicitis
1%
Skin infection
1%
Ataxia
1%
Seizure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Investigator Choice of Chemotherapy
Post Chemotherapy Optional Nivolumab
Nivolumab

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
~4740
Tetrahydrouridine
2007
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor
459 Previous Clinical Trials
32,275 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,388 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 Jul 2025