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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years from end of treatment
Awards & highlights
PRECISE Trial 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.
PRECISE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung cancer diagnosis was confirmed through lab tests.
Select...
My cancer has EGFR or ALK alterations and has worsened despite TKI treatment.
Select...
My disease can be biopsied using a medical procedure.
Select...
I can take care of myself and am up and about more than half of my waking hours.
PRECISE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years from end of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years from end of treatment
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 • NCT0204153357%
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%
Pyrexia
21%
Neutropenia
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%
Abdominal pain upper
9%
Upper respiratory tract infection
9%
Hypothyroidism
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%
Bronchitis
7%
Blood alkaline phosphatase increased
7%
Chills
7%
Hypertension
7%
Dehydration
7%
Hyperkalaemia
7%
Hyperglycaemia
7%
Lymphocyte count decreased
7%
Anxiety
6%
Leukopenia
6%
Hypophosphataemia
6%
Pleural effusion
6%
Neuropathy peripheral
6%
Pneumonitis
6%
Oropharyngeal pain
5%
Rash maculo-papular
5%
Hypotension
5%
Musculoskeletal chest pain
5%
Malaise
5%
Pain
5%
Dry mouth
5%
Urinary tract infection
5%
Dyspepsia
5%
Gamma-glutamyltransferase increased
5%
Depression
5%
Muscle spasms
4%
Fall
4%
Pulmonary embolism
3%
Metastases to central nervous system
3%
Myocardial infarction
3%
Febrile neutropenia
3%
Musculoskeletal pain
3%
Chronic obstructive pulmonary disease
2%
Sepsis
2%
Malignant pleural effusion
2%
General physical health deterioration
2%
Adrenal insufficiency
2%
Atrial fibrillation
2%
Cardiac failure
2%
Embolism
1%
Hypercalcaemia
1%
Neoplasm progression
1%
Small intestinal haemorrhage
1%
Femur fracture
1%
Pericardial effusion malignant
1%
Cancer pain
1%
Confusional state
1%
Pneumothorax
1%
Circulatory collapse
1%
Bone pain
1%
Atrial flutter
1%
Bronchial obstruction
1%
Superior vena cava syndrome
1%
Syncope
1%
Performance status decreased
1%
Pancytopenia
1%
Colitis
1%
Pericardial effusion
1%
Gastrointestinal haemorrhage
1%
Ileus
1%
Small intestinal obstruction
1%
Lung cancer metastatic
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
PRECISE 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
~4750
Tetrahydrouridine
2007
Completed Phase 1
~30
Find a Location
Who is running the clinical trial?
Case Comprehensive Cancer CenterLead Sponsor
452 Previous Clinical Trials
31,897 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,140 Total Patients Enrolled
Nathan Pennell, MD,PhDPrincipal InvestigatorCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My lung cancer diagnosis was confirmed through lab tests.I have recently used certain medications or treatments.You have a history of mental health or drug problems.My organs are functioning well.I have had brain metastases but meet certain conditions for the study.I have an illness related to HIV or AIDS.I am currently on medication for an infection.I do not have any severe medical or mental health conditions.I have received treatment with specific medications before.Currently taking another experimental drug.I have a history of HIV or active Hepatitis B/C.I have not received a live vaccine in the last 30 days.I have another cancer that is getting worse or needs treatment.I have an active autoimmune disease.I have or had lung inflammation not caused by an infection.I haven't had heart, brain, or lung conditions in the last 6 months.I don't have any health issues that could affect the trial's results.I have had treatment for my disease but not with immunotherapy.My cancer has EGFR or ALK alterations and has worsened despite TKI treatment.My disease can be biopsied using a medical procedure.It is safe for me to undergo a biopsy.I agree to a biopsy before the study or have recent biopsy tissue available.You have a disease that can be measured using specific guidelines.I can take care of myself and am up and about more than half of my waking hours.
Research Study Groups:
This trial has the following groups:- Group 1: Oral THU/decitabine + Nivolumab
- Group 2: Nivolumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you elaborate on the other investigations involving Nivolumab?
"In 2004, Central Illinois Hematology Oncology Center began its research into nivolumab. Since then 372 clinical trials have been conducted and 816 are currently ongoing. In particular, Cleveland Ohio is conducting a considerable percentage of these studies."
Answered by AI
What maladies has Nivolumab been proven to alleviate?
"Nivolumab is an effective way to treat malignant neoplasms, unresectable melanoma, as well as squamous cell carcinoma."
Answered by AI
Are there still opportunities for potential participants to join this research?
"As per the information posted on clinicaltrials.gov, this medical trial is presently not open for patient recruitment - it was first launched in June 2017 and last updated August 2022. Nevertheless, there are 2,898 other studies actively recruiting participants at present."
Answered by AI
Has the FDA granted authorization to utilize Nivolumab?
"Despite the lack of evidence to support efficacy, Nivolumab's has some safety data associated with it that earned it a score of 2 on our assessment scale."
Answered by AI
What is the anticipated sample size of this clinical investigation?
"The trial is not currently enrolling, yet it was initially posted on June 6th 2017 and the most recent update came August 9th 2022. If patients are shopping for other medical studies involving non-small cell lung cancer, there are 2082 actively recruiting trials; 816 of them use Nivolumab as part of their intervention protocol."
Answered by AI
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