Actively Recruiting
Diclofenac for the Treatment of Patients With Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy
Led by Emory University · Updated on 2026-02-12
20
Participants Needed
2
Research Sites
142 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well diclofenac works in treating patients non-small cell lung cancer (NSCLC) that may have spread from where it first started (primary site) to other places in the body (metastatic) on single agent immunotherapy. Diclofenac, a type of non-steroidal anti-inflammatory (NSAID), blocks the body's production of a substance that causes inflammation and may decrease tumor growth and improve the effectiveness of immunotherapy. Immunotherapy with pembrolizumab, atezolizumab, nivolumab or cemiplimab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Giving diclofenac may kill more tumor cells in patients with metastatic NSCLC on single agent immunotherapy.
CONDITIONS
Official Title
Diclofenac for the Treatment of Patients With Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to sign informed consent
- Age 18 years or older at study entry
- Diagnosed with stage III or IV non-small cell lung cancer with advanced or metastatic disease
- Currently receiving FDA-approved single agent PD(L)-1 inhibitor immunotherapy (pembrolizumab, atezolizumab, nivolumab, or cemiplimab) for at least 12 weeks
- Radiographic evidence of clinical progression without immediate need to change therapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 26 weeks
- Absolute neutrophil count (ANC) of 1,000 cells/mm³ or higher
- Platelet count of 100,000 cells/mm³ or higher
- Hemoglobin level of 8 gm/dL or higher
- Creatinine clearance of 45 ml/min or higher
- Bilirubin level no greater than 1.5 times the institutional upper limit of normal (up to 3 times for Gilbert's syndrome patients)
- Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) levels no greater than 2.5 times the institutional upper limit of normal
- Ability to take oral medications
- Willing and able to follow study protocol including treatment and scheduled visits
You will not qualify if you...
- Enrolled concurrently in another clinical study unless it is non-therapeutic
- Currently receiving prophylactic or therapeutic anticoagulation therapy (e.g., warfarin, heparin, low molecular weight heparin, dabigatran, rivaroxaban, apixaban, edoxaban, betrixaban)
- Treatment with bevacizumab within the past 6 weeks or planned to start bevacizumab
- Abnormal coagulation markers with INR greater than 2
- Contraindications for NSAID therapy including chronic aspirin therapy for coronary artery disease or stroke, uncontrolled gastrointestinal ulcer disease, bleeding disorders, allergy or hypersensitivity to NSAIDs, advanced kidney disease, uncontrolled high blood pressure, or seizure disorders
- Female participants of childbearing potential unwilling or unable to use two forms of contraception
- Uncontrolled intercurrent illness
- History of another primary cancer except as noted in protocol
- History of active primary immunodeficiency or active infections such as tuberculosis, hepatitis B, or hepatitis C
- Use of immunosuppressive medications within 14 days before starting diclofenac, with some exceptions
- Receipt of live vaccine within 30 days before starting study medications
- Investigator judgment that patient is unsuitable or unlikely to comply with study procedures and requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
2
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
K
Kajona McCall
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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