Actively Recruiting
Phase II Study of Diclofenac with Single Agent PD(L)-1 Blockade in Metastatic Non-Small Cell Lung Cancer with Early Progression
Led by Emory University · Updated on 2026-02-12
20
Participants Needed
2
Research Sites
52 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
Researchers are evaluating the use of diclofenac, a non-steroidal anti-inflammatory drug (NSAID), in patients with metastatic non-small cell lung cancer (NSCLC) who are already receiving single agent immunotherapy. This phase II trial aims to assess whether diclofenac can improve treatment outcomes by reducing inflammation and tumor growth when combined with immunotherapy drugs such as pembrolizumab, atezolizumab, nivolumab, or cemiplimab. The study also explores changes in immune system markers and tumor environment related to this combination therapy. Participants receive diclofenac orally twice daily along with their standard immunotherapy given on the first day of each treatment cycle, which repeats every 21 or 28 days provided there is no disease progression or unacceptable side effects. During the study, patients undergo blood sample collections and imaging scans including CT, PET, or MRI to monitor disease status and immune changes. After completing treatment, patients are followed every 12 weeks for up to one year. Throughout the trial, researchers evaluate clinical benefit rate at 12 weeks as the primary outcome, along with safety, response rates, progression-free survival, overall survival, and duration of response. Blood tests and imaging help assess disease progression and immune response. The study includes close monitoring for side effects and treatment tolerance, with follow-up visits extending one year after treatment ends to observe long-term outcomes and patient health.
CONDITIONS
Brief 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 pathologically confirmed NSCLC with advanced or metastatic disease
- Currently receiving FDA-approved single agent PD(L)-1 inhibitor (pembrolizumab, atezolizumab, nivolumab, or cemiplimab) for at least 12 weeks
- Evidence of clinical progression not requiring immediate therapy change
- ECOG performance status between 0 and 2
- Life expectancy of 26 weeks or more
- Absolute neutrophil count at least 1,000 cells/mm^3
- Platelet count at least 100,000 cells/mm^3
- Hemoglobin level of 8 gm/dL or higher
- Creatinine clearance of 45 ml/min or higher
- Bilirubin no greater than 1.5 times institutional upper limit (up to 3 times if Gilbert's syndrome present)
- SGOT/SGPT no greater than 2.5 times institutional upper limit
- Able to take oral medications
- Willing and able to follow study treatment and visit schedule
You will not qualify if you...
- Enrolled in another therapeutic clinical study
- Receiving anticoagulation therapy (warfarin, heparin, direct oral anticoagulants)
- Treatment with or planned use of bevacizumab within 6 weeks
- Abnormal coagulation with INR greater than 2
- Contraindications to NSAIDs, including aspirin for certain conditions, bleeding disorders, allergy to NSAIDs, advanced kidney disease, uncontrolled hypertension, seizure disorders
- Female of childbearing potential unwilling or unable to use two forms of contraception
- Uncontrolled illness
- History of other primary cancers except as specified
- Active immunodeficiency or active infections like tuberculosis or hepatitis B/C
- Use of immunosuppressive medications within 14 days before diclofenac dose (with some exceptions)
- Receipt of live vaccine within 30 days prior to study
- Investigator judgment of unsuitability or inability to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21- or 28-day cycles until disease progression or unacceptable toxicity
Participants receive diclofenac orally twice daily along with standard immunotherapy on day 1 of each cycle. Treatment cycles repeat every 21 or 28 days without disease progression or unacceptable toxicity. Blood samples and imaging scans (CT, PET, or MRI) are collected during the study.
Visits every 3 to 4 weeks corresponding with each treatment cycle
Duration - Up to 1 year
After completing treatment, participants are followed up every 12 weeks for up to 1 year to monitor their health.
Follow-up visits every 12 weeks
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
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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