Diclofenac + Immunotherapy for Lung Cancer

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJennifer Carlisle, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for patients with metastatic non-small cell lung cancer who are currently on single-agent immunotherapy. Participants should not have any health conditions that would interfere with the study or pose additional risks.

Inclusion Criteria

Life expectancy of ≥ 26 weeks

Creatinine clearance ≥ 45 ml/min

Serum glutamic oxaloacetic transaminase (SGOT) / serum gluatmic pyruvic transaminase (SGPT) ≤ 2.5 x institutional upper limit of normal

+11 more

Exclusion Criteria

Concurrent enrollment in another clinical study, unless it is non-therapeutic

I am not using two forms of birth control.

I have not started or received bevacizumab in the last 6 weeks.

+9 more

Participant Groups

The effectiveness of diclofenac, an anti-inflammatory drug, in enhancing the tumor-killing ability of existing immunotherapies like pembrolizumab, atezolizumab, nivolumab, or cemiplimab is being tested in this phase II trial.

1Treatment groups

Experimental Treatment

Group I: Treatment (diclofenac, immunotherapy)Experimental Treatment10 Interventions

Patients receive diclofenac PO BID and standard of care immunotherapy with pembrolizumab, atezolizumab, nivolumab or cemiplimab on day 1 of each cycle. Cycles repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and CT, PET, or MRI on study.

Diclofenac is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Voltaren for: