RecruitingPhase 2NCT06731270

Diclofenac for the Treatment of Patients With Metastatic Non-small Cell Lung Cancer on Single Agent Immunotherapy

Phase II Study of Diclofenac Salvage in Patients Metastatic Non-Small Cell Lung Cancer With Early Signs of Progression on Single Agent PD(L)-1 Blockade


Sponsor

Emory University

Enrollment

20 participants

Start Date

Apr 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding diclofenac (a common anti-inflammatory medication) to ongoing immunotherapy can help slow or reverse cancer growth in people with advanced or metastatic non-small cell lung cancer (NSCLC) whose cancer is slowly progressing on a single immunotherapy drug. **You may be eligible if...** - You are 18 or older - You have Stage III or IV non-small cell lung cancer - You are currently receiving a single PD-(L)1 immunotherapy drug (such as pembrolizumab, atezolizumab, nivolumab, or cemiplimab) for at least 12 weeks - Your cancer is showing some signs of progression, but your doctor has decided it is not yet urgent enough to change your treatment **You may NOT be eligible if...** - Your cancer is rapidly progressing and needs immediate treatment change - You have known allergies or contraindications to diclofenac or similar anti-inflammatory drugs - You have serious kidney, liver, or cardiovascular disease - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAtezolizumab

Given atezolizumab

PROCEDUREBiospecimen Collection

Undergo blood sample collection

BIOLOGICALCemiplimab

Given cemiplimab

PROCEDUREComputed Tomography

Undergo CT

DRUGDiclofenac Potassium

Given PO

OTHERElectronic Health Record Review

Ancillary studies

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALNivolumab

Given nivolumab

BIOLOGICALPembrolizumab

Given pembrolizumab

PROCEDUREPositron Emission Tomography

Undergo PET


Locations(2)

Emory University Hospital Midtown

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

View Full Details on ClinicalTrials.gov

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NCT06731270


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