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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06731270
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Lung Non-Small Cell Carcinoma
  • Metastatic Lung Non-Small Cell Carcinoma
  • Stage III Lung Cancer AJCC v8
  • Stage IV Lung Cancer AJCC v8

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — BIOLOGICAL
    Given atezolizumab
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Cemiplimab — BIOLOGICAL
    Given cemiplimab
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Diclofenac Potassium — DRUG
    Given PO
  • Electronic Health Record Review — OTHER
    Ancillary studies
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Nivolumab — BIOLOGICAL
    Given nivolumab
  • Pembrolizumab — BIOLOGICAL
    Given pembrolizumab
  • Positron Emission Tomography — PROCEDURE
    Undergo PET

Study Details

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.

Key Dates

Start date
Apr 9, 2025
Status verified
Feb 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (diclofenac, immunotherapy)
    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.

Primary Outcome Measure

Clinical benefit rate (CBR) [ Time Frame: At 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Emory University Hospital MidtownAtlantaGeorgia30308
Jennifer W Carlisle
[email protected]
404-778-2304
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Jennifer W. Carlisle
[email protected]
404-778-2304
Jennifer W. Carlisle (PRINCIPAL_INVESTIGATOR)

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By research site
Emory University Hospital Midtown· Atlanta, GAEmory University Hospital/Winship Cancer Institute· Atlanta, GA

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