Study on Diclofenac for Treating Metastatic Non-Small Cell Lung Cancer with Immunotherapy

Sponsor: Emory University

Sponsor score: 40

ClinicalTrials ID:NCT06731270

Provider View

This clinical trial is exploring whether adding diclofenac, a common anti-inflammatory drug, can help improve the effectiveness of immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The purpose of this study is to see if diclofenac, a non-steroidal anti-inflammatory drug (NSAID), can help reduce tumor growth and enhance the effects of immunotherapy in patients with metastatic non-small cell lung cancer (NSCLC). The study involves patients who are already receiving immunotherapy drugs like pembrolizumab, atezolizumab, nivolumab, or cemiplimab. Researchers hope that diclofenac will help kill more cancer cells and improve treatment outcomes.

Description

The main goal of this study is to determine if combining diclofenac with immunotherapy provides clinical benefits for patients with metastatic non-small cell lung cancer (NSCLC). Researchers will also assess the safety and effectiveness of this combination treatment.

Participants will take diclofenac orally twice a day along with their regular immunotherapy treatment. The treatment cycles will repeat every 21 or 28 days, as long as the cancer does not progress or cause unacceptable side effects. During the study, patients will have blood samples taken and undergo imaging tests like CT, PET, or MRI scans to monitor their condition.

After completing the study treatment, patients will have follow-up visits every 12 weeks for up to a year to check on their health and the long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Able to provide informed consent.
  • Aged 18 years or older.
  • Diagnosed with stage III or IV non-small cell lung cancer (NSCLC) that is advanced or has spread to other parts of the body.
  • Currently receiving an FDA-approved immunotherapy drug (pembrolizumab, atezolizumab, nivolumab, or cemiplimab) for at least 12 weeks.
  • Showing signs of cancer progression that do not require an immediate change in therapy.
  • Have a performance status score of 0 to 2, indicating good overall health.
  • Life expectancy of at least 26 weeks.
  • Meet specific blood count and organ function criteria.
  • Able to take oral medications.
  • Willing to follow the study protocol, including attending scheduled visits and tests.

Exclusion Criteria

  • Participating in another clinical study, unless it is non-therapeutic.
  • Taking blood thinners or anticoagulant medications.
  • Recent or planned treatment with bevacizumab.
  • Abnormal blood clotting tests.
  • Conditions that prevent the use of NSAIDs, such as certain heart or stomach issues, allergies to NSAIDs, or severe kidney disease.
  • Women of childbearing potential not using effective contraception.
  • Uncontrolled health conditions or other cancers, with some exceptions.
  • Active infections or immune system disorders.
  • Recent use of immunosuppressive medications or live vaccines.
  • Determined by the investigator to be unsuitable for the study.

Locations

FACILITYZIPCITYSTATE
Emory University Hospital Midtown30308AtlantaGeorgia
Emory University Hospital/Winship Cancer Institute30322AtlantaGeorgia

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