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Diclofenac with Immunotherapy for Metastatic Non-Small Cell Lung Cancer

This study is testing if adding diclofenac (an anti-inflammatory medicine) to your current immunotherapy (like pembrolizumab, atezolizumab, nivolumab, or cemiplimab) can help treat advanced or metastatic non-small cell lung cancer (NSCLC). Researchers believe diclofenac might reduce inflammation and improve how well immunotherapy works against cancer. You may be able to join if you are 18 or older, have Stage III or IV NSCLC, and are already receiving one of the approved single-agent immunotherapies. The main goal is to see if this combination provides a "clinical benefit" (meaning your cancer responds positively) after 12 weeks. This study is currently recruiting about 20 participants.

Study design
This is a Phase II interventional study, meaning it tests a new treatment combination. It plans to enroll 20 participants.
What's involved
You would take diclofenac by mouth twice daily, in addition to your standard immunotherapy. You will also have blood samples collected and undergo CT scans.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at 12 weeks, indicating follow-up for at least this period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06731270

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Emory University
~20 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:AtezolizumabBiospecimen CollectionCemiplimabComputed TomographyDiclofenac PotassiumElectronic Health Record Review

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical benefit rate (CBR)
Measured over At 12 weeks

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

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

2 sites across 1 states
Georgia2

Study leadership

  • Jennifer W Carlisle · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

Kajona McCall
[email protected]
404-778-5087
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Capable of signing informed consent
Age ≥ 18 years at time of study entry
Stage III or IV pathologically proven NSCLC with advanced or metastatic disease, currently on treatment with an Food and Drug Administration (FDA) approved single agent monoclonal antibody inhibiting the PD(L)-1 pathway (pembrolizumab, atezolizumab, nivolumab, or cemiplimab) for a minimum of 12 weeks
May include frontline single agent immune checkpoint inhibitors (ICI), maintenance single agent ICI after chemo-ICI, or subsequent line therapy
Radiographic evidence of clinical progression as determined by the treating physician, not warranting immediate change of therapy. Progressive disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria is not required. This can include mixed response, will need at least one growing lesion. Exposure to PD1 inhibitor for at least 12 weeks will minimize the risk of pseudo-progression
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Life expectancy of ≥ 26 weeks
Absolute neutrophil count (ANC) ≥ 1,000 cell/mm\^3
Platelets ≥ 100,000 cells/mm\^3
Hemoglobin ≥ 8 gm/dL
Creatinine clearance ≥ 45 ml/ml
Bilirubin ≤ 1.5 x institutional upper limit of normal
Bilirubin must be ≤ 3 x institutional upper limit of normal in patients with documented Gilbert's syndrome
Serum glutamic oxaloacetic transaminase (SGOT) / serum gluatmic pyruvic transaminase (SGPT) ≤ 2.5 x institutional upper limit of normal
Ability to take oral medications
Willingness and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up

Exclusion

Concurrent enrollment in another clinical study, unless it is non-therapeutic
Prophylactic or therapeutic anticoagulation therapy including but not limited to: warfarin, heparin, low molecular weight heparin, or direct oral anticoagulants, including: dabigatran (Pradaxa), rivaroxaban (Xarelto), apixaban (Eliquis), edoxaban (Savaysa), and betrixaban (Bevyxxa)
Treatment within the previous 6 weeks or planned initiation of bevacizumab
Abnormal markers of coagulation as measured by international normalized ratio (INR) \> 2
Contraindication for NSAID therapy including: chronic aspirin therapy for coronary artery disease (CAD), cerebrovascular accident (CVA), or other indication, uncontrolled gastrointestinal ulcerative disease, known bleeding diathesis, known allergy or hypersensitivity to NSAIDS, advanced renal disease, uncontrolled hypertension, known seizure disorder or others
Female of childbearing potential unwilling or unable to use 2 methods of contraception, detailed in protocol
Uncontrolled intercurrent illness
History of another primary malignancy with exceptions noted in protocol
History of active primary immunodeficiency or active infection including tuberculosis, hepatitis B, hepatitis C
Current or prior use of immunosuppressive medication within 14 days before the first dose of diclofenac. There are exceptions to this criterion
Receipt of live attenuated vaccine within 30 days prior to the first dose of study medications
Judgment by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions and requirements

What this trial measures

  • Clinical benefit rate (CBR)At 12 weeks

    CBR will be defined as complete response, partial response, and/or stable disease. Clinical response will be assessed using Response Evaluation Criteria for Solid Tumors (RECIST) 1.1 criteria. Clinical benefit rate will be reported as a proportion, with an exact 80% confidence interval estimated using the Clopper-Pearson method.