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.
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
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
Single group
Atezolizumab
Biological/VaccineGiven atezolizumab
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Cemiplimab
Biological/VaccineGiven cemiplimab
Computed Tomography
Procedure/SurgeryUndergo CT
Diclofenac Potassium
DrugGiven PO
Electronic Health Record Review
Other interventionAncillary studies
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Nivolumab
Biological/VaccineGiven nivolumab
Pembrolizumab
Biological/VaccineGiven pembrolizumab
Positron Emission Tomography
Procedure/SurgeryUndergo PET
Clinical benefit rate (CBR)
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.
Incidence of adverse events (AEs)
AEs severity will be assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Descriptive statistics will be reported, using frequencies and percentages for each toxicity.
Objective response rate (ORR)
ORR will be defined per RECIST 1.1. ORR will be reported as a proportion, with an exact 95% confidence interval estimated using the Clopper-Pearson method.
Progression-free survival (PFS)
PFS will be determined by RECIST 1.1. PFS will be estimated using the Kaplan-Meier method, and a 95% confidence interval for median PFS will be estimated using the Brookmeyer-Crowley approach.
Overall survival (OS)
OS will be estimated using the Kaplan-Meier method, and median OS will be calculated. A 95% confidence interval will be estimated using the Brookmeyer-Crowley approach.
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Emory University
Lead sponsor
National Cancer Institute (NCI)
Collaborator
