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
Emory University
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.
Description
PRIMARY OBJECTIVE: I. To evaluate the clinical benefit rate of concomitant diclofenac potassium (diclofenac) and single agent checkpoint blockade. SECONDARY OBJECTIVES: I. To evaluate the safety and tolerability of concomitant diclofenac and single agent checkpoint blockade. II. To evaluate the efficacy of concomitant diclofenac and single agent checkpoint blockade in NSCLC. EXPLORATORY OBJECTIVES: I. To evaluate the change in immunophenotype in circulating CD8 T cells following initiation of diclofenac oral therapy in patients who show early sings of progression on single agent immunoth…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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…
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
Locations (2)
- Emory University Hospital MidtownAtlanta, Georgia
- Emory University Hospital/Winship Cancer InstituteAtlanta, Georgia