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Official Title

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

Phase
Phase 2
Sponsor
Emory University
Enrollment
20
Timeline
Apr 2025 → Jan 2027
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Capable of signing informed consent
  • 2Age ≥ 18 years at time of study entry
  • 3Stage 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
  • 4May include frontline single agent immune checkpoint inhibitors (ICI), maintenance single agent ICI after chemo-ICI, or subsequent line therapy
  • 5Radiographic 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
  • 6Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • 7Life expectancy of ≥ 26 weeks
  • 8Absolute neutrophil count (ANC) ≥ 1,000 cell/mm\^3
  • 9Platelets ≥ 100,000 cells/mm\^3
  • 10Hemoglobin ≥ 8 gm/dL
  • 11Creatinine clearance ≥ 45 ml/ml
  • 12Bilirubin ≤ 1.5 x institutional upper limit of normal
  • 13Bilirubin must be ≤ 3 x institutional upper limit of normal in patients with documented Gilbert's syndrome
  • 14Serum glutamic oxaloacetic transaminase (SGOT) / serum gluatmic pyruvic transaminase (SGPT) ≤ 2.5 x institutional upper limit of normal
  • 15Ability to take oral medications
  • 16Willingness 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 Criteria

  • 1Concurrent enrollment in another clinical study, unless it is non-therapeutic
  • 2Prophylactic 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)
  • 3Treatment within the previous 6 weeks or planned initiation of bevacizumab
  • 4Abnormal markers of coagulation as measured by international normalized ratio (INR) \> 2
  • 5Contraindication 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
  • 6Female of childbearing potential unwilling or unable to use 2 methods of contraception, detailed in protocol
  • 7Uncontrolled intercurrent illness
  • 8History of another primary malignancy with exceptions noted in protocol
  • 9History of active primary immunodeficiency or active infection including tuberculosis, hepatitis B, hepatitis C
  • 10Current or prior use of immunosuppressive medication within 14 days before the first dose of diclofenac. There are exceptions to this criterion
  • 11Receipt of live attenuated vaccine within 30 days prior to the first dose of study medications
  • 12Judgment 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

Locations

2 sites participating in this study

Emory University Hospital Midtown

Atlanta, Georgia 30308

Recruiting

Jennifer W Carlisle

Jennifer.W.Carlisle@emory.edu404-778-2304

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia 30322

Recruiting

Jennifer W. Carlisle

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →