RECRUITING

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

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-04-09

Study Completion:2027-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06731270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 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	* 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

Inclusion Criteria

Exclusion 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 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

* 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

Contacts and Locations

Study Contact

Kajona McCall

CONTACT

404-778-5087

kajohna.mccall@emory.edu

Principal Investigator

Jennifer W Carlisle

PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Study Locations (Sites)

Emory University Hospital Midtown

Atlanta, Georgia, 30308

United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

United States

Collaborators and Investigators

Sponsor: Emory University

Jennifer W Carlisle, PRINCIPAL_INVESTIGATOR, Emory University Hospital/Winship Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-09

Study Completion Date2027-01-01

Study Record Updates

Study Start Date2025-04-09

Study Completion Date2027-01-01

Terms related to this study

Additional Relevant MeSH Terms

Advanced Lung Non-Small Cell Carcinoma
Metastatic Lung Non-Small Cell Carcinoma
Stage III Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8