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Advanced Lung Non-Small Cell CarcinomaPhase 2NCT06731270

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

A Phase 2 study testing Atezolizumab, Biospecimen Collection and Cemiplimab in people with Advanced Lung Non-Small Cell Carcinoma and Metastatic Lung Non-Small Cell Carcinoma, run by Emory University at 2 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab, Biospecimen Collection and Cemiplimab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesUnited States
Study dates
9 Apr 2025to 1 Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kajona McCall contact

404-778-5087

kajohna.mccall@emory.edu

United States2 sites, 2 recruiting

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

    Jennifer W Carlisle, 404-778-2304, Jennifer.W.Carlisle@emory.edu

    Recruiting

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

    Jennifer W. Carlisle, 404-778-2304, Jennifer.W.Carlisle@emory.edu

    Jennifer W. Carlisle

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the clinical benefit rate of concomitant diclofenac potassium (diclofenac) and single agent checkpoint blockade.

SECONDARY OBJECTIVES:

  1. 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:

  1. 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 immunotherapy for advanced lung cancer.

II. To investigate the role of PD-L1 expression status in response to the addition of diclofenac daily oral therapy in patients who show early sings of progression on single agent immunotherapy for advanced lung cancer.

III. To evaluate the role of serum lactic acid levels in determining dose exposure to diclofenac.

IV. To evaluate the change in circulating immune parameters (CD4 T cells and B cells) with the addition of diclofenac to single agent immunotherapy.

  1. To evaluate the role of the tumor microenvironment at the time of diagnosis on efficacy.

OUTLINE:

Patients receive diclofenac orally (PO) twice daily (BID) and standard of care immunotherapy with pembrolizumab, atezolizumab, nivolumab or cemiplimab on day 1 of each cycle. Cycles repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and computed tomography (CT), positron emission tomography (PET), or magnetic resonance imaging (MRI) on study.

After completion of study treatment, patients are followed up every 12 weeks for up to 1 year.

Being tested
Atezolizumab, Biospecimen Collection, Cemiplimab, Computed Tomography, Diclofenac Potassium
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabBiological

    Also called MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A

    Given atezolizumab

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • CemiplimabBiological

    Also called Cemiplimab RWLC, Cemiplimab-rwlc, Libtayo, REGN 2810

    Given cemiplimab

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Diclofenac PotassiumDrug

    Also called Cambia, Cataflam, CGP 45840B, Zipsor

    Given PO

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • NivolumabBiological

    Also called ABP 206, BCD-263, BMS 936558, BMS-936558

    Given nivolumab

  • PembrolizumabBiological

    Also called BCD-201, GME 751, GME751, Keytruda

    Given pembrolizumab

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET

Study groups in NCT06731270
Study groupRoleWhat they receive
Treatment (diclofenac, immunotherapy)ExperimentalPatients receive diclofenac PO BID and standard of care immunotherapy with pembrolizumab, atezolizumab, nivolumab or cemiplimab on day 1 of each cycle. Cycles repeat every 21 or 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and CT, PET, or MRI on study.
Receives: Biological: Atezolizumab; Procedure: Biospecimen Collection; Biological: Cemiplimab; Procedure: Computed Tomography; Drug: Diclofenac Potassium; Other: Electronic Health Record Review; Procedure: Magnetic Resonance Imaging; Biological: Nivolumab; Biological: Pembrolizumab; Procedure: Positron Emission Tomography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At 12 weeks

Secondary outcomes (5)

  1. 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.

    Measured: Up to 30 days after last dose of study treatment

  2. 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.

    Measured: At 12 weeks

  3. 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.

    Measured: From initiation of treatment to progression or death up to 1 year

  4. 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.

    Measured: From diagnosis to death from any cause up to 1 year

  5. Duration of response (DOR)

    DOR will be estimated using the Kaplan-Meier method, and median DOR will be calculated. A 95% confidence interval will be estimated using the Brookmeyer-Crowley approach.

    Measured: From the date of first response to the date of the first progressive disease or death due to any cause up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start9 Apr 2025
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06731270
Sponsor's protocol ID
STUDY00006572
Other IDs
NCI-2024-07760, STUDY00006572, Winship6018-23, P30CA138292
Status last verified
Feb 2026
First submitted
9 Dec 2024
Last updated
12 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atezolizumab, Biospecimen Collection and Cemiplimab in people with Advanced Lung Non-Small Cell Carcinoma and Metastatic Lung Non-Small Cell Carcinoma, run by Emory University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kajona McCall (404-778-5087, kajohna.mccall@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical benefit rate (CBR) (time frame: At 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06731270.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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