Recurrent Non-Small Cell Lung CarcinomaNCT02819024

Dexamethasone Effects in Patients With Refractory Non-Small Cell Lung Cancer Using FLT Positron Emission Tomography

A study testing Dexamethasone, Device for PET and Laboratory Biomarker Analysis in people with Recurrent Non-Small Cell Lung Carcinoma and Stage IIIA Non-Small Cell Lung Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Recurrent Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer
What is being tested?: Dexamethasone, Device for PET and Laboratory Biomarker Analysis
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 1 siteUnited States
Study dates: Jun 2016to 17 Oct 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients must have histologically or cytologically proven advanced non-squamous NSCLC. Patients may have newly diagnosed recurrent progressive or refractory disease which may be localized or wide spread.
No chemotherapy for at least 4 weeks and no radiation to the index lesion or clear progression in that lesion (greater than 20% increase in longest diameter).
Life expectancy of greater than 4 weeks
Absolute neutrophil count >= 1,000/mcL (measured within 2 weeks of registration)
No history of human immunodeficiency virus (HIV) or active infections
No history of diabetes

Show all 11Show fewer

No surgery in the last 2 weeks prior to study enrollment
Has not received Dex or another corticosteroid in over 4 weeks prior to enrollment
Ability to understand and the willingness to sign a written informed consent document
Agreed to FLT-PET imaging and signed consent and eligible FLT-PET protocol 2006-127
Registered with the clinical trials office of the Karmanos Cancer Center/Wayne State University

Who cannot join

Patients must have measureable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques (computed tomography [CT], magnetic resonance [MR] or PET); lesions in the previously irradiated area can be considered as measureable lesions as long as there has been an increase of at least 10 mm when compared to measurements obtained after completion of radiation

Trial locations and contacts

1 site in 1 country.

United States1 site

Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, 48201

Other trials in United States

About this study

Official title: Study of the Effects of Dexamethasone on Non-Small Cell Lung Cancer Using [F-18] FLT for Imaging With Positron Emission Tomography (PET)

This pilot research trial studies the effects of dexamethasone in patients with non-small cell lung cancer that has not responded after previous treatment. Drugs such as dexamethasone can affect how tumors grow and respond to treatments. Imaging tests, such as fluoro-L-thymidine (FLT) positron emission tomography , use a small amount of radioactive substance to show changes in tumor cells. Studying the effects of dexamethasone on lung tumors using FLT positron emission tomography may help doctors plan better treatments.

Read the detailed description

PRIMARY OBJECTIVES:

To evaluate the effect of dexamethasone (Dex) treatment in patients with relapsed non-small cell lung cancer (NSCLC) using 3'-fluorothymidine (FLT) positron emission tomography (PET) as measured by changes in tumor maximum standardized uptake value (SUVmax).

SECONDARY OBJECTIVES:

Assess the reversibility of Dex-mediated changes in tumor FLT retention following the withdrawal of Dex.

II. Measure tumor Glucocorticoid Receptor alpha expression (GRα) from recent patient biopsy samples.

III. Analyze blood samples obtained during imaging to determine serum Dex concentration and for senescence markers in circulating tumor cells.

OUTLINE:

Patients receive dexamethasone orally (PO) twice daily (BID) on days 1-5. Patients undergo 3 fluorothymidine F-18 (18F)-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.

Conditions: Recurrent Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
Being tested: Dexamethasone, Device for PET, Laboratory Biomarker Analysis, Positron Emission Tomography
Medical subject headings: Carcinoma, Non-Small-Cell Lung

What participants receive

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

DexamethasoneDrug
Also called Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex
Given PO BID
Device for PETDevice
Also called 18F-FLT, 3'-Deoxy-3'-(18F) Fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, Fluorothymidine F 18
Undergo 18F-FLT PET scan
Laboratory Biomarker AnalysisOther
Correlative studies
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan
Undergo 18F-FLT PET scan

Study groups in NCT02819024
Study group	Role	What they receive
Treatment (dexamethasone, 18F-FLT PET)	Experimental	Patients receive dexamethasone PO BID on days 1-5. Patients undergo 3 18F-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone. Receives: Drug: Dexamethasone; Device: Device for PET; Other: Laboratory Biomarker Analysis; Procedure: Positron Emission Tomography

What is being measured

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

Change in Tumor SUVmax Assessed by 18F-FLT PET Imaging
The primary endpoint is reported with mean and standard deviation
Measured: Baseline to day 9

Secondary outcomes (4)

Fold Change in Senescence Marker Gro-alpha
Fold change in senescence marker Gro-alpha from scan 1 to scan 3
Measured: Baseline to day 9
Fold Change in Senescence Marker Gro-beta
Fold change in senescence marker Gro-alpha from scan 1 to scan 3
Measured: Baseline to day 9
Fold Change in Senescence Marker MCP-1
Fold change in senescence marker Gro-alpha from scan 1 to scan 3
Measured: Baseline to day 9
Tumor Glucocorticoid Receptor Alpha Expression
Measured: Baseline

Timeline

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

Jun 201617 Oct 2019

First posted30 Jun 2016 (estimated)
Study startJun 2016
Primary completion17 Oct 2019
Study completion17 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Recurrent Non-Small Cell Lung CarcinomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02819024
Sponsor's protocol ID: 2015-174
Other IDs: NCI-2016-00881, 2015-174, P30CA022453
Status last verified: Jul 2025
First submitted: 20 Jun 2016
Last updated: 22 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Effects of Dexamethasone on Non-Small Cell Lung Cancer Using [F-18] FLT for Imaging With Positron Emission Tomography (PET)
ClinicalTrials.gov ID: NCT02819024
Acronym / sponsor ID: 2015-174
Conditions: Recurrent Non-Small Cell Lung Carcinoma, Stage IIIA Non-Small Cell Lung Cancer, Stage IIIB Non-Small Cell Lung Cancer, Stage IV Non-Small Cell Lung Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 6 participants (actual)
Lead sponsor: Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: Jun 2016
Primary completion: 17 Oct 2019 (actual)
Study completion: 17 Oct 2019 (actual)
First posted: 30 Jun 2016 (estimated)
Results: Posted 22 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To evaluate the effect of dexamethasone (Dex) treatment in patients with relapsed non-small cell lung cancer (NSCLC) using 3'-fluorothymidine (FLT) positron emission tomography (PET) as measured by changes in tumor maximum standardized uptake value (SUVmax).

SECONDARY OBJECTIVES:

Assess the reversibility of Dex-mediated changes in tumor FLT retention following the withdrawal of Dex.

II. Measure tumor Glucocorticoid Receptor alpha expression (GRα) from recent patient biopsy samples.

III. Analyze blood samples obtained during imaging to determine serum Dex concentration and for senescence markers in circulating tumor cells.

OUTLINE:

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (dexamethasone, 18F-FLT PET)	Experimental	Drug: Dexamethasone, Device: Device for PET, Other: Laboratory Biomarker Analysis, Procedure: Positron Emission TomographyPatients receive dexamethasone PO BID on days 1-5. Patients undergo 3 18F-FLT PET scans. One scan within 7 days prior to the start of dexamethasone, one scan on day 3 after the 5th dose of dexamethasone, and one scan 6-9 days after the last dose of dexamethasone.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (11 listed)

Patients must have histologically or cytologically proven advanced non-squamous NSCLC. Patients may have newly diagnosed recurrent progressive or refractory disease which may be localized or wide spread.
No chemotherapy for at least 4 weeks and no radiation to the index lesion or clear progression in that lesion (greater than 20% increase in longest diameter).
Life expectancy of greater than 4 weeks
Absolute neutrophil count >= 1,000/mcL (measured within 2 weeks of registration)
No history of human immunodeficiency virus (HIV) or active infections

Key exclusion criteria (1 listed)

Patients must have measureable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques (computed tomography [CT], magnetic resonance [MR] or PET); lesions in the previously irradiated area can be considered as measureable lesions as long as there has been an increase of at least 10 mm when compared to measurements obtained after completion of radiation

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexamethasoneAlso: Aacidexam, Adexone, Aknichthol Dexa, Alba-DexGiven PO BID	Drug	Treatment (dexamethasone, 18F-FLT PET)
Device for PETAlso: 18F-FLT, 3'-Deoxy-3'-(18F) Fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, Fluorothymidine F 18Undergo 18F-FLT PET scan	Device	Treatment (dexamethasone, 18F-FLT PET)
Laboratory Biomarker AnalysisCorrelative studies	Other	Treatment (dexamethasone, 18F-FLT PET)
Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography ScanUndergo 18F-FLT PET scan	Procedure or surgery	Treatment (dexamethasone, 18F-FLT PET)

Primary outcome

Change in Tumor SUVmax Assessed by 18F-FLT PET Imaging
Time frame: Baseline to day 9
The primary endpoint is reported with mean and standard deviation

4 secondary outcomes

Fold Change in Senescence Marker Gro-alpha
Time frame: Baseline to day 9
Fold Change in Senescence Marker Gro-beta
Time frame: Baseline to day 9
Fold Change in Senescence Marker MCP-1
Time frame: Baseline to day 9
Tumor Glucocorticoid Receptor Alpha Expression
Time frame: Baseline

Results and safety

Results posted to the registry on 22 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (Dexamethasone, 18F-FLT PET)	6	5

Primary outcome: Change in Tumor SUVmax Assessed by 18F-FLT PET Imaging

Time frame: Baseline to day 9. Mean (Standard Deviation). Unit: SUVmax

Measure	Treatment (Dexamethasone, 18F-FLT PET) n = 5
Value	-0.39 (0.39)

Treatment (Dexamethasone, 18F-FLT PET): p = 0.087, t-test, 2 sided

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the date of informed consent until the 3rd scan 6~8 days after scheduled Dex treatment, an average of 5 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (Dexamethasone, 18F-FLT PET)	0 of 5 (0%)	0 of 5 (0%)	0 of 5

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anthony Shields principal investigator

Barbara Ann Karmanos Cancer Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 1 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: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Tumor SUVmax Assessed by 18F-FLT PET Imaging (time frame: Baseline to day 9). 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 NCT02819024.

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 22 Aug 2025.