Metastatic Lung Non-Small Cell CarcinomaNCT04151940
PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer
A study testing Positron Emission Tomography, Computed Tomography and Chemotherapy in people with Metastatic Lung Non-Small Cell Carcinoma and Recurrent Lung Non-Small Cell Carcinoma, run by University of Washington at 1 site in United States.
Trial summary
This study investigates the changes in positron emission tomography (PET)/computed tomography (CT) imaging scans during chemoimmunotherapy and radiation therapy treatment in patients with stage IV non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
- What is being tested?
- Positron Emission Tomography, Computed Tomography and Chemotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2019to 30 Nov 2027
- Phase
- Interventional
- 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
- Histologically-confirmed or cytologically-confirmed metastatic NSCLC in patients who have not received chemotherapy or immunotherapy for their advanced disease (stage IV or recurrent, using the American Joint Committee on Cancer [AJCC]/Union for International Cancer Control [UICC] 8th edition for staging)
- Evidence of stage IV disease on imaging by CT, PET/CT, or magnetic resonance imaging (MRI)
- Plan to treat with a platinum doublet with a PD1 or PDL1 inhibitor
- Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless subject progressed within 6 months of completion of regimen.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, at treating physician's discretion
- Subjects must be ≥ 18 years of age
Show all 14Show fewer
- Patients with known activating mutations in EGFR, BRAF or known translocation in ALK or ROS-1 are eligible provided they have progressed on or were intolerant to Food and Drug Administration (FDA) approved targeted therapy
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
- Creatinine =< 2 mg/dL or creatinine clearance > 50 mL/min
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 5x institutional upper limit of normal
- Total bilirubin =< 1.5 mg/dL
- Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (>= 1500 per mm^3)
- Platelet count >= 100 x 10^9/L (>=100,000 per mm^3)
- Capability to understand and comply with the protocol requirements and signed informed consent documents
Who cannot join
- Any known additional malignancy (with exception of non-melanoma skin cancer, in-situ breast cancer, low risk prostate cancer, or a malignancy diagnosed >= 3 years prior to the current NSCLC diagnosis and with no evidence of requiring active treatment)
- Had prior treatment with an anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms
- Has any serious or uncontrolled active infection that could create false positives on a PET/CT scan, in the opinion of the treating investigator
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Has an active autoimmune disease currently requiring systemic treatment (e.g. disease modifying agents, corticosteroids or immunosuppressive drugs)
- Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
- Has known, active, and symptomatic central nervous system (CNS) metastases and/or carcinomatous meningitis
- Patients with stable or previously treated brain metastases are eligible as long as they are not receiving more than 10 mg of prednisone, or equivalent, per day
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Stephen R. Bowen, PhD, 206-543-6559, srbowen@uw.edu
Stephen R. Bowen, PhD
About this study
Official title: An Interventional Study of PET/CT Changes During Chemoimmunotherapy and Radiation Therapy for Patients With Metastatic NSCLC (PET Bright)
This study investigates the changes in positron emission tomography (PET)/computed tomography (CT) imaging scans during chemoimmunotherapy and radiation therapy treatment in patients with stage IV non-small cell lung cancer. Analyzing changes in PET/CT imaging scans may help doctors assess and predict patterns of cancer response to chemoimmunotherapy and radiation therapy.
Read the detailed description
Patients undergo PET/CT scan within 4 weeks before starting standard of care chemoimmunotherapy and a second PET/CT scan within 5 days of the second chemoimmunotherapy cycle. Patients receiving standard of care radiation treatment undergo additional PET/CT scans within 4 weeks prior to radiation treatment and 1 month post-radiation treatment. Additionally, patients undergo blood sample collection on study. Patients may also undergo magnetic resonance imaging (MRI) as clinically indicated throughout the study.
- Conditions
- Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
- Being tested
- Positron Emission Tomography, Computed Tomography, Chemotherapy, Immunotherapy, Radiation Therapy
- Keywords
- Lung
- 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.
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, PET, PET scan, positron emission tomography scan
Undergo PET/CT scan
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, computerized axial tomography, computerized tomography
Undergo PET/CT scan
ChemotherapyDrug
Also called Chemo, Chemotherapy (NOS)
Receive standard of care chemotherapy
ImmunotherapyBiological
Also called Immunological, Immunological Therapy, Immunologically Directed Therapy
Receive standard of care immunotherapy
Radiation TherapyRadiation
Also called Cancer Radiotherapy, Irradiate, irradiated, Irradiation
Undergo standard of care radiation therapy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection
Undergo blood sample collection
Magnetic Resonance ImagingProcedure or surgery
Also called MRI, MRI Scan
Undergo MRI
| Study group | Role | What they receive |
|---|---|---|
| Research (PET/CT scan) | Experimental | Patients undergo PET/CT scan within 4 weeks before starting standard of care chemoimmunotherapy and a second PET/CT scan within 5 days of the second chemoimmunotherapy cycle. Patients receiving standard of care radiation treatment undergo additional PET/CT scans within 4 weeks prior to radiation treatment and 1 month post-radiation treatment. Additionally, patients undergo blood sample collection on study. Patients may also undergo MRI as clinically indicated throughout the study. Receives: Procedure: Positron Emission Tomography; Procedure: Computed Tomography; Drug: Chemotherapy; Biological: Immunotherapy; Radiation: Radiation Therapy; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actuarial disease progression rate
Will be compared between high-risk and low-risk subgroups of patients based on positron emission tomography/computed tomography imaging biomarker changes using a two-sample proportionality test.
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start26 Sep 2019
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic Lung Non-Small Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lei Deng, MD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151940
- Sponsor's protocol ID
- RG1005458
- Other IDs
- NCI-2019-07068, 10203, R01CA258997
- Status last verified
- Aug 2026
- First submitted
- 30 Oct 2019
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Yaseen F, Hippe DS, Cui S, Fu J, Kim Y, Grassberger C, Deng L, Ye T, Kinahan PE, Zeng J, Gennari JH, Bowen SR. Toward uncertainty-aware clinical decision support for treatment response prediction in metastatic NSCLC: integrating FDG-PET, T-cell repertoire, and cytokines with conformal prediction. Res Sq [Preprint]. 2026 Aug 27:rs.3.rs-10681426. doi: 10.21203/rs.3.rs-10681426/v1.
PubMed 42687919
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Interventional Study of PET/CT Changes During Chemoimmunotherapy and Radiation Therapy for Patients With Metastatic NSCLC (PET Bright)
- ClinicalTrials.gov ID
- NCT04151940
- Acronym / sponsor ID
- RG1005458
- Conditions
- Metastatic Lung Non-Small Cell Carcinoma, Recurrent Lung Non-Small Cell Carcinoma, Stage IV Lung Cancer AJCC v8
- Keywords
- Lung
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the changes in positron emission tomography (PET)/computed tomography (CT) imaging scans during chemoimmunotherapy and radiation therapy treatment in patients with stage IV non-small cell lung cancer. Analyzing changes in PET/CT imaging scans may help doctors assess and predict patterns of cancer response to chemoimmunotherapy and radiation therapy.
Detailed description
Patients undergo PET/CT scan within 4 weeks before starting standard of care chemoimmunotherapy and a second PET/CT scan within 5 days of the second chemoimmunotherapy cycle. Patients receiving standard of care radiation treatment undergo additional PET/CT scans within 4 weeks prior to radiation treatment and 1 month post-radiation treatment. Additionally, patients undergo blood sample collection on study. Patients may also undergo magnetic resonance imaging (MRI) as clinically indicated throughout the study.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research (PET/CT scan) | Experimental | Procedure: Positron Emission Tomography, Procedure: Computed Tomography, Drug: Chemotherapy, Biological: Immunotherapy, Radiation: Radiation Therapy, Procedure: Biospecimen Collection, Procedure: Magnetic Resonance ImagingPatients undergo PET/CT scan within 4 weeks before starting standard of care chemoimmunotherapy and a second PET/CT scan within 5 days of the second chemoimmunotherapy cycle. Patients receiving standard of care radiation treatment undergo additional PET/CT scans within 4 weeks prior to radiation treatment and 1 month post-radiation treatment. Additionally, patients undergo blood sample collection on study. Patients may also undergo MRI as clinically indicated throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically-confirmed or cytologically-confirmed metastatic NSCLC in patients who have not received chemotherapy or immunotherapy for their advanced disease (stage IV or recurrent, using the American Joint Committee on Cancer [AJCC]/Union for International Cancer Control [UICC] 8th edition for staging)
- Evidence of stage IV disease on imaging by CT, PET/CT, or magnetic resonance imaging (MRI)
- Plan to treat with a platinum doublet with a PD1 or PDL1 inhibitor
- Adjuvant chemotherapy or concurrent chemoradiation for early stage disease does not count as prior therapy unless subject progressed within 6 months of completion of regimen.
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1, at treating physician's discretion
Key exclusion criteria (8 listed)
- Any known additional malignancy (with exception of non-melanoma skin cancer, in-situ breast cancer, low risk prostate cancer, or a malignancy diagnosed >= 3 years prior to the current NSCLC diagnosis and with no evidence of requiring active treatment)
- Had prior treatment with an anti-PD-1, or PD-L1 or PD-L2 agent or an antibody targeting other immuno-regulatory receptors or mechanisms
- Has any serious or uncontrolled active infection that could create false positives on a PET/CT scan, in the opinion of the treating investigator
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
- Has an active autoimmune disease currently requiring systemic treatment (e.g. disease modifying agents, corticosteroids or immunosuppressive drugs)
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 |
|---|---|---|
| Positron Emission TomographyAlso: Medical Imaging, PET, PET scan, positron emission tomography scanUndergo PET/CT scan | Procedure or surgery | Research (PET/CT scan) |
| Computed TomographyAlso: CAT, CAT Scan, computerized axial tomography, computerized tomographyUndergo PET/CT scan | Procedure or surgery | Research (PET/CT scan) |
| ChemotherapyAlso: Chemo, Chemotherapy (NOS)Receive standard of care chemotherapy | Drug | Research (PET/CT scan) |
| ImmunotherapyAlso: Immunological, Immunological Therapy, Immunologically Directed TherapyReceive standard of care immunotherapy | Biological | Research (PET/CT scan) |
| Radiation TherapyAlso: Cancer Radiotherapy, Irradiate, irradiated, IrradiationUndergo standard of care radiation therapy | Radiation | Research (PET/CT scan) |
| Biospecimen CollectionAlso: Biological Sample CollectionUndergo blood sample collection | Procedure or surgery | Research (PET/CT scan) |
| Magnetic Resonance ImagingAlso: MRI, MRI ScanUndergo MRI | Procedure or surgery | Research (PET/CT scan) |
Primary outcome
Actuarial disease progression rate
Time frame: At 1 year
Will be compared between high-risk and low-risk subgroups of patients based on positron emission tomography/computed tomography imaging biomarker changes using a two-sample proportionality test.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Derived from this study: PubMed 42687919Yaseen F, Hippe DS, Cui S, Fu J, Kim Y, Grassberger C, Deng L, Ye T, Kinahan PE, Zeng J, Gennari JH, Bowen SR. Toward uncertainty-aware clinical decision support for treatment response prediction in metastatic NSCLC: integrating FDG-PET, T-cell repertoire, and cytokines with conformal prediction. Res Sq [Preprint]. 2026 Aug 27:rs.3.rs-10681426. doi: 10.21203/rs.3.rs-10681426/v1.
- Individual participant dataSharing planned: No
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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.
Lei Deng, MD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positron Emission Tomography, Computed Tomography and Chemotherapy in people with Metastatic Lung Non-Small Cell Carcinoma and Recurrent Lung Non-Small Cell Carcinoma, run by University of Washington at 1 site 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 14 inclusion and 8 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 6 Aug 2026. 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?
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 Stephen R. Bowen, PhD (206-543-6559, srbowen@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Actuarial disease progression rate (time frame: At 1 year). 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 NCT04151940, which also lists 1 linked publication.
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 6 Aug 2026.