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NCT04151940Recruiting

PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer

An Interventional Study of PET/CT Changes During Chemoimmunotherapy and Radiation Therapy for Patients With Metastatic NSCLC (PET Bright)

Source: ClinicalTrials.gov · Last updated 6 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
80 (estimated)
First submitted
30 Oct 2019
Start date
26 Sept 2019
Primary completion date
30 Nov 2027
Lead sponsor
University of Washington
Diseases
Lung cancer
NCT number
NCT04151940

What you commit to

  • Study type: Interventional
  • Planned participants: 80
  • From 26 Sept 2019 to the primary completion date, 30 Nov 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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 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

Other illness

  • 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 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

Lab values

  • 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

Who the study is looking for

  • 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
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fred Hutch/University of Washington Cancer Consortium
Coordinator of this site? Confirm its status
SeattleUnited StatesRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.