Actively Recruiting
PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer
Led by University of Washington · Updated on 2026-01-14
80
Participants Needed
1
Research Sites
426 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed metastatic NSCLC in patients without prior chemotherapy or immunotherapy for advanced disease (stage IV or recurrent using AJCC/UICC 8th edition)
- Evidence of stage IV disease on imaging by CT, PET/CT, or MRI
- Plan to treat with a platinum doublet plus a PD1 or PDL1 inhibitor
- Adjuvant chemotherapy or concurrent chemoradiation for early stage disease allowed unless progression occurred within 6 months of completion
- Measurable disease per RECIST v1.1 at physician's discretion
- 18 years of age or older
- Eligible if progressed on or intolerant to FDA-approved targeted therapy for EGFR, BRAF mutations or ALK, ROS-1 translocations
- ECOG performance status 0-2
- Creatinine less than or equal to 2 mg/dL or creatinine clearance greater than 50 mL/min
- AST/ALT less than or equal to 5 times institutional upper limit of normal
- Total bilirubin less than or equal to 1.5 mg/dL
- Absolute neutrophil count greater than or equal to 1.5 x 10^9/L
- Platelet count greater than or equal to 100 x 10^9/L
- Ability to understand and comply with protocol and provide informed consent
You will not qualify if you...
- Any additional malignancy except non-melanoma skin cancer, in-situ breast cancer, low-risk prostate cancer, or malignancy diagnosed 3 or more years prior with no active treatment needed
- Prior treatment with anti-PD-1, PD-L1, PD-L2 agents or antibodies targeting other immunoregulatory mechanisms
- Serious or uncontrolled active infection that might cause false positives on PET/CT
- Any condition, therapy, or lab abnormality interfering with participation or study results, as judged by investigator
- Active autoimmune disease requiring systemic treatment (except replacement therapy like thyroxine, insulin, or physiologic corticosteroids)
- Known active and symptomatic CNS metastases or carcinomatous meningitis
- Stable or treated brain metastases allowed if prednisone dose is 10 mg or less per day
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
S
Stephen R. Bowen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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