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.
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.
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
Single group
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT scan
Computed Tomography
Procedure/SurgeryUndergo PET/CT scan
Chemotherapy
DrugReceive standard of care chemotherapy
Immunotherapy
Biological/VaccineReceive standard of care immunotherapy
Radiation Therapy
RadiationUndergo standard of care radiation therapy
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
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.
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University of Washington
Lead sponsor
National Cancer Institute (NCI)
Collaborator