RecruitingNot ApplicableNCT04151940

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)

Sponsor

University of Washington

Enrollment

80 participants

Start Date

Sep 26, 2019

Study Type

INTERVENTIONAL

Conditions

Metastatic Lung Non-Small Cell Carcinoma Stage IV Lung Cancer AJCC v8 Recurrent Lung Non-Small Cell Carcinoma

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. Analyzing changes in PET/CT imaging scans may help doctors assess and predict patterns of cancer response to chemoimmunotherapy and radiation therapy.

Eligibility

Min Age: 18 Years

Inclusion Criteria14

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

Exclusion Criteria8

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