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

Status: Recruiting
Location: See location...
Intervention Type: Radiation, Procedure, Drug, Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Washington
Fred Hutch/University of Washington Cancer Consortium
RECRUITING
Seattle
Contact Information
Primary
Stephen R. Bowen, PhD
srbowen@uw.edu
206-543-6559
Time Frame
Start Date: 2019-09-26
Estimated Completion Date: 2027-11-30
Participants
Target number of participants: 80
Treatments
Experimental: Research (PET/CT scan)
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.
Authors
Rafael Santana-Davila
Sponsors
Leads: University of Washington
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov