Investigating PET/CT changes during treatment for advanced lung cancer
An Interventional Study of PET/CT Changes During Chemoimmunotherapy and Radiation Therapy for Patients With Metastatic NSCLC (PET Bright)
This study is testing how PET and CT scans change during treatment for advanced lung cancer to see if they can help predict how well the treatment is working.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, prednisone, radiation |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT04151940 on ClinicalTrials.gov |
What this trial studies
This study examines how positron emission tomography (PET) and computed tomography (CT) imaging scans change during treatment with chemoimmunotherapy and radiation therapy in patients with stage IV non-small cell lung cancer. Patients will undergo PET/CT scans before starting treatment and after specific treatment cycles to assess and predict cancer response patterns. The goal is to enhance the understanding of treatment efficacy through imaging analysis.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically or cytologically confirmed stage IV non-small cell lung cancer who have not previously received chemotherapy or immunotherapy for their advanced disease.
Not a fit: Patients who have already received chemotherapy or immunotherapy for their advanced lung cancer or those with early-stage disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the ability to predict treatment responses in patients with advanced lung cancer, leading to more personalized and effective treatment strategies.
How similar studies have performed: Other studies have shown promise in using imaging changes to predict treatment responses, suggesting that this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Lei Deng, MD — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Stephen R. Bowen, PhD
- Email: srbowen@uw.edu
- Phone: 206-543-6559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.