PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer

Launched by UNIVERSITY OF WASHINGTON · Nov 1, 2019

Keywords

ClinConnect Summary

The clinical trial titled "PET/CT Changes During Chemoimmunotherapy and Radiation Therapy in Patients With Stage IV Non-small Cell Lung Cancer" is studying how imaging tests, specifically PET and CT scans, change during treatment for advanced lung cancer. The goal is to see if these imaging changes can help doctors understand how well the cancer is responding to treatments like chemotherapy combined with immunotherapy and radiation therapy. This understanding could improve future treatment plans for patients.

To be eligible for this trial, participants must have a confirmed diagnosis of stage IV non-small cell lung cancer and should not have received chemotherapy or immunotherapy for their advanced disease before. They should be planning to start treatment with a specific type of chemotherapy combined with immunotherapy. Participants can expect to undergo regular imaging scans to track the changes in their cancer during treatment. It's important to know that certain health conditions or previous treatments may exclude someone from participating, so potential participants should discuss their specific situation with their doctor.

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Eligibility 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