Investigating PET/CT changes during treatment for advanced lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.