NSCLC, Recurrent, NSCLC Stage IV
Conditions
Keywords
Advanced NSCLC, Metastatic NSCLC, Recurrent NSCLC
Brief summary
This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer, immunotherapy naive participants can predict the effectiveness of immunotherapy treatment as well as determine ahead of time adverse events and their severity. In addition, the investigator will look into microbiome changing modifiers.
Interventions
DIAGNOSTIC_TESTMicrobiome
Nasal and buccal swabs, and stool sample, as well as the extracted DNAs
Sponsors
Jun Zhang, MD, PhD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have tumor tissue biopsy-proven to be NSCLC * Must have a target lesion to evaluate treatment response * Immunotherapy naïve metastatic/advanced/recurrent NSCLC patients * Will receive single agent anti-PD-1/PD-L1 therapy (e.g. pembrolizumab, nivolumab, atezolizumab, avelumab or durvalumab, etc.). Patients can be on other interventional trial if they will be receiving single agent anti-PD-1/PD-L1
Exclusion criteria
* Prior treatment with any forms of cancer immunotherapy * Not competent to make medical decision, noncommunicative or noncompliant per treating physician's judgement * Not English-speaking * Patients that are pregnant * Prisoners * Students and employees * Psychiatric illness/social situations that would limit compliance with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome difference between patients with and without AEs>=grade 3 | Through study completion, an average of 1 year | Adverse events (AEs) will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbiome difference between responders vs. nonresponders | Through study completion, an average of 1 year | Treatment response will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 |
| Correlation of microbiome to tumor tissue PD-L1 expression | Through study completion, an average of 1 year | PD-L1 expression is per standard of care using IHC |
| Correlation of microbiome to diet | Through study completion, an average of 1 year | Customized Diet Survey |
Countries
United States
Contacts
Primary ContactKUCC Navigation
Outcome results
None listed