Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)

Study Overview
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Brief Summary
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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.

Official Title
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Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)

Conditions
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NSCLC Stage IV, NSCLC, Recurrent

Intervention / Treatment
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* Diagnostic Test: Microbiome


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immunotherapy naïve NSCLC patients<br>Microbiome in immunotherapy naïve NSCLC patients receiving PD-1/L1 blockade | Diagnostic Test: Microbiome<br>* Nasal and buccal swabs, and stool sample, as well as the extracted DNAs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome difference between patients with and without AEs>=grade 3 | Adverse events (AEs) will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microbiome difference between responders vs. nonresponders | Treatment response will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 | Through study completion, an average of 1 year | 
| Correlation of microbiome to tumor tissue PD-L1 expression | PD-L1 expression is per standard of care using IHC | Through study completion, an average of 1 year | 
| Correlation of microbiome to diet | Customized Diet Survey | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced NSCLC, Metastatic NSCLC, Recurrent NSCLC