Clinical trial NCT04636775: Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)
Official title: Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: NSCLC Stage IV
NSCLC, Recurrent
Keywords: Advanced NSCLC
Metastatic NSCLC
Recurrent NSCLC
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Immunotherapy naïve metastatic/advanced/recurrent NSCLC patients

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.


Eligibility criteria: 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

Primary outcomes:
measure: Microbiome difference between patients with and without AEs>=grade 3
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Microbiome difference between responders vs. nonresponders
timeFrame: Through study completion, an average of 1 year
measure: Correlation of microbiome to tumor tissue PD-L1 expression
timeFrame: Through study completion, an average of 1 year
measure: Correlation of microbiome to diet
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Fairway
country: United States
facility: The University of Kansas Cancer Center (KUCC)
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Medical Center
state: Kansas
city: Kansas City
country: United States
facility: The University of Kansas Cancer Center, Westwood Campus
state: Kansas
Study officials:
affiliation: The University of Kansas Cancer Center
name: Jun Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Swami U, Zakharia Y, Zhang J. Understanding Microbiome Effect on Immune Checkpoint Inhibition in Lung Cancer: Placing the Puzzle Pieces Together. J Immunother. 2018 Oct;41(8):359-360. doi: 10.1097/CJI.0000000000000232.
citation: Strouse C, Mangalam A, Zhang J. Bugs in the system: bringing the human microbiome to bear in cancer immunotherapy. Gut Microbes. 2019;10(2):109-112. doi: 10.1080/19490976.2018.1511665. Epub 2018 Sep 5.