Examining the microbiome in patients with advanced lung cancer receiving immunotherapy
Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)
This study is testing if the bacteria in the gut can help predict how well a new immunotherapy works for people with advanced lung cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 46 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Drugs / interventions | pembrolizumab, nivolumab, atezolizumab, avelumab, durvalumab, Immunotherapy |
| Locations | 3 sites (Fairway, Kansas and 2 other locations) |
| Trial ID | NCT04636775 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the role of the microbiome in predicting the effectiveness of PD-1/PD-L1 blockade therapy in immunotherapy-naïve patients with stage IV non-small cell lung cancer (NSCLC). By analyzing the microbiome, researchers hope to identify potential biomarkers that could indicate treatment response and the likelihood of adverse events. Participants will be receiving single-agent anti-PD-1/PD-L1 therapy, and the study will also explore factors that may modify the microbiome. The findings could lead to personalized treatment strategies for patients with advanced NSCLC.
Who should consider this trial
Good fit: Ideal candidates include immunotherapy-naïve patients with biopsy-proven stage IV or recurrent NSCLC who are set to receive PD-1/PD-L1 blockade therapy.
Not a fit: Patients who have previously received any form of cancer immunotherapy or those with significant psychiatric or social issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help tailor immunotherapy treatments based on individual microbiome profiles, potentially improving patient outcomes.
How similar studies have performed: While the role of the microbiome in cancer treatment is an emerging field, similar studies have shown promising results in other cancers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Fairway, Kansas and 2 other locations
- The University of Kansas Cancer Center (KUCC) — Fairway, Kansas, United States (Recruiting)
- The University of Kansas Medical Center — Kansas City, Kansas, United States (Recruiting)
- The University of Kansas Cancer Center, Westwood Campus — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Jun Zhang, MD, PhD — The University of Kansas Cancer Center
- Study coordinator: KUCC Navigation
- Email: kucc_Navigation@kumc.edu
- Phone: 9135883671
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.