Clinical trial · Observational
Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)
NCT04636775CI-TRIAL-00072109unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC, Recurrent | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| NSCLC Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microbiome | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Immunotherapy naïve NSCLC patients
- description
- Microbiome in immunotherapy naïve NSCLC patients receiving PD-1/L1 blockade
- interventionNames
- Diagnostic Test: Microbiome
Primary outcomes (1)
- measure
- Microbiome difference between patients with and without AEs>=grade 3
- timeFrame
- Through study completion, an average of 1 year
- description
- Adverse events (AEs) will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Secondary outcomes (3)
- measure
- Microbiome difference between responders vs. nonresponders
- timeFrame
- Through study completion, an average of 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- BACKGROUNDSwami 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. PMID 29781826
- BACKGROUNDStrouse 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. PMID 30183502