Clinical trial · Observational
Assess Diversity of Gut Microbiome in Met NSCLC in Correlation to Tx & Adverse Effects
A Pilot Study to Assess the Diversity of Gut Microbiome in Metastatic Non-Small Cell Lung Cancer (NSCLC) in Correlation to Treatment Effects and Adverse Effects
NCT06221800CI-TRIAL-00102484recruitingClinicalTrials.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 is a pilot study collecting data on the diversity and composition of gut microbiomes in subjects with advanced/metastatic Non-Small Cell Lung Cancer (NSCLC) while receiving treatment for NSCLC.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Microbiome | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Treatment with PD1/L1 monotherapy
- interventionNames
- Diagnostic Test: Microbiome
- label
- Treatment with PD1/L1 + chemotherapy
- interventionNames
- Diagnostic Test: Microbiome
- label
- Treatment with Tyrosine Kinase Inhibitor
- interventionNames
- Diagnostic Test: Microbiome
Primary outcomes (1)
- measure
- Gut microbiomes in advanced/metastatic NSCLC patients
- timeFrame
- Up to 2 years
- description
- To summarize the diversity and composition of gut microbiomes at baseline or prior to initiation of therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1\. Advanced/Metastatic non-small cell lung cancer NSCLC patients. * 2\. The patient himself/herself must be 18 years of age on day of signing informed consent. * 3\. The subject has signed the informed consent form. * 4\. The patient must be eligible to receive FDA approved and non-approved PD1 inhibitors (i.e. pembrolizumab, nivolumab) or PDL1 inhibitor (i.e. atezolizumab, durvalumab) either single agent or as combination therapy with chemotherapy, or be eligible to receive FDA approved and non-approved tyrosine kinase inhibitors. * 5\. The subject will be registered upon submission of the samples. When submitted on separate dates, the submission occurring later will be considered the date of registration Exclusion Criteria: * 1\. Those subjects who are determined clinically unstable of the participation of this study as determined by the PI or treating physician will be excluded and asked to focus on their treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.