Clinical trial · Observational
Longitudinal Evaluation of Microbial and Host Signatures During Immunotherapy for Lung Cancer
- 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 study will prospectively collect airway, stool, and blood samples on 80 subjects with lung cancer undergoing immunotherapy. Investigators will evaluate airway/stool microbial signatures associated with local (lower airway) and systemic (blood) immune tone.They will then study whether microbiota and/or host signatures predict subjects' response by longitudinal assessment of the progression free survival. They will also repeat sampling after 8 weeks of immunotherapy to expand our mechanistic understanding of the response to treatment.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bronchoscopy | Other | — | UNRESOLVED |
| Research Procedures | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Advanced stage unresectable Non-Small Cell Lung Cancer
- description
- Adult patients with a diagnosis of advanced stage unresectable Non-Small Cell Lung Cancer and indication for PD-1 blockade treatment (either as monotherapy or combined with chemotherapy)
- interventionNames
- Other: Bronchoscopy
- Other: Research Procedures
Primary outcomes (3)
- measure
- Progression-free survival (PFS)
- timeFrame
- 3 Years
- description
- over ≥ 1-year follow-up
- measure
- Microbiota signatures in lower and upper airways
- timeFrame
- 3 Years
- measure
- Microbiota signatures in stool
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients with a diagnosis of advanced stage unresectable Non-Small Cell Lung Cancer and indication for PD-1 blockade treatment (either as monotherapy or combined with chemotherapy) Exclusion Criteria: * Antibiotic, steroid, or chemotherapy received within the prior month since these are possible confounders that may impact the microbiome and the host immunity. * Brain metastasis (as evaluated by MRI obtained as part of standard of care staging evaluation) * FEV1\<50% predicted * Cardiovascular disease (defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure) * Renal disease * Coagulopathy * Liver disease
References
Publications (0)
Data not yet available