Non Small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTMicrobiome
Stool and saliva samples will be collected
Sponsors
University of California, Irvine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiomes in advanced/metastatic NSCLC patients | Up to 2 years | To summarize the diversity and composition of gut microbiomes at baseline or prior to initiation of therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to 2 years | Duration from the start date of treatment to the date of death from any cause. |
| Change in microbiome diversity and composition from baseline (prior to start of therapy) to first post-treatment evaluation scan. | Up to 2 years | Relative difference (and if necessary, relative ratio) between baseline and the first post-evaluation scan |
| Clinical Response Rate (RR) | Up to 2 years | Defined according to RECIST v1.1 criteria |
| Progression-Free Survival (PFS) | Up to 2 years | Duration from the start date of treatment to the date of progression or death from any cause, whichever occurs first. |
Countries
United States
Contacts
CONTACTChao Family Comprehensive Cancer Center University of California, Irvine
CONTACTUniversity of California Irvine Medical
PRINCIPAL_INVESTIGATORMisako Nagasaka, MD,PhD
Chao Family Comprehensive Cancer Center
Outcome results
None listed