Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UCI 22-86 | Other Identifier | UCI CFCCC |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with PD1/L1 monotherapy |
| ||
| Treatment with PD1/L1 + chemotherapy |
| ||
| Treatment with Tyrosine Kinase Inhibitor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microbiome | Diagnostic Test | Stool and saliva samples will be collected |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiomes in advanced/metastatic NSCLC patients | To summarize the diversity and composition of gut microbiomes at baseline or prior to initiation of therapy | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in microbiome diversity and composition from baseline (prior to start of therapy) to first post-treatment evaluation scan. | Relative difference (and if necessary, relative ratio) between baseline and the first post-evaluation scan | Up to 2 years |
| Clinical Response Rate (RR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patient with advanced/metastatic non-small cell lung cancer (NSCLC)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center University of California, Irvine | Contact | 1-877-827-8839 | ucstudy@uci.edu | |
| University of California Irvine Medical | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Misako Nagasaka, MD,PhD | Chao Family Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Family Comprehensive Cancer Center University of California, Irvine | Recruiting | Orange | California | 92868 | United States |
Not provided
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D064307 | Microbiota |
| ID | Term |
|---|---|
| D008827 | Microbiological Phenomena |
| D058448 | Biota |
| D044822 | Biodiversity |
| D017753 | Ecosystem |
Not provided
Not provided
Not provided
Not provided
Not provided
Defined according to RECIST v1.1 criteria |
| Up to 2 years |
| Progression-Free Survival (PFS) | Duration from the start date of treatment to the date of progression or death from any cause, whichever occurs first. | Up to 2 years |
| Overall survival (OS) | Duration from the start date of treatment to the date of death from any cause. | Up to 2 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004777 |
| Environment |
| D055669 | Ecological and Environmental Phenomena |
| D001686 | Biological Phenomena |
| D004778 | Environment and Public Health |