Recruiting

PD-1/L1 Blockade

Sponsor:

Jun Zhang, MD, PhD

Code:

NCT04636775

Conditions

NSCLC Stage IV

NSCLC, Recurrent

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Microbiome

Study Details

Brief summary:

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

NSCLC Stage IV

NSCLC, Recurrent

Study ID

NCT04636775

Start date

Jul 29, 2020

Status verified date

Dec, 2023

Completion date

Dec 31, 2024

Anticipated

Primary completion date

Aug 30, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

46 participants

Anticipated

Interventions and Outcome Measures

Arms

Immunotherapy naïve NSCLC patients

Microbiome in immunotherapy naïve NSCLC patients receiving PD-1/L1 blockade

Interventions

Microbiome

Nasal and buccal swabs, and stool sample, as well as the extracted DNAs

Primary outcome measure

  • Microbiome difference between patients with and without AEs>=grade 3 [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

KUCC Navigation

9135883671kucc_Navigation@kumc.edu

Locations

The University of Kansas Cancer Center (KUCC)

Recruiting

Fairway, Kansas, United States, 66205

Contacts

KUCC Navigator

913-588-3671kucc_navigation@kumc.edu

The University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

The University of Kansas Cancer Center, Westwood Campus

Recruiting

Kansas City, Kansas, United States, 66205

Contacts

KUCC Navigation

913-588-3671kucc_navigation@kumc.edu

More Information

Sponsor

Jun Zhang, MD, PhD

Last update posted

Dec 11, 2023

Last verified

Dec, 2023

Keywords

  • Advanced NSCLC
  • Metastatic NSCLC
  • Recurrent NSCLC

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jun Zhang, MD, PhD on 2023-12-11.