A Prospective Study Of Immune Signatures In Metastatic Non-Small Cell Lung Cancer (mNSCLC) Patients At Completion Of Immune Checkpoint Inhibitor Treatment Either As Monotherapy Or In Combination With Chemotherapy In The First Line Setting

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The purpose of this study is to examine the association between ctDNA/immune biomarkers and disease progression in patients who, at immunotherapy discontinuation, have completed at least 20 of an anticipated 24 months of immune checkpoint inhibitor monotherapy or immune checkpoint inhibitor combination chemotherapy for mNSCLC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Informed consent and HIPAA authorization for release of personal health information signed by the subject. Note: Data from tumor samples, blood samples and radiographic scans prior to enrollment date may be used.

• Age greater than or equal to18 years at the time of consent.

• Patients with metastatic non-small cell lung carcinoma have completed first line who, at immunotherapy discontinuation, have completed at least 20 of an anticipated 24 months of immune checkpoint inhibitor monotherapy or pembrolizumab combination chemotherapy in the first line setting.

• Patients are allowed to continue maintenance chemotherapy.

• Ability to understand and comply with study procedures for the entire length of the study.

• Known PD-L1 prior to initiation of first-line treatment for NSCLC.

Locations
United States
North Carolina
Atrium Health Levine Cancer
RECRUITING
Charlotte
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
RECRUITING
Winston-salem
Contact Information
Primary
Margarita Dzhanumova
Margarita.Dzhanumova@advocatehealth.org
980-515-5300
Time Frame
Start Date: 2023-01-17
Estimated Completion Date: 2035-09
Participants
Target number of participants: 23
Treatments
Single Arm
Biomarkers and ctDNA data generated from patients with metastatic non-small cell lung carcinoma who have completed first line immune checkpoint inhibitor monotherapy or immune checkpoint inhibitor platinum doublet combination therapy, and have, at immunotherapy discontinuation, completed at least 20 of an anticipated 24 months of immune checkpoint inhibitor treatment.
Sponsors
Collaborators: Atrium Health Wake Forest Baptist, Atrium Health Levine Cancer Institute
Leads: Wake Forest University Health Sciences

This content was sourced from clinicaltrials.gov