Status:
RECRUITING
Immune Signature Analysis of Disease Progression in Post Immunotherapy Lung Cancer Patients
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
Atrium Health Levine Cancer Institute
Atrium Health Wake Forest Baptist
Conditions:
Lung Cancer, Nonsmall Cell
Eligibility:
All Genders
18+ years
Brief 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 anti...
Detailed Description
This is a prospective, non-randomized, pilot study. The target population is adults ≥18 years of age with metastatic non-small cell lung cancer that at immunotherapy discontinuation, have completed at...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- Enrollment/collection of baseline sample earlier than 7 days prior to scheduled last dose of immune checkpoint inhibitor treatment or more than 30 days after last dose of immune checkpoint inhibitor treatment.
- Patients whose tumors harbor known first line treatment druggable gene abnormalities (e.g. EGFR, BRAF, ALK, ROS1).
- Patients who have ever received or are currently receiving other types of immunotherapies (nivolumab, ipilimumab, durvalumab or atezolizumab).
- Known pregnancy.
- Patients who progress per the enrolling investigator while on treatment with immune checkpoint inhibitor treatment prior to enrollment.
Exclusion
Key Trial Info
Start Date :
January 17 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2035
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT05415358
Start Date
January 17 2023
End Date
September 1 2035
Last Update
July 24 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Atrium Health Levine Cancer
Charlotte, North Carolina, United States, 28204
2
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157