NCT05415358Active, not recruiting
Immune Signature Analysis of Disease Progression in Post Immunotherapy Lung Cancer Patients
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
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 23 (estimated)
- First submitted
- 6 Dec 2021
- Start date
- 17 Jan 2023
- Primary completion date
- 30 Sept 2035
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Lung cancer
- NCT number
- NCT05415358
What you commit to
- Study type: Observational
- Planned participants: 23
- From 17 Jan 2023 to the primary completion date, 30 Sept 2035
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 who have ever received or are currently receiving other types of immunotherapies (nivolumab, ipilimumab, durvalumab or atezolizumab).
- Patients who progress per the enrolling investigator while on treatment with immune checkpoint inhibitor treatment prior to enrollment.
Lab values
- Patients whose tumors harbor known first line treatment druggable gene abnormalities (e.g. EGFR, BRAF, ALK, ROS1).
Other
- Known pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Atrium Health Levine Cancer Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Atrium Health Wake Forest Baptist Comprehensive Cancer Center Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.