Active Not RecruitingNot applicableNCT05415358
Official study title

Immune Signature Analysis of Disease Progression in Post Immunotherapy Lung Cancer Patients

Study 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.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedBlood and tissue samples

The study team can explain what participation involves.

Who it may be forLung Cancer, Nonsmall Cell

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Apr 22, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Not applicable

Observational

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Wake Forest University Health Sciences

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
Wake Forest University Health Sciences
Interventions being studied
Other: Blood and tissue samples
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. 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. 2. Age greater than or equal to18 years at the time of consent. 3. 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. 4. Patients are allowed to continue maintenance chemotherapy. 5. Ability to understand and comply with study procedures for the entire length of the study. 6. Known PD-L1 prior to initiation of first-line treatment for NSCLC.

Reasons someone may not be able to joinExclusion criteria

1. 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. 2. Patients whose tumors harbor known first line treatment druggable gene abnormalities (e.g. EGFR, BRAF, ALK, ROS1). 3. Patients who have ever received or are currently receiving other types of immunotherapies (nivolumab, ipilimumab, durvalumab or atezolizumab). 4. Known pregnancy. 5. Patients who progress per the enrolling investigator while on treatment with immune checkpoint inhibitor treatment prior to enrollment.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Atrium Health Levine CancerCharlotte, North Carolina
  • Atrium Health Wake Forest Baptist Comprehensive Cancer CenterWinston-Salem, North Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Apr 22, 2026. Always confirm current availability with the study team.

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