Lung Cancer, Nonsmall CellNCT05415358
Immune Signature Analysis of Disease Progression in Post Immunotherapy Lung Cancer Patients
An observational study of Lung Cancer, Nonsmall Cell, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, Nonsmall Cell
- What is being tested?
- Blood and tissue samples
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Jan 2023to Sep 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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. These treatments are managed according to standard of care.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atrium Health Levine Cancer
Charlotte, North Carolina, 28204
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: 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
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.
Read the 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 least 20 of an anticipated 24 months of planned doses of immune checkpoint inhibitor treatment in the first line setting. The study will be conducted at various Atrium Health Wake Forest Baptist Comprehensive Cancer Center locations. Subjects will have blood for ctDNA and immune markers collected at baseline, and every 3 months for up to approximately 6 months. Blood will be collected at disease progression if it occurs prior to 6 months, ensuring that the collection occurs prior to start of subsequent anti-cancer therapy. We will also collect data from standard of care CT scans every 3 months for up to 6 months or until disease progression. In patients undergoing standard of care biopsies, a portion of tumor tissue will be obtained and tested for tumor mutations. Archived tumor tissue collected pre-immunotherapy (if available) will also be tested.
- Conditions
- Lung Cancer, Nonsmall Cell
- Being tested
- Blood and tissue samples
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and tissue samplesOther
Blood and tissue will be collected to perform ctDNA and immune biomarkers assessment to predict progression within 6 months of immune checkpoint inhibitor treatment discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood and tissue samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease progression status for the purpose of assessing its correlation with ctDNA measured at 0 months after pembrolizumab treatment completion
Disease progression status determined by the treating investigator per standard care
Measured: 6 months after immune checkpoint inhibitor treatment completion
Secondary outcomes (3)
Disease progression status for the purpose of assessing its correlation with circulating effector T cell anergy at 0 months after pembrolizumab treatment completion
Disease progression status determined by the treating investigator per standard care
Measured: 6 months after immune checkpoint inhibitor treatment completion
Disease progression status for the purpose of assessing its correlation with the rate of effector to central memory T cell conversion at 0 months after pembrolizumab treatment completion
Disease progression status determined by the treating investigator per standard care
Measured: 6 months after immune checkpoint inhibitor treatment completion
Disease progression status for the purpose of assessing its correlation with clonal circulating T cell diversity at 0 months after pembrolizumab treatment completion
Disease progression status determined by the treating investigator per standard care
Measured: 6 months after immune checkpoint inhibitor treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start17 Jan 2023
- Primary completionSep 2035 (estimated)
- Study completionSep 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Nonsmall CellStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute, Atrium Health Wake Forest Baptist
- Responsible party
- Sponsor
- Investigators
- Kathryn Mileham, MD, Principal investigator, Atrium Health Levine Cancer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415358
- Sponsor's protocol ID
- LCI-LUN-IMM-BIO-001
- Other IDs
- Pro00058707
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2021
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05415358
- Acronym / sponsor ID
- LCI-LUN-IMM-BIO-001
- Conditions
- Lung Cancer, Nonsmall Cell
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Levine Cancer Institute, Atrium Health Wake Forest Baptist
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- Sep 2035 (estimated)
- Study completion
- Sep 2035 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 least 20 of an anticipated 24 months of planned doses of immune checkpoint inhibitor treatment in the first line setting. The study will be conducted at various Atrium Health Wake Forest Baptist Comprehensive Cancer Center locations. Subjects will have blood for ctDNA and immune markers collected at baseline, and every 3 months for up to approximately 6 months. Blood will be collected at disease progression if it occurs prior to 6 months, ensuring that the collection occurs prior to start of subsequent anti-cancer therapy. We will also collect data from standard of care CT scans every 3 months for up to 6 months or until disease progression. In patients undergoing standard of care biopsies, a portion of tumor tissue will be obtained and tested for tumor mutations. Archived tumor tissue collected pre-immunotherapy (if available) will also be tested.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | – | Other: Blood and tissue samplesBiomarkers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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. These treatments are managed according to standard of care.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and tissue samplesBlood and tissue will be collected to perform ctDNA and immune biomarkers assessment to predict progression within 6 months of immune checkpoint inhibitor treatment discontinuation. | Other | Single Arm |
Primary outcome
Disease progression status for the purpose of assessing its correlation with ctDNA measured at 0 months after pembrolizumab treatment completion
Time frame: 6 months after immune checkpoint inhibitor treatment completion
Disease progression status determined by the treating investigator per standard care
3 secondary outcomes
Disease progression status for the purpose of assessing its correlation with circulating effector T cell anergy at 0 months after pembrolizumab treatment completion
Time frame: 6 months after immune checkpoint inhibitor treatment completion
Disease progression status for the purpose of assessing its correlation with the rate of effector to central memory T cell conversion at 0 months after pembrolizumab treatment completion
Time frame: 6 months after immune checkpoint inhibitor treatment completion
Disease progression status for the purpose of assessing its correlation with clonal circulating T cell diversity at 0 months after pembrolizumab treatment completion
Time frame: 6 months after immune checkpoint inhibitor treatment completion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathryn Mileham, MD principal investigator
Atrium Health Levine Cancer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, Nonsmall Cell, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease progression status for the purpose of assessing its correlation with ctDNA measured at 0 months after pembrolizumab treatment completion (time frame: 6 months after immune checkpoint inhibitor treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.