Analyzing immune signatures in lung cancer patients after immunotherapy

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

This study is testing how blood samples can help us understand the immune response and tumor changes in lung cancer patients who have been on immunotherapy for a while.

Quick facts

• Study type: Observational
• Enrollment: 23 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wake Forest University Health Sciences (Academic / other)
• Drugs / interventions: pembrolizumab, nivolumab, ipilimumab, durvalumab, atezolizumab, chemotherapy, immunotherapy
• Locations: 2 sites (Charlotte, North Carolina and 1 other locations)
• Trial ID: NCT05415358 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the relationship between circulating tumor DNA (ctDNA) and immune biomarkers with disease progression in patients with metastatic non-small cell lung cancer (mNSCLC) who have undergone at least 20 months of immune checkpoint inhibitor therapy. Participants will have blood samples collected at baseline and every three months for up to six months, or at disease progression, to analyze immune responses and tumor mutations. The study will also utilize standard care CT scans to monitor disease status during this period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with metastatic non-small cell lung cancer who have completed at least 20 months of first-line immune checkpoint inhibitor therapy.

Not a fit: Patients who have not completed the required duration of immunotherapy or those with other types of lung cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of immune responses in lung cancer patients, potentially leading to improved treatment strategies.

How similar studies have performed: While this approach is relatively novel, similar studies have shown promise in understanding immune responses in cancer treatment.

Eligibility criteria

Inclusion 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.

Exclusion 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.

Where this trial is running

Charlotte, North Carolina and 1 other locations

• Atrium Health Levine Cancer — Charlotte, North Carolina, United States (Recruiting)
• Atrium Health Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Kathryn Mileham, MD — Atrium Health Levine Cancer
• Study coordinator: Alicia Patrick

Conditions Lung Cancer, Nonsmall Cell