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

Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · Jun 8, 2022

Keywords

ClinConnect Summary

This clinical trial is looking to understand how certain markers in the blood and immune system relate to the progression of lung cancer in patients who have been treated with pembrolizumab, a type of immunotherapy. Specifically, the study aims to see how these markers can help predict the disease progression in patients who have completed at least 20 months of treatment for metastatic non-small cell lung cancer (NSCLC). By studying these markers, researchers hope to gain insights that could improve future treatment strategies.

To participate in this trial, patients need to be at least 18 years old and have completed a significant portion of their first-line treatment with pembrolizumab. They should also have a known PD-L1 status before starting treatment. Participants will need to give their consent and may have their health data used for the study. If you join, you can expect to undergo some tests and provide samples of blood and tumor tissue to help researchers gather the information they need. It's important to note that patients with specific genetic abnormalities or those receiving other types of immunotherapy are not eligible for this trial.

Gender

ALL

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.