Immune Signature Analysis of Disease Progression in Post Immunotherapy Lung Cancer Patients (NCT05415358) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Immune Signature Analysis of Disease Progression in Post Immunotherapy Lung Cancer Patients
United States23 participantsStarted 2023-01-17
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Disease progression status for the purpose of assessing its correlation with ctDNA measured at 0 months after pembrolizumab treatment completion
Timeframe: 6 months after immune checkpoint inhibitor treatment completion