Immune Signature Analysis of Disease Progression in Post Immunotherapy Lung Cancer Patients
- Conditions
- Lung Cancer, Nonsmall Cell
- Interventions
- Other: Blood and tissue samples
- Registration Number
- NCT05415358
- Lead Sponsor
- Wake Forest University Health Sciences
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 23
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single Arm Blood and tissue samples Biomarkers and ctDNA data generated from patients with metastatic non-small cell lung carcinoma who have completed first line pembrolizumab monotherapy or pembrolizumab-platinum doublet combination therapy, and have, at immunotherapy discontinuation, completed at least 20 of an anticipated 24 months of pembrolizumab.
- Primary Outcome Measures
Name Time Method Disease progression status for the purpose of assessing its correlation with ctDNA measured at 0 months after pembrolizumab treatment completion 6 months after immune checkpoint inhibitor treatment completion Disease progression status determined by the treating investigator per standard care
- Secondary Outcome Measures
Name Time Method Disease progression status for the purpose of assessing its correlation with circulating effector T cell anergy at 0 months after pembrolizumab treatment completion 6 months after immune checkpoint inhibitor treatment completion Disease progression status determined by the treating investigator per standard care
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 6 months after immune checkpoint inhibitor treatment completion Disease progression status determined by the treating investigator per standard care
Disease progression status for the purpose of assessing its correlation with clonal circulating T cell diversity at 0 months after pembrolizumab treatment completion 6 months after immune checkpoint inhibitor treatment completion Disease progression status determined by the treating investigator per standard care
Trial Locations
- Locations (2)
Atrium Health Levine Cancer
🇺🇸Charlotte, North Carolina, United States
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
🇺🇸Winston-Salem, North Carolina, United States