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

Lung Cancer, Nonsmall Cell Clinical Trial

Official title: A Prospective Study Of Immune Signatures In Metastatic Non-Small Cell Lung Cancer (mNSCLC) Patients At Completion Of Pembrolizumab Either As Monotherapy Or In Combination With Chemotherapy In The First Line Setting

Status Recruiting

Clinical 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 pembrolizumab monotherapy or pembrolizumab-combination chemotherapy for mNSCLC.

Clinical Trial 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 pembrolizumab in the first line setting. The study will be conducted at various LCI locations; external sites may be added in the future. 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. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer, Nonsmall Cell
• Lung Neoplasms

• NCT number: NCT05415358
• Study type: Observational
• Source: Wake Forest University Health Sciences
• Contact: Alicia Patrick
• Phone: (980) 292-1746
• Email: Alicia.Patrick@atriumhealth.org
• Status: Recruiting
• Start date: January 17, 2023
• Completion date: September 2035