NCT05415358

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 23 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lung Cancer, Nonsmall Cell

Interventions

Type	Name	Description
OTHER	Blood and tissue samples	Blood and tissue will be collected to perform ctDNA and immune biomarkers assessment to predict progression within 6 months of immune checkpoint inhibitor treatment discontinuation.

Timeline

• Start date: 2023-01-17
• Primary completion: 2035-09-01
• Completion: 2035-09-01
• First posted: 2022-06-13
• Last updated: 2026-02-03

Locations

2 sites across 1 country: United States