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

NCT05415358 | Active Not Recruiting DMC

• 2 other identifiers: LCI-LUN-IMM-BIO-001Pro00058707
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

Lung Cancer, Nonsmall Cell

Outcome Measures

Primary Outcomes (1)

• Disease progression status for the purpose of assessing its correlation with ctDNA measured at 0 months after pembrolizumab treatment completion

  Disease progression status determined by the treating investigator per standard care

  6 months after immune checkpoint inhibitor treatment completion

Secondary Outcomes (3)

• 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 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 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

Study Arms (1)

Single Arm

Biomarkers and ctDNA data generated from patients with metastatic non-small cell lung carcinoma who have completed first line immune checkpoint inhibitor monotherapy or immune checkpoint inhibitor platinum doublet combination therapy, and have, at immunotherapy discontinuation, completed at least 20 of an anticipated 24 months of immune checkpoint inhibitor treatment.

Other: Blood and tissue samples

Interventions

Blood and tissue samples OTHER

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.

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with metastatic non-small cell lung carcinoma who have completed first line immune checkpoint inhibitor monotherapy or immune checkpoint inhibitor platinum doublet combination therapy, and have, at immunotherapy discontinuation, completed at least 20 of an anticipated 24 months of immune checkpoint inhibitor treatment. These treatments are managed according to standard of care.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients who progress per the enrolling investigator while on treatment with immune checkpoint inhibitor treatment prior to enrollment.

Sponsors & Collaborators

• Atrium Health Levine Cancer Institute: collaborator
• Atrium Health Wake Forest Baptist: collaborator
• Wake Forest University Health Sciences: lead

Study Sites (2)

Atrium Health Levine Cancer

Charlotte, North Carolina, 28204, United States

Location

Atrium Health Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Subjects will be given the option to consent to have any additional blood specimens retained for future unplanned research.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Kathryn Mileham, MD

  Atrium Health Levine Cancer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: June 13, 2022
• Study Start: January 17, 2023
• Primary Completion (Estimated): September 1, 2035
• Study Completion (Estimated): September 1, 2035
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

US (2)