Immune Signature Analysis of Disease Progression in Post Immunotherapy Lung Cancer Patients
Study Details
Study Description
Brief Summary
The purpose of this study is to understand the recurrence of cancer for metastatic non-small cell lung cancer (mNSCLC) patients that have been treated with pembrolizumab either alone or together with chemotherapy as the first line of treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 have completed at least 85% of planned doses of pembrolizumab in the first line setting. For the purpose of calculating 85%, we will consider 400mg pembrolizumab every 6 weeks equal to 2 cycles of 200mg pembrolizumab every 21 days. The study will be conducted at various LCI locations. Subjects will have immune markers collected at screening, and every 3 months for up to 6 months or until disease progression, whichever comes first. We will also collect data from standard of care CT scans every 3 months for up to 6 months or until disease progression. Blood collection for ctDNA analysis will occur at screening and at progression or 6 months, whichever comes first. A portion of tumor tissue will be obtained and stored at time of progression to compare tumor inflammation with circulating immune related biomarkers.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Single Arm Biomarkers and ctDNA |
Other: Biomarkers and ctDNA
Blood and tissue will be collected to perform a ctDNA assessment to predict progression within 6 months of pembrolizumab discontinuation.
|
Outcome Measures
Primary Outcome Measures
- Identification of Biomarker Signature appearance or absence [6 months]
To identify a blood immune related biomarker signature (anergy of T-cell/loss of PD-L1, immune memory of B-cells and clonal T-cell expansion) at pembrolizumab discontinuation that is prognostic for disease progression within 6 months.
Secondary Outcome Measures
- To compare the change of blood immune related biomarkers [6 months]
To compare the change of blood immune related biomarkers between subjects who have progression within 6 months and those who do not progress at 6 months.
- Change in immune related Biomarkers [6 months]
To evaluate the association between immune related biomarkers at the time of enrollment and at the time of progression or at 6 months to PD-L1 status at time of diagnosis.
- Change in immune related Biomarkers - age, gender, smoking status, type of Non-small cell lung cancer (NSCLC) [6 months]
To evaluate the association of immune related biomarkers at the time of enrollment to age, gender, smoking status, type of NSCLC at diagnosis and treatment received (immunotherapy ± chemotherapy).
- Change in Demographic Information ctDNA Association [6 months]
To evaluate the association of ctDNA at the time of enrollment to age, gender, smoking status, type of NSCLC and treatment received (immunotherapy ± chemotherapy).
- Change in ctDNA Presence [6 months]
To evaluate the presence of residual ctDNA or de novo detections of ctDNA at time of completion of pembrolizumab as a prognostic marker for disease progression within 6 months.
- Change in Sustained Cytotoxic Immune Effector Activation [6 months]
To determine if sustained cytotoxic immune effector activation is associated with progression
- Change in Acquisition of T Cell Clones [6 months]
To determine if acquisition of T cell clones in the blood are associated with tumor inflammation at time of disease progression.
- Change in ctDNA Tumor Mutations [6 months]
To determine if ctDNA in the blood is associated with tumor mutations at time of disease progression.
Eligibility Criteria
Criteria
Inclusion Criteria
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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.
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Age greater than or equal to18 years at the time of consent.
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Patients with metastatic non-small cell lung carcinoma on first line pembrolizumab monotherapy or pembrolizumab-platinum doublet combination therapy who have completed at least 85% of planned doses of pembrolizumab.
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Planned discontinuation of pembrolizumab. Must have completed pembrolizumab prior to enrollment/collection of baseline sample.
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Patients are allowed to continue maintenance chemotherapy.
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Ability to understand and comply with study procedures for the entire length of the study.
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Known PD-L1 TPS prior to initiation of first-line treatment for NSCLC.
Exclusion Criteria
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Patients whose tumors harbor known gene abnormalities (e.g. EGFR, BRAF, ALK, ROS1).
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Patients who have ever received or are currently receiving other types of immunotherapy (nivolumab, ipilimumab, durvalumab or atezolizumab).
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Known pregnancy.
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Patients who progress while on treatment with pembrolizumab prior to enrollment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Levine Cancer Institute | Charlotte | North Carolina | United States | 28204 |
Sponsors and Collaborators
- Wake Forest University Health Sciences
Investigators
- Principal Investigator: Joanna Young, DO, Wake Forest University Health Sciences
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LCI-LUN-IMM-BIO-001
- 00058707