Lung Cancer Clinical Trial

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

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.

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Full 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; 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 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.

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Eligibility Criteria

Inclusion Criteria

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 who have completed first line pembrolizumab monotherapy or pembrolizumab-platinum doublet combination therapy who have completed at least 85% of planned doses of pembrolizumab (see Section 5 for calculation).
Must have completed pembrolizumab no more than 30 days prior to enrollment/collection of baseline sample.
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.

Exclusion Criteria

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 pembrolizumab prior to enrollment.

Study is for people with:

Lung Cancer

Estimated Enrollment:

70

Study ID:

NCT05415358

Recruitment Status:

Not yet recruiting

Sponsor:

Wake Forest University Health Sciences

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There is 1 Location for this study

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Levine Cancer Institute
Charlotte North Carolina, 28204, United States More Info
Alicia Patrick
Contact
980-292-1746
[email protected]
Kathryn Mileham, MD
Principal Investigator

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Study is for people with:

Lung Cancer

Estimated Enrollment:

70

Study ID:

NCT05415358

Recruitment Status:

Not yet recruiting

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

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