Status:
TERMINATED
Circulating Tumor DNA Alterations in Non-small Cell Lung Cancer Patients Treated With Pembrolizumab
Lead Sponsor:
Columbia University
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to learn how to use blood tests to better predict how patients with non-small cell lung cancer, who are taking pembrolizumab for cancer treatment, will respond to treatmen...
Detailed Description
The primary and secondary endpoints of this study are to determine the kinetics of Circulating tumor DNA (ctDNA) as defined by a set of patient-specific tumor mutations. The analysis will be undertake...
Eligibility Criteria
Inclusion
- Diagnosis of NSCLC with a protein that acts as a kind of "brake" to keep the body's immune responses under control called Programmed Death Ligand-1 (PD-L1) Tumor Proportion Score (TPS) ≥ 1% and no known alterations in driver genes epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or receptor tyrosine kinase (ROS1).
- Retrospective cohort: subjects must consent to provide genetic data from previous whole exome sequencing (WES) in the form of FASTQ/BAM files (files that represent aligned genetic sequences) for creation of plasma ctDNA panels.
- Prospective cohort: Subjects must consent to provide available archived tumor and blood for WES (matched tumor and normal) for creation of plasma ctDNA panels. The tumor sample must be from a site that was not previously irradiated or has progressed after radiation.
- Ability to understand and the willingness to sign a written informed consent document.
- Willing to comply with clinical trial instructions and requirements.
- Both men and women of all races and ethnic groups are eligible for this trial
Exclusion
- Age \<18 years
- Known history of autoimmune disease or other medical conditions that would preclude safe treatment with pembrolizumab.
Key Trial Info
Start Date :
February 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 12 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04791215
Start Date
February 1 2020
End Date
April 12 2023
Last Update
October 26 2024
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032