Circulating Tumor DNA Alterations in Non-small Cell Lung Cancer Patients Treated With Pembrolizumab

NCT04791215 | Terminated DMC

• 1 other identifier: AAAS7953
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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 treatment with pembrolizumab, and to understand how the immune system and cancer interact. Tests will be performed on tumor tissue and blood samples, and imaging assessments will be reviewed in order to monitor how well each patient responds to treatment. This is an observational study, so participants will not receive cancer treatment, other than the treatment received as standard of care.

Conditions

Non Small Cell Lung Cancer

Keywords

Cancer; Immune system; Lung Cancer; Pembrolizumab

Outcome Measures

Primary Outcomes (1)

• Radiologic response to immune checkpoint blockade (ICB) by clonal dynamics of serial ctDNA in 1st line NSCLC patients receiving pembrolizumab monotherapy.

  Radiologic response to immune checkpoint blockade (ICB) by clonal dynamics of serial ctDNA in 1st line NSCLC participants receiving pembrolizumab monotherapy. Imaging studies will be performed per RECIST 1.1. Radiologic response measured as the average time between randomization and detection of overt progression or response by ctDNA compared to RECIST 1.1.

  5 years

Secondary Outcomes (1)

• To characterize kinetic profiles of tumor mutations and see if they are predictive of overall survival (OS) and progression-free survival (PFS).

  5 years

Study Arms (2)

Prospective Sample Collection

Prospective sample collection from participants treated with pembrolizumab monotherapy at Columbia University Irving Medical Center under standard of care treatment. Prospective cohort subjects must consent to provide available archived tumor and blood for whole exome sequencing (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.

Other: Observational

Retrospective Sample Collection

Retrospective sample collection from participants that consent to provide genetic data from previous whole exome sequencing (WES) in the form of files for creation of plasma ctDNA panels.

Other: Observational

Interventions

Observational OTHER

All patients will be treated with standard of care pembrolizumab. After obtaining written informed consent, NSCLC participants will have serial blood collection. The blood collection (26 ml) should coincide with routine clinical blood draw to minimize participant discomfort if possible. No additional procedures will be performed other than phlebotomy. If additional biopsies or tumor resection are performed as part of routine standard of care throughout the course of the study, an additional 26 ml blood collection may be drawn for the study. Participants will remain on the study for as long as they are being followed or treated at Columbia University Irving Medical Center. Participants can withdraw from the study at any time.

Prospective Sample Collection; Retrospective Sample Collection

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

All male and females with a diagnosis of NSCLC with a protein that acts as a kind of "brake" to keep the body's immune responses under control PD-L1 TPS ≥1% and no known alterations in driver genes epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or Proto-oncogene tyrosine-protein kinase (ROS1).

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years
• Known history of autoimmune disease or other medical conditions that would preclude safe treatment with pembrolizumab.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and residual tissue from surgery or tumor biopsy will be collected.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms; Lung Neoplasms

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Brian Henick, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2021
• First Posted: March 10, 2021
• Study Start: February 1, 2020
• Primary Completion: April 12, 2023
• Study Completion: April 12, 2023
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

US (1)