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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05415358
Recruitment Status : Recruiting
First Posted : June 13, 2022
Last Update Posted : January 18, 2023
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief Summary:
The purpose of this study is to examine the association between ctDNA/immune biomarkers and disease progression in patients who completed at least 85% of planned doses of pembrolizumab monotherapy or pembrolizumab-combination chemotherapy for mNSCLC.

Condition or disease Intervention/treatment
Lung Cancer, Nonsmall Cell Other: Blood and tissue samples

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; 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.
Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study Of Immune Signatures In Metastatic Non-Small Cell Lung Cancer (mNSCLC) Patients After Completion Of Pembrolizumab Either As Monotherapy Or In Combination With Chemotherapy In The First Line Setting
Actual Study Start Date : January 17, 2023
Estimated Primary Completion Date : November 2024
Estimated Study Completion Date : November 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Groups and Cohorts
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Group/Cohort Intervention/treatment
Single Arm
Biomarkers and ctDNA data generated from patients with metastatic non-small cell lung carcinoma who have completed first line pembrolizumab monotherapy or pembrolizumab-platinum doublet combination therapy, and have completed at least 85% of planned doses of pembrolizumab.
 Other: Blood and tissue samples
Blood and tissue will be collected to perform ctDNA and immune biomarkers assessment to predict progression within 6 months of pembrolizumab discontinuation.


Outcome Measures
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Primary Outcome Measures :
  1. Disease progression status for the purpose of assessing its correlation with ctDNA measured at 0 months after pembrolizumab treatment completion [ Time Frame: 6 months after pembrolizumab treatment completion ]
    Disease progression status determined by the treating investigator per standard care


Secondary Outcome Measures :
  1. Disease progression status for the purpose of assessing its correlation with circulating effector T cell anergy at 0 months after pembrolizumab treatment completion [ Time Frame: 6 months after pembrolizumab treatment completion ]
    Disease progression status determined by the treating investigator per standard care

  2. 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 [ Time Frame: 6 months after pembrolizumab treatment completion ]
    Disease progression status determined by the treating investigator per standard care

  3. Disease progression status for the purpose of assessing its correlation with clonal circulating T cell diversity at 0 months after pembrolizumab treatment completion [ Time Frame: 6 months after pembrolizumab treatment completion ]
    Disease progression status determined by the treating investigator per standard care


Biospecimen Retention:   Samples With DNA
Subjects will be given the option to consent to have any additional blood specimens retained for future unplanned research.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with metastatic non-small cell lung carcinoma who have completed first line pembrolizumab monotherapy or pembrolizumab-platinum doublet combination therapy, and have completed at least 85% of planned doses of pembrolizumab. These treatments are managed according to standard of care.
Criteria

Inclusion Criteria

  1. 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.
  2. Age greater than or equal to18 years at the time of consent.
  3. 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).
  4. Must have completed pembrolizumab no more than 30 days prior to enrollment/collection of baseline sample.
  5. Patients are allowed to continue maintenance chemotherapy.
  6. Ability to understand and comply with study procedures for the entire length of the study.
  7. Known PD-L1 prior to initiation of first-line treatment for NSCLC.

Exclusion Criteria

  1. Patients whose tumors harbor known first line treatment druggable gene abnormalities (e.g. EGFR, BRAF, ALK, ROS1).
  2. Patients who have ever received or are currently receiving other types of immunotherapies (nivolumab, ipilimumab, durvalumab or atezolizumab).
  3. Known pregnancy.
  4. Patients who progress per the enrolling investigator while on treatment with pembrolizumab prior to enrollment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05415358


Contacts
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Contact: Alicia Patrick (980) 292-1746 Alicia.Patrick@atriumhealth.org

Locations
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United States, North Carolina
Levine Cancer Institute Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Alicia Patrick    980-292-1746    Alicia.Patrick@atriumhealth.org   
Principal Investigator: Kathryn Mileham, MD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Kathryn Mileham, MD Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT05415358    
Other Study ID Numbers: LCI-LUN-IMM-BIO-001
00058707 ( Other Identifier: IRB )
First Posted: June 13, 2022    Key Record Dates
Last Update Posted: January 18, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms