RECRUITING

Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a non-registrational, cohort study enrolling eligible Black patients diagnosed with histologically or cytologically, advanced/metastatic NSCLC without known EGFR/ALK/ROS1 tumor mutations, and who are ≥ 18 years of age, ECOG performance status 0-2, and may have detectable ctDNA at baseline.

Official Title

Prospective Trial to Assess Real-world Outcomes and Predictive Biomarkers of Response to Pembrolizumab With or Without Chemotherapy in Black Patients With NSCLC

Quick Facts

Study Start:2025-01

Study Completion:2030-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06745882

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Be willing and able to provide written informed consent/assent. * Must be ≥ 18 years of age on day of signing informed consent. * Be Black / African American per self-report. * Have an ECOG performance status of 0- 2. * Have histologically or cytologically confirmed, advanced/metastatic NSCLC. * Be treatment naïve in the advanced/metastatic/recurrent disease setting. * No known EGFR/ALK/ROS1 tumor mutations. Liquid biopsies are acceptable. * Patients who received platinum-containing adjuvant chemotherapy, neoadjuvant chemotherapy or definitive chemoradiation and/or neoadjuvant and/or adjuvant immunotherapy and/or consolidation immunotherapy therapy given for locally advanced disease and developed recurrent (local or metastatic) disease ≥ 6 months of completing therapy are eligible. * Be planned/eligible to receive first-line therapy in the advanced/metastatic setting. * Have testing status for PDL1 tissue status. * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with any grade endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible. * Adequate organ function. * Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 180 days after the last dose if treated with pembrolizumab plus chemotherapy, or 120 days after the last dose if treated with pembrolizumab monotherapy. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. * Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 180 days after the last dose if treated with pembrolizumab plus chemotherapy.	* Does not plan or is ineligible to receive pembrolizumab with or without chemotherapy per institutional standard/treating provider. * History of allogenic tissue/solid organ transplant.

Inclusion Criteria

Exclusion Criteria

* Be willing and able to provide written informed consent/assent.
* Must be ≥ 18 years of age on day of signing informed consent.
* Be Black / African American per self-report.
* Have an ECOG performance status of 0- 2.
* Have histologically or cytologically confirmed, advanced/metastatic NSCLC.
* Be treatment naïve in the advanced/metastatic/recurrent disease setting.
* No known EGFR/ALK/ROS1 tumor mutations. Liquid biopsies are acceptable.
* Patients who received platinum-containing adjuvant chemotherapy, neoadjuvant chemotherapy or definitive chemoradiation and/or neoadjuvant and/or adjuvant immunotherapy and/or consolidation immunotherapy therapy given for locally advanced disease and developed recurrent (local or metastatic) disease ≥ 6 months of completing therapy are eligible.
* Be planned/eligible to receive first-line therapy in the advanced/metastatic setting.
* Have testing status for PDL1 tissue status.
* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with any grade endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible.
* Adequate organ function.
* Female subjects of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
* Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 180 days after the last dose if treated with pembrolizumab plus chemotherapy, or 120 days after the last dose if treated with pembrolizumab monotherapy. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
* Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 180 days after the last dose if treated with pembrolizumab plus chemotherapy.

* Does not plan or is ineligible to receive pembrolizumab with or without chemotherapy per institutional standard/treating provider.
* History of allogenic tissue/solid organ transplant.

Contacts and Locations

Study Contact

Anahid Aminpour

CONTACT

813-745-0287

anahid.aminpour@moffitt.org

Principal Investigator

Jhanelle Gray, MD

PRINCIPAL_INVESTIGATOR

Moffitt Cancer Center

Study Locations (Sites)

Moffitt Cancer Center

Tampa, Florida, 33612

United States

Collaborators and Investigators

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Jhanelle Gray, MD, PRINCIPAL_INVESTIGATOR, Moffitt Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01

Study Completion Date2030-01

Study Record Updates

Study Start Date2025-01

Study Completion Date2030-01

Terms related to this study

Keywords Provided by Researchers

Justice

Additional Relevant MeSH Terms

Non-small Cell Lung Cancer