Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC (NCT06745882) | Clinical Trial Compass
RecruitingPhase 2
Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC
United States318 participantsStarted 2025-06-13
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cohort 1: Real World Overall Survival (rwOS)
Timeframe: Up to 36 Months
2
Cohort 2 Arm A: Progression Free Survival (PFS)
Timeframe: Up to 36 Months
3
Cohort 2 Arm B: Progression Free Survival (PFS)
Timeframe: Up to 36 Months
Trial details
NCT IDNCT06745882
SponsorH. Lee Moffitt Cancer Center and Research Institute