RecruitingPhase 2NCT06745882

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

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


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

318 participants

Start Date

Jun 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at real-world outcomes of pembrolizumab (an immunotherapy drug) treatment in Black/African American patients with advanced non-small cell lung cancer (NSCLC) — a group historically underrepresented in clinical trials — to understand whether results differ from other populations. **You may be eligible if...** - You are 18 or older - You self-identify as Black or African American - You have advanced or metastatic NSCLC (confirmed by biopsy) - You have not received prior chemotherapy or immunotherapy for your advanced lung cancer - Your tumor does not have EGFR, ALK, or ROS1 mutations - You have PDL1 test results available - You are in reasonably good physical condition (ECOG 0–2) **You may NOT be eligible if...** - You have active autoimmune disease requiring systemic treatment - You have active or untreated brain metastases - You have known interstitial lung disease or prior pneumonitis requiring steroids - You are pregnant or breastfeeding - You received a live vaccine within the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCisplatin

Given on day 1 of every 21-day cycle.

DRUGCarboplatin

Given on day 1 of every 21-day cycle.

DRUGPemetrexed

Given on day 1 of every 21-day cycle.

DRUGPembrolizumab

Given on day 1 of every 21-day cycle. After cycle 4 is given every 6 weeks.

DRUGAbraxane

Given on days 1, 8, and 15 of each 21-day cycle.

DRUGPaclitaxel

Given on day 1 of every 21-day cycle.


Locations(5)

Moffitt Cancer Center

Tampa, Florida, United States

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

Baltimore, Maryland, United States

TidalHealth Peninsula Regional

Salisbury, Maryland, United States

Montefiore Medical Cancer Center

The Bronx, New York, United States

Baptist Clinical Research Institute

Memphis, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06745882


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