NCT06745882

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 318 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	Given on day 1 of every 21-day cycle.
DRUG	Carboplatin	Given on day 1 of every 21-day cycle.
DRUG	Pemetrexed	Given on day 1 of every 21-day cycle.
DRUG	Pembrolizumab	Given on day 1 of every 21-day cycle. After cycle 4 is given every 6 weeks.
DRUG	Abraxane	Given on days 1, 8, and 15 of each 21-day cycle.
DRUG	Paclitaxel	Given on day 1 of every 21-day cycle.

Timeline

• Start date: 2025-06-13
• Primary completion: 2030-01-01
• Completion: 2030-01-01
• First posted: 2024-12-20
• Last updated: 2026-04-02

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study