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

H. Lee Moffitt Cancer Center and Research Institute

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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 neoad…

Interventions

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.

Locations (5)

Moffitt Cancer Center
Tampa, Florida
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland
TidalHealth Peninsula Regional
Salisbury, Maryland
Montefiore Medical Cancer Center
The Bronx, New York
Baptist Clinical Research Institute
Memphis, Tennessee