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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT06745882
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 13, 2025
Status verified
Apr 2026
Primary completion
Jan 31, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
318 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Non-interventional prospective cohort and participants will receive standard of care pembrolizumab with or without chemotherapy.
  • Experimental: Cohort 2: arm A
    Cohort 2 Arm A will enroll patients with NSCLC with PD-L1 TPS status ≥1% and ctDNA tumor fraction low/negative and be treated with pembrolizumab monotherapy.
  • Experimental: Cohort 2: arm B
    Cohort 2 Arm B will enroll patients with NSCLC with any PD-L1 status and ctDNAtumor fraction intermediate/high -OR- PD-L1 TPS\<1% and any ctDNA level treated with chemotherapy plus pembrolizumab.

Primary Outcome Measure

Cohort 1: Real World Overall Survival (rwOS) [ Time Frame: Up to 36 Months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Jhanelle Gray, MD (PRINCIPAL_INVESTIGATOR)
Tiffany Apana, MSN, FNP-BC (SUB_INVESTIGATOR)
Alberto Chiappori, MD (SUB_INVESTIGATOR)
Benjamin Creelan, MD (SUB_INVESTIGATOR)
Eric Haura, MD (SUB_INVESTIGATOR)
Bruna Pellini, MD (SUB_INVESTIGATOR)
Andreas Saltos, MD (SUB_INVESTIGATOR)
Michael Shafique, MD (SUB_INVESTIGATOR)
Stephanee Smikker, MSPAS, PA-C (SUB_INVESTIGATOR)
Tawee Tanvetyanon, MD (SUB_INVESTIGATOR)
Sam Vafadar, PA-C, DHSc (SUB_INVESTIGATOR)
Charles Lu, MD (SUB_INVESTIGATOR)
Sonam Puri, MD (SUB_INVESTIGATOR)
Samantha Klebowski, APRN-C (SUB_INVESTIGATOR)
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287
Julie Brahmer, MD (PRINCIPAL_INVESTIGATOR)
TidalHealth Peninsula RegionalSalisburyMaryland20801
Milcah Larks, MD (PRINCIPAL_INVESTIGATOR)
Montefiore Medical Cancer CenterThe BronxNew York10461
Balazs Halmos, MD (PRINCIPAL_INVESTIGATOR)
Baptist Clinical Research InstituteMemphisTennessee38120
Osarenren Ogbeide, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Tampa, FL

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Moffitt Cancer Center· Tampa, FLJohns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDTidalHealth Peninsula Regional· Salisbury, MDMontefiore Medical Cancer Center· The Bronx, NYBaptist Clinical Research Institute· Memphis, TN

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