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

Study 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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedCisplatin and Carboplatin

Plus 4 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Metastatic or stage IV

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Sep 21, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 2

Interventional

Where is it offered?11 U.S. locations

Locations may change over time.

Who runs it?H. Lee Moffitt Cancer Center and Research Institute

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Interventions being studied: Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Pembrolizumab; Drug: Abraxane; Drug: Paclitaxel

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Metastatic or stage IV→

Treatment approach

Immunotherapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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 will be required.
Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of the study through 180 days after the last dose if treated with pembrolizumab plus chemotherapy, or 120 days after the last dose if treated with pembrolizumab monotherapy. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year.
Male subjects should agree to use an adequate method of barrier contraception starting with the first dose of study therapy through 180 days after the last dose if treated with pembrolizumab plus chemotherapy. Cohorts 1, 2a and b:

Reasons someone may not be able to joinExclusion criteria

Does not plan or is ineligible to receive pembrolizumab with or without chemotherapy per institutional standard/treating provider.
History of allogenic tissue/solid organ transplant. Cohort 2a and b Only:

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Moffitt Cancer CenterTampa, Florida
Our Lady of the Lake Physician's GroupBaton Rouge, Louisiana
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland
Sinai Hospital of BaltimoreBaltimore, Maryland
Medstar Franklin SquareBaltimore, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
TidalHealth Peninsula RegionalSalisbury, Maryland
Montefiore Medical Cancer CenterThe Bronx, New York
FirstHealth of the Carolinas, Inc.Pinehurst, North Carolina
Baptist Clinical Research InstituteMemphis, Tennessee
Nashville General HospitalNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Sep 21, 2026. Always confirm current availability with the study team.

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