Actively Recruiting
Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC
Led by H. Lee Moffitt Cancer Center and Research Institute · Updated on 2026-04-02
318
Participants Needed
5
Research Sites
237 weeks
Total Duration
On this page
Sponsors
H
H. Lee Moffitt Cancer Center and Research Institute
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing and able to provide written informed consent or assent
- At least 18 years old on the day of signing informed consent
- Self-identify as Black or African American
- ECOG performance status between 0 and 2
- Histologically or cytologically confirmed advanced or metastatic NSCLC
- Treatment naive in the advanced, metastatic, or recurrent disease setting
- No known EGFR, ALK, or ROS1 tumor mutations; liquid biopsy acceptable
- Eligible for first-line therapy in advanced/metastatic setting
- Have PD-L1 tissue testing status
- Recovered to Grade 1 or baseline from prior anticancer therapy adverse events, with some exceptions
- Adequate organ function
- Female participants of childbearing potential must have a negative pregnancy test within 72 hours before first study dose
- Female participants of childbearing potential must use two birth control methods, be surgically sterile, or abstain from heterosexual activity during study and specified follow-up periods
- Male participants must agree to use barrier contraception during study and specified follow-up periods
You will not qualify if you...
- Not planning or ineligible to receive pembrolizumab with or without chemotherapy
- History of allogenic tissue or solid organ transplant
- Prior chemotherapy or immune checkpoint inhibitor treatment for advanced/metastatic lung cancer (cohorts 2a and 2b)
- Diagnosis of immunodeficiency or on systemic steroid therapy ≥10 mg prednisone or other immunosuppressives at first dose
- Active autoimmune disease requiring systemic treatment in past 2 years, with some exceptions
- Active infection requiring systemic therapy
- Conditions or therapies that may interfere with study participation or increase adverse event risk
- Received live vaccine within 30 days before planned study therapy
- Use of investigational agent or device within 3 weeks prior to study intervention
- History of pneumonitis or interstitial lung disease requiring steroids, or current pneumonitis/ILD
- Untreated central nervous system metastases or carcinomatous meningitis
- Severe hypersensitivity to pembrolizumab or chemotherapy agents used in study (carboplatin, cisplatin, taxane, pemetrexed)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 5 locations
1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
2
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Actively Recruiting
3
TidalHealth Peninsula Regional
Salisbury, Maryland, United States, 20801
Actively Recruiting
4
Montefiore Medical Cancer Center
The Bronx, New York, United States, 10461
Actively Recruiting
5
Baptist Clinical Research Institute
Memphis, Tennessee, United States, 38120
Actively Recruiting
Research Team
A
Anahid Aminpour
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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