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Non-small Cell Lung CancerPhase 2NCT06745882

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

A Phase 2 study testing Cisplatin, Carboplatin and Pemetrexed in people with Non-small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
Cisplatin, Carboplatin and Pemetrexed
Could I receive a placebo?
No, everyone receives an active treatment
How many people
318 participants
Where
11 sitesUnited States
Study dates
13 Jun 2025to Jan 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 32Show fewer
  • 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: Exclusion 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: Exclusion Criteria:
  • Received prior treatment chemotherapy and/or immune checkpoint inhibitor therapy in the advanced/metastatic setting for lung cancer.
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at doses
  • ≥ 10 mg prednisone or any other form of systemic immunosuppressive therapy at C1D1. Subjects are permitted to use topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Physiologic replacement doses of systemic corticosteroids are permitted (i.e., ≤ 10 mg/day prednisone equivalents). A brief course (≤ 7 days) of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by contact allergen) is permitted.
  • Has active autoimmune disease that has required active systemic treatment in the past 2 years [i.e., with use of disease modifying agents, corticosteroids in doses greater than 10 mg of prednisone daily (or equivalent) or immunosuppressive drugs]. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, that would substantially increase the risk of incurring adverse events (AEs) from the study medications, that would interfere with the subject's participation for the full duration of the study or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has received a live vaccine within 30 days of planned start of study therapy.
  • Cohorts 1, 2a and b: Exclusion Criteria:
  • Has received an investigational agent or has used an investigational device within 3 weeks prior to study intervention administration.
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has known untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they have completed radiation therapy (where applicable), are clinically stable and have not required steroid treatment at ≥ 10 mg of prednisone for at least 3 days prior to the first dose of study intervention.
  • Severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients or has a known sensitivity as applicable to carboplatin, cisplatin, taxane or pemetrexed.

Who cannot join

None listed.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Anahid Aminpour contact

813-745-0287

anahid.aminpour@moffitt.org

11 sites in 1 country

United States11 sites, 11 recruiting

  • University of Maryland Greenebaum Cancer Center

    Baltimore, Maryland, 21201

    Katherine Scilla, MD

    Recruiting

  • Sinai Hospital of Baltimore

    Baltimore, Maryland, 21215

    Vishal Jindal, MD

    Recruiting

  • Medstar Franklin Square

    Baltimore, Maryland, 21237

    Brian Ramnaraign, MD

    Recruiting

  • Johns Hopkins Sidney Kimmel Comprehensive Cancer Center

    Baltimore, Maryland, 21287

    Julie Brahmer, MD

    Recruiting

  • Our Lady of the Lake Physician's Group

    Baton Rouge, Louisiana, 70805

    Marshall Stagg, MD

    Recruiting

  • Baptist Clinical Research Institute

    Memphis, Tennessee, 38120

    Osarenren Ogbeide, MD

    Recruiting

  • Nashville General Hospital

    Nashville, Tennessee, 37208

    Robin Jacob, MD

    Recruiting

  • FirstHealth of the Carolinas, Inc.

    Pinehurst, North Carolina, 28374

    Charles Kuzma, MD

    Recruiting

  • TidalHealth Peninsula Regional

    Salisbury, Maryland, 20801

    Milcah Larks, MD

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Jhanelle Gray, MD

    Tiffany Apana, MSN, FNP-BC

    Recruiting

  • Montefiore Medical Cancer Center

    The Bronx, New York, 10461

    Balazs Halmos, MD

    Recruiting

Other trials in United States

About this study

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

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.

Keywords
Justice
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CisplatinDrug

    Given on day 1 of every 21-day cycle.

  • CarboplatinDrug

    Given on day 1 of every 21-day cycle.

  • PemetrexedDrug

    Given on day 1 of every 21-day cycle.

  • PembrolizumabDrug

    Given on day 1 of every 21-day cycle. After cycle 4 is given every 6 weeks.

  • AbraxaneDrug

    Given on days 1, 8, and 15 of each 21-day cycle.

  • PaclitaxelDrug

    Given on day 1 of every 21-day cycle.

Study groups in NCT06745882
Study groupRoleWhat they receive
Cohort 1ExperimentalNon-interventional prospective cohort and participants will receive standard of care pembrolizumab with or without chemotherapy.
Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Pembrolizumab; Drug: Abraxane; Drug: Paclitaxel
Cohort 2: arm AExperimentalCohort 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.
Receives: Drug: Pembrolizumab
Cohort 2: arm BExperimentalCohort 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.
Receives: Drug: Cisplatin; Drug: Carboplatin; Drug: Pemetrexed; Drug: Pembrolizumab; Drug: Abraxane; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cohort 1: Real World Overall Survival (rwOS)

    Real-world overall survival (rwOS) is defined as the length of time from the date the patient initiates treatment to the date of death or end of follow up, whichever occurred earliest.

    Measured: Up to 36 Months

  2. Cohort 2 Arm A: Progression Free Survival (PFS)

    Progression free survival is defined as the length of time from date of patient starts treatment to date of progression event or death.

    Measured: Up to 36 Months

  3. Cohort 2 Arm B: Progression Free Survival (PFS)

    Progression free survival is defined as the length of time from date of patient starts treatment to date of progression event or death.

    Measured: Up to 36 Months

Secondary outcomes (3)

  1. Cohort 1: Baseline ctDNA

    Baseline ctDNA will be summarized by mean, median, minimum, maximum, standard deviation, and coefficient of variation.

    Measured: At Baseline

  2. Cohort 2: Arm A and Arm B Objective Response Rate (ORR)

    Objective response rate will be determined by summing the rates of complete response and partial response.

    Measured: Up to 36 Months

  3. Cohort 2: Arm A and Arm B Overall Survival (OS)

    Overall Survival is defined as the length of time from the date the patient initiates treatment to the date of death or end of follow up, whichever occurred earliest.

    Measured: Up to 36 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start13 Jun 2025
  3. Primary completionJan 2030 (estimated)
  4. Study completionJan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
318 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06745882
Sponsor's protocol ID
MCC-21630
Status last verified
Sep 2026
First submitted
17 Dec 2024
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cisplatin, Carboplatin and Pemetrexed in people with Non-small Cell Lung Cancer, run by H. Lee Moffitt Cancer Center and Research Institute at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 32 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Anahid Aminpour (813-745-0287, anahid.aminpour@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cohort 1: Real World Overall Survival (rwOS) (time frame: Up to 36 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06745882.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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