Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC
Prospective Trial to Assess Real-world Outcomes and Predictive Biomarkers of Response to Pembrolizumab With or Without Chemotherapy in Black Patients With NSCLC
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how well pembrolizumab works in routine care, with or without chemotherapy. It is for Black adults with advanced non-small cell lung cancer (NSCLC) and no known EGFR, ALK, or ROS1 tumor gene changes.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Identify as Black or African American, be age 18 or older, and agree in writing to join.
- Have advanced NSCLC confirmed by a tissue or cell test. The cancer may have spread to other parts of the body.
- Be able to care for yourself and be up and about at least half of your waking hours (ECOG score 0–2). Your organs must work well enough.
- Have no known EGFR, ALK, or ROS1 tumor gene changes. Blood-based tumor tests are allowed. Your PD-L1 tissue testing status must be available.
- Be eligible and planned for first treatment for advanced cancer. Earlier treatment for less advanced cancer is allowed if the cancer returned at least 6 months after treatment ended.
- Side effects from past cancer treatment must be mild or back to your usual level. Treated hormone problems and some nerve damage are allowed.
- If you could become pregnant, have a negative pregnancy test within 72 hours before treatment. Use two birth control methods or avoid sex that could cause pregnancy during treatment and for 180 days after combined treatment, or 120 days after pembrolizumab alone.
- Men receiving pembrolizumab with chemotherapy must use barrier birth control during treatment and for 180 days after the last dose.
Who can't join
- All groups: You cannot receive, or do not plan to receive, pembrolizumab with or without chemotherapy, or have had a tissue or solid organ transplant from another person.
- All groups: You used an experimental drug or device within 3 weeks before study treatment.
- All groups: You have lung inflammation or lung tissue disease now, or had a noninfectious form that needed steroids.
- All groups: You have untreated cancer spread to the brain or spinal cord, or cancer in their lining. Treated brain spread may be allowed if radiation is finished, your condition is stable, and you meet steroid limits.
- All groups: You have a severe allergy to pembrolizumab or its ingredients, or a known allergy to the listed chemotherapy drugs.
- Groups 2a and 2b only: You already had chemotherapy or immune checkpoint treatment for advanced lung cancer, have a weakened immune system, or take certain immune-suppressing medicines. Some steroid uses are allowed.
- Groups 2a and 2b only: You have an active disease in which the immune system attacks the body that needed whole-body treatment in the past 2 years. Some conditions and hormone replacement treatments are allowed.
- Groups 2a and 2b only: You have an infection needing whole-body treatment, received a live vaccine within 30 days before treatment, or have another health issue that the study doctor thinks makes joining unsafe or could affect the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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 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.
Study sites (11)
FL
- Moffitt Cancer Center · Tampa, FL 33612Jhanelle Gray, MD · Principal investigatorTiffany Apana, MSN, FNP-BC · Sub-investigatorAlberto Chiappori, MD · Sub-investigatorBenjamin Creelan, MD · Sub-investigatorMore trials in Tampa
LA
- Our Lady of the Lake Physician's Group · Baton Rouge, LA 70805Marshall Stagg, MD · Principal investigatorMore trials in Baton Rouge
MD
- University of Maryland Greenebaum Cancer Center · Baltimore, MD 21201Katherine Scilla, MD · Principal investigatorMore trials in Baltimore
- Sinai Hospital of Baltimore · Baltimore, MD 21215Vishal Jindal, MD · Principal investigatorMore trials in Baltimore
- Medstar Franklin Square · Baltimore, MD 21237Brian Ramnaraign, MD · Principal investigatorMore trials in Baltimore
- Johns Hopkins Sidney Kimmel Comprehensive Cancer Center · Baltimore, MD 21287Julie Brahmer, MD · Principal investigatorMore trials in Baltimore
- TidalHealth Peninsula Regional · Salisbury, MD 20801Milcah Larks, MD · Principal investigatorMore trials in Salisbury
NC
- FirstHealth of the Carolinas, Inc. · Pinehurst, NC 28374Charles Kuzma, MD · Principal investigatorMore trials in Pinehurst
NY
- Montefiore Medical Cancer Center · The Bronx, NY 10461Balazs Halmos, MD · Principal investigatorMore trials in The Bronx
TN
- Baptist Clinical Research Institute · Memphis, TN 38120Osarenren Ogbeide, MD · Principal investigatorMore trials in Memphis
- Nashville General Hospital · Nashville, TN 37208Robin Jacob, MD · Principal investigatorMore trials in Nashville