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New treatment option for Non-small Cell Lung Cancer
Official title Prospective Trial Assessing Real World Outcomes Response to Pembro in Black Patients w/ NSCLC
ClinicalTrials.gov ID: NCT06745882
What this study is testing
What is Cisplatin?
Cisplatin is an investigational medicine, being studied as a potential treatment for non-small cell lung cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Has active autoimmune disease that has required active systemic treatment in the past 2 years [i.e., with use of disease modifying agents...
- people are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring...
See the full eligibility 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...
- 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...
- Adequate organ function.
- Female people 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...
- Female people 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...
- Male people 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...
- 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. people are permitted to use topical, ocular...
- 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)...
- people 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
- Baltimore, Maryland, United States
- Salisbury, Maryland, United States
- The Bronx, New York, United States
- Memphis, Tennessee, United States
- Nashville, Tennessee, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States; Baltimore, Maryland, United States; Salisbury, Maryland, United States; The Bronx, New York, United States; Memphis, Tennessee, United States; Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.