Study on Real World Outcomes of Pembrolizumab in Black Patients with Advanced Non-Small Cell Lung Cancer (NSCLC)
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials ID:NCT06745882
This study is focused on understanding how Black patients with advanced non-small cell lung cancer (NSCLC) respond to the treatment pembrolizumab, with or without chemotherapy. It aims to gather real-world data on the effectiveness and safety of this treatment in patients who do not have certain genetic mutations.
Patient Parameters
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Program Overview
This clinical trial is designed to evaluate the outcomes of Black patients with advanced or metastatic non-small cell lung cancer (NSCLC) who are treated with pembrolizumab, a type of immunotherapy. The study includes patients who are 18 years or older, have a good performance status, and do not have specific genetic mutations (EGFR, ALK, ROS1) in their tumors. The goal is to collect real-world data on how well the treatment works and its safety in this patient group.
Eligibility Criteria
Inclusion Criteria
- Be willing and able to provide written consent to participate.
- Be 18 years or older.
- Identify as Black or African American.
- Have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
- Have a confirmed diagnosis of advanced or metastatic non-small cell lung cancer (NSCLC).
- Not have received treatment for advanced/metastatic/recurrent NSCLC before.
- Have no known mutations in EGFR, ALK, or ROS1 genes.
- Be eligible to receive first-line therapy for advanced/metastatic NSCLC.
- Have a test result for PDL1 status.
- Have recovered from any side effects of previous cancer treatments to a mild level or baseline.
- Have adequate organ function as determined by medical tests.
- Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective birth control during the study and for a specified period after.
- Men must agree to use barrier contraception during the study and for a specified period after.
Exclusion Criteria
- Not planning or eligible to receive pembrolizumab with or without chemotherapy.
- History of organ transplant.
- Have received prior chemotherapy or immune therapy for advanced/metastatic lung cancer.
- Have an immune deficiency or are on high-dose steroids or other immunosuppressive therapy.
- Have an active autoimmune disease requiring treatment in the past two years.
- Have an active infection needing treatment.
- Have any condition or treatment that could interfere with the study or increase risk.
- Have received a live vaccine within 30 days before starting the study.
- Have a history of severe lung inflammation or current lung disease.
- Have untreated brain metastases or cancer in the brain lining.
- Have severe allergies to pembrolizumab or related drugs.
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