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

Sponsor score: 40
Inactive

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

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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