Study on Crizotinib and Genetic Variations in Non-Small Cell Lung Cancer Patients

Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Sponsor score: 0

ClinicalTrials ID:NCT06062810

Provider View

This clinical trial is investigating how genetic differences in certain genes might affect the effectiveness and side effects of the drug Crizotinib in patients with non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The study aims to understand how variations in specific genes, known as single nucleotide polymorphisms (SNPs), influence the effectiveness and side effects of Crizotinib, a medication used to treat non-small cell lung cancer (NSCLC). Researchers will analyze the genetic makeup of patients to see if these genetic differences impact how well the drug works and its safety profile.

Description

In this study, researchers will examine the genetic differences in patients with non-small cell lung cancer (NSCLC) to see how these differences affect the treatment with Crizotinib. The study involves 600 patients who will be randomly divided into two groups. Each patient will undergo a lung tissue biopsy to collect samples for genetic analysis. The goal is to identify specific genetic variations, called single nucleotide polymorphisms (SNPs), in two genes: ALK and CYP4503A.

The ALK gene variations will be studied to see how they affect the drug's effectiveness, while the CYP4503A gene variations will be analyzed to understand their impact on the drug's side effects. By comparing the genetic data from all participants, researchers hope to confirm the relationship between these genetic variations and the drug's performance and safety. This information could help tailor treatments to individual patients based on their genetic profile, potentially improving outcomes and reducing side effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Non-Small Cell Lung Cancer (NSCLC)
  • Have had a lung tissue biopsy confirming NSCLC
  • Able to provide enough lung tissue for biopsy
  • Participation is random and double-blind
  • Have measurable disease
  • Have adequate organ function
  • Have a good overall health status
  • Aged 22 years or older
  • Willing to sign an informed consent form
  • Agree to have blood drawn for the study

Exclusion Criteria

  • Have had a lung removed (pneumonectomy)
  • Currently receiving other cancer treatments that cannot be stopped
  • Pregnant or breastfeeding
  • Have other serious illnesses or infections
  • Have more than one type of cancer at the same time
  • Have severe drug allergies
  • Have a tendency to bleed easily
  • Have serious risks or adverse reactions to the drug
  • Are prohibited from using the drug
  • Have not responded to the drug
  • Must follow the most current drug guidelines

Locations

FACILITYZIPCITYSTATE
Medicine Invention Design, Inc. - IORG000784920853RockvilleMaryland

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