Study on How Genetic Differences Affect Alectinib Treatment in Non-Small Cell Lung Cancer

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

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05987956

Provider View

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

Patient Parameters

Program Overview

The study aims to understand if specific genetic differences in the ALK and CYP4503A4 genes affect how well Alectinib works and what side effects it might cause in patients with non-small cell lung cancer (NSCLC). Researchers will use precise genetic sequencing to explore these relationships.

Description

In this study, 600 patients with non-small cell lung cancer (NSCLC) will participate. They will be divided into two groups of 300 patients each. All participants will take Alectinib, a medication used to treat NSCLC, at a dose of 600 mg twice daily. The study will investigate how genetic differences, known as single nucleotide polymorphisms (SNPs), in the ALK and CYP4503A4 genes might influence the drug's effectiveness and safety.

The process involves:

  1. Sequencing the entire gene of interest for each patient to identify genetic differences.
  2. Comparing these genetic sequences among all 600 patients.
  3. Identifying specific genetic variations (SNPs) in the patients.
  4. Examining how these genetic variations relate to how well the drug works for each patient.
  5. Examining how these genetic variations relate to the safety and side effects of the drug for each patient.
  6. Comparing the genetic variations between the two groups of patients.
  7. Confirming the relationship between genetic variations and the drug's effectiveness.
  8. Confirming the relationship between genetic variations and the drug's safety.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with Non-Small Cell Lung Cancer (NSCLC).
  • Confirmed diagnosis through a biopsy.
  • Able to provide a blood sample.
  • Participation is random and double-blind.
  • Have measurable disease.
  • Have adequate organ function.
  • Be in good overall health.
  • Aged 22 years or older.
  • Willing to sign an informed consent form.
  • Agree to provide a blood sample.

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.
  • Cannot use the drug due to restrictions.
  • Have no therapeutic effects from the drug.
  • Must follow the most current drug guidelines.

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