Pharmacogenomics IND EXEMPT SNP Clinical Study - Alectinib and Single Nucleotide Polymorphisms

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

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05987956

Patient View

This study investigates the link between ALK and CYP4503A4 gene SNPs and the efficacy and safety of Alectinib in 600 NSCLC patients. Participants, aged 22+, undergo precise gene sequencing and are divided into two double-blind groups, each receiving 600 mg Alectinib twice daily. Eligibility includes a biopsy-confirmed NSCLC diagnosis, adequate organ function, and informed consent.

Patient Parameters

Program Overview

Explore the relationship between drug target ALK gene single nucleotide polymorphisms and ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms and ALECENSA - Alectinib side-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Description

The usual approach group, after biopsy diagnosis, 300 double blind random group separated NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, it will try to look for the relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Alectinib therapeutic safety and the CYP4503A SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

The study approach group, after biopsy diagnosis, 300 double blind random group separated NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, it will try to look for the relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Alectinib therapeutic safety and the CYP4503A4 SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

  1. Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind NSCLC patients.
  2. Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind NSCLC patients.
  3. Calculate drug target gene SNPs in all 600 recruited double blind NSCLC patients.
  4. Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
  5. Correlate everyone patient drug target gene SNP to everyone patient drug safety.
  6. Mutually compare the usual approach group SNPs (300 double blind random group separated NSCLC patients) with the study approach group SNPs (300 double blind random group separated NSCLC patients).
  7. Confirm the relationship between drug target gene SNPs and drug efficacy.
  8. Confirm the relationship between drug target gene SNPs and drug safety.

Eligibility Criteria

Inclusion Criteria

    1. Clinical diagnosis of Non-Small Cell Lung Cancer (NSCLC)
    1. Clinical biopsy diagnosis of NSCLC
    1. Suitable for enough blood-drawing
    1. Random and double blind
    1. Measurable disease
    1. Adequate organ functions
    1. Adequate performance status
    1. Age 22 years old and over
    1. Sign an informed consent form
    1. Receive blood-drawing

Exclusion Criteria

    1. Pneumonectomy
    1. Treatment with other anti-cancer therapies and cannot be stopped currently
    1. Pregnancy
    1. Breast-feeding
    1. The patients with other serious intercurrent illness or infectious diseases
    1. Have more than one different kind of cancer at the same time
    1. Serious Allergy to Drugs
    1. Serious Bleed Tendency
    1. Serious Risks or Serious Adverse Events of the drug product
    1. The prohibition of drug products
    1. Have no therapeutic effects
    1. Follow up to the most current label

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