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

• Status: Not yet recruiting
• Trial end date: 2024-12-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
• Treatments: Alectinib

Criteria

• Select 600 Non-Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy

• Dosage Duration at least 90 days

• The usual approach group - Recruit 300 double blind random group separated NSCLC patients currently used the Chemotherapy NDC...01 on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, film coated after lung tissue biopsy, like as the usual approach group.

• The study approach group - Recruit 300 double blind random group separated NSCLC patients currently used the Chemotherapy NDC...86 on ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily, film coated after lung tissue biopsy, like as the study approach group.

Inclusion Criteria:

• 1. Clinical diagnosis of Non-Small Cell Lung Cancer (NSCLC)

• 2. Clinical lung tissue biopsy diagnosis of NSCLC

• 3. Suitable for enough lung tissue biopsy of NSCLC

• 4. Random and double blind

• 5. Measurable disease

• 6. Adequate organ functions

• 7. Adequate performance status

• 8. Age 22 years old and over

• 9. Sign an informed consent form

• 10. Receive blood-drawing

Exclusion Criteria:

• 1. Pneumonectomy

• 2. Treatment with other anti-cancer therapies and cannot be stopped currently

• 3. Pregnancy

• 4. Breast-feeding

• 5. The patients with other serious intercurrent illness or infectious diseases

• 6. Have more than one different kind of cancer at the same time

• 7. Serious Allergy to Drugs

• 8. Serious Bleed Tendency

• 9. Serious Risks or Serious Adverse Events of the drug product

• 10. The prohibition of drug products

• 11. Have no therapeutic effects

• 12. Follow up to the most current label