Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

The usual approach group, diagnosed metastatic ALK-positive NSCLC, 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, diagnosed metastatic ALK-positive NSCLC, 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.

• Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind NSCLC patients.
• Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind NSCLC patients.
• Calculate drug target gene SNPs in all 600 recruited double blind NSCLC patients.
• Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
• Correlate everyone patient drug target gene SNP to everyone patient drug safety.
• 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).
• Confirm the relationship between drug target gene SNPs and drug efficacy.
• Confirm the relationship between drug target gene SNPs and drug safety.

• Select 600 patients with Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:

• Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
• Had no further NSCLC metastatic or growth in more than previous 90 days
• 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 diagnosed metastatic ALK-positive NSCLC, 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 diagnosed metastatic ALK-positive NSCLC, like as the study approach group.

Inclusion criteria

• 1. Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:
• Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
• Had no further NSCLC metastatic or growth in more than previous 90 days
• 2. Suitable for enough blood-drawing
• 3. Random and double blind
• 4. Measurable disease
• 5. Adequate organ functions
• 6. Adequate performance status
• 7. Age 24-64 years old
• 8. Sign an informed consent form
• 9. 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