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

Study Overview
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Brief Summary
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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.

Detailed Description
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The usual approach group, after lung tissue biopsy, 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 lung tissue biopsy, 300 double blind random group separated NSCLC patients currently used the Chemotherapy on ALECENSA - alectinib hydrochloride capsule 450 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.

Official Title
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Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer.

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: Alectinib - Usual
* Drug: Alectinib - Study


Participation Criteria
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Eligibility Criteria
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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 High Dose 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 Low Dose on ALECENSA - alectinib hydrochloride capsule 450 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

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The usual approach group (high dose) The study approach group (low dose)
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alectinib - Usual<br>Usual ALECENSA - Alectinib Chemotherapy (high dose) Usual ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily Usual Approach Group (high dose) ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily | Drug: Alectinib - Usual<br>* Usual Alectinib Chemotherapy (high dose) - ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily<br>* Other names: Usual ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily;|
| Experimental: Alectinib - Study<br>Study ALECENSA - Alectinib Chemotherapy (low dose) Study ALECENSA - alectinib hydrochloride capsule 450 mg orally twice daily Study Approach Group (low dose) ALECENSA - alectinib hydrochloride capsule -- 450 mg orally twice daily | Drug: Alectinib - Study<br>* Study Alectinib Chemotherapy (low dose) - ALECENSA - alectinib hydrochloride capsule -- 450 mg orally twice daily<br>* Other names: Study ALECENSA - alectinib hydrochloride capsule 450 mg orally twice daily;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated. | Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy High Dose on ALECENSA - alectinib 600 mg orally twice daily, after lung tissue biopsy, to be the usual approach group. Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy Low Dose on ALECENSA - alectinib 450 mg orally twice daily, after lung tissue biopsy, to be the study approach group. Measure above every NSCLC patient-specific Alectinib drug target (ALK) SNP genotype in his or her NSCLC cell whole genome DNA with Oxford precisely sequencing. Report every NSCLC patient-specific ALK SNP genotype in whole genome DNA sequence. Measure above every NSCLC patient-specific Alectinib drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. Report every NSCLC patient-specific CYP4503A4 SNP genotype in whole genome DNA sequence. | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacogenomics, ALK, EGFR, NSCLC, SNP, Gene, Genetics