Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

Phase 3Active Not RecruitingNCT05987956

Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair600 enrolled

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.

The usual approach group, diagnosed metastatic ALK-positive NSCLC, 300 Sequential Assignment 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 Sequential Assignment 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 Sequential Assignment NSCLC patients. 2. Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited Sequential Assignment NSCLC patients. 3. Calculate drug target gene SNPs in all 600 recruited Sequential Assignment 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 Sequential Assignment group separated NSCLC patients) with the study approach group SNPs (300 Sequential Assignment 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.

Study Type

INTERVENTIONAL

Allocation

Eligibility

Sex: ALLMin age: 24 YearsMax age: 64 Years

Medical Language ↔ Plain English

* 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 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy NDC...01 on ALECENSA capsule 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, like as the usual approach group. * The study approach group - Recruit 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy NDC...86 on ALECENSA capsule 600 mg orally twice daily, 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\. Sequential Assignment * 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

Outcomes

Primary Outcomes

Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated

* Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...01 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the usual approach group. * Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...86 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the study approach group. * Measure above every NSCLC patient-specific Alectinib drug target (ALK) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every NSCLC patient-specific ALK SNP genotype in whole genome DNA sequence.

Time frame: Up to 12 weeks

Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated

* Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...01 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the usual approach group. * Select 300 Sequential Assignment group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...86 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the study approach group. * Measure above every NSCLC patient-specific Alectinib drug target (CYP3A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every NSCLC patient-specific CYP3A4 SNP genotype in whole genome DNA sequence.

Time frame: Up to 12 weeks

Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

Overview

Conditions

Interventions

Eligibility

Locations (2)

Outcomes

Primary Outcomes