ALK-Positive Non-Small Cell Lung Cancer (NSCLC)
Conditions
Keywords
ALK, EGFR, NSCLC, SNP, Pharmacogenomics, Gene, Genetics
Brief 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.
Detailed description
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.
Interventions
DRUGALECENSA - alectinib hydrochloride capsule
* Usual Alectinib Chemotherapy (NDC...01) * ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily * Study Alectinib Chemotherapy (NDC...86) * ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
Sponsors
Han Xu, M.D., Ph.D., FAPCR, Medical Director,, IRB Chair
UnitedHealthcare
Omnicure Clinical Research
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Masking description
Open Label
Intervention model description
* The usual approach group (NDC...01) (Group 1) (Patient 1-300) * The study approach group (NDC...86) (Group 2) (Patient 301-600)
Eligibility
Sex/Gender
ALL
Age
24 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated | Up to 12 weeks | * 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. |
| Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated | Up to 12 weeks | * 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORHan Xu, MD/PhD/FAPCR
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
STUDY_DIRECTORHan Xu, MD/PhD/FAPCR
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
STUDY_CHAIRHan Xu, MD/PhD/FAPCR
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
PRINCIPAL_INVESTIGATORAnneyd Avalos, M.D.
Omnicure Clinical Research - Site 1
PRINCIPAL_INVESTIGATORFelipe Gascon-Rondon, M.D.
Omnicure Clinical Research - Site 2
PRINCIPAL_INVESTIGATORJeffrey Levy, M.D.
Omnicure Clinical Research - Site 3
PRINCIPAL_INVESTIGATOREllie Soheili, M.D.
Omnicure Clinical Research - Site 4
PRINCIPAL_INVESTIGATORMarc E. Csete, M.D.
Omnicure Clinical Research - Site 5
Outcome results
None listed