Pharmacogenomics IND EXEMPT SNP Clinical Study - Alectinib and Single Nucleotide Polymorphisms (Drugs-SNPs)

Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Status and phase: Begins enrollment in 4 months; Phase 3; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Alectinib - Study; Drug: Alectinib - Usual

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05987956

IRB00009424 (Registry Identifier)

IND 168453 (Registry Identifier)

FWA00015357 (Registry Identifier)

NPI - 1023387701 (Registry Identifier)

IORG0007849 (Registry Identifier)

NPI - 1831468511 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

The usual approach group, after biopsy diagnosis, 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 biopsy diagnosis, 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.

1. Detect drug target whole gene precision sequence of everyone patient for all 600 recruited double blind NSCLC patients.
2. Mutually compare everyone patient drug target whole gene precision sequence for a total of 600 recruited double blind NSCLC patients.
3. Calculate drug target gene SNPs in all 600 recruited double blind 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 double blind random group separated NSCLC patients) with the study approach group SNPs (300 double blind random 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 22 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Select 600 Non-Small Cell Lung Cancer Patients who are suitable for blood-drawing.
• 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 biopsy diagnosis, 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 biopsy diagnosis, like as the study approach group.

Inclusion Criteria:

• 1. Clinical diagnosis of Non-Small Cell Lung Cancer (NSCLC)
• 2. Clinical biopsy diagnosis of NSCLC
• 3. Suitable for enough blood-drawing
• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

600 participants in 2 patient groups

Alectinib - Usual

Experimental group

Description:

* Usual ALECENSA - Alectinib * Chemotherapy (NDC...01) * Usual ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily * Usual Approach Group (NDC...01) * ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

Treatment:

Drug: Alectinib - Usual

Alectinib - Study

Experimental group

Description:

* Study ALECENSA - Alectinib * Chemotherapy (NDC...86) * Study ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily * Study Approach Group (NDC...86) * ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

Treatment:

Drug: Alectinib - Study