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

Phase 2

Not yet recruiting

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: Alectinib - Usual; Drug: Alectinib - Study

• Registration Number: NCT05987956
• Lead Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

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, 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.

Study Timeline

• Study First Submitted: 2023-07-29
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-09
• Last Update Posted: 2024-08-13
• Study Start: 2024-11-08
• Primary Completion: 2025-11-18
• Study Completion: 2025-12-28

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alectinib - Usual	Alectinib - Usual	* 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
Alectinib - Study	Alectinib - Study	* 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

Primary Outcome Measures

Name	Time	Method
Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.	Up to 12 weeks	* Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy NDC...01 on ALECENSA - alectinib 600 mg orally twice daily, after biopsy diagnosis, to be the usual approach group.; * Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy NDC...86 on ALECENSA - alectinib 600 mg orally twice daily, after biopsy diagnosis, 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 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.

Trial Locations

Locations (1)

Medicine Invention Design, Inc. - IORG0007849; 🇺🇸 Rockville, Maryland, United States