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

• Status: Not yet recruiting
• Trial end date: 2024-12-28
• Target enrollment: 0
• Participant gender: All

Summary

Explore the relationship between drug target ALK gene single nucleotide polymorphisms and XALKORI - Crizotinib therapeutic-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

Explore the relationship between drug target CYP4503A gene single nucleotide polymorphisms and XALKORI - Crizotinib side-effects in patients with non-small cell lung cancer, based on Oxford precisely sequencing drug targets' genes.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
• Treatments: Crizotinib

Criteria

• 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 Combined Chemotherapy High Dose on XALKORI - crizotinib capsule, 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 Combined Chemotherapy Low Dose on XALKORI - crizotinib capsule, 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