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

Phase 2

Not yet recruiting

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Crizotinib - Study; Drug: Crizotinib - Usual

• Registration Number: NCT06062810
• 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 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.

Detailed Description

The usual approach group, after lung tissue biopsy, 300 double blind random group separated NSCLC patients currently used the Combined Chemotherapy on XALKORI - crizotinib capsule, film coated, it will try to look for the relationship between the Crizotinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Crizotinib therapeutic safety and the CYP4503A SNP Genotyping, based on Oxford precisely sequencing drug targets' genes.

The study approach group, after lung tissue biopsy, 300 double blind random group separated NSCLC patients currently used the Combined Chemotherapy on XALKORI - crizotinib capsule, film coated, it will try to look for the relationship between the Crizotinib therapeutic efficacy and the ALK SNP Genotyping, and the relationship between the Crizotinib therapeutic safety and the CYP4503A 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: 2023-09-09
• Study First Submitted QC: 2023-09-25
• Study First Posted: 2023-10-02
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-13
• Last Update Posted: 2023-12-20
• Study Start: 2024-03-28
• Primary Completion: 2024-12-18
• Study Completion: 2024-12-28

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Crizotinib - Study	Crizotinib - Study	* XALKORI - Crizotinib * Chemotherapy * XALKORI - crizotinib capsule * XALKORI 200 mg taken orally twice daily * Usual Approach Group (low dose)
Crizotinib - Usual	Crizotinib - Usual	* XALKORI - Crizotinib * Chemotherapy * XALKORI - crizotinib capsule * XALKORI 250 mg taken orally twice daily * Usual Approach Group (high dose)

Primary Outcome Measures

Name	Time	Method
Measure and Report Crizotinib oncology drug target ALK SNP Genotypes which are effectiveness-associated.	Up to 12 weeks	* Recruit 300 double blind random group separated NSCLC patients currently using the Combined Chemotherapy High Dose on XALKORI - crizotinib (250mg orally twice daily), after lung tissue biopsy, to be the usual approach group.; * Recruit 300 double blind random group separated NSCLC patients currently using the Combined Chemotherapy Low Dose on XALKORI - crizotinib (200mg orally twice daily), after lung tissue biopsy, to be the study approach group.; * Measure above every NSCLC patient specific Crizotinib oncology drug target ALK SNP genotype in his or her NSCLC cell whole genome DNA with Oxford precisely sequencing.; * Report every NSCLC patient specific ALK SNP genotype in whole genome DNA sequence.
Measure and Report Crizotinib oncology drug target CYP4503A SNP Genotypes which are risk associated.	Up to 12 weeks	* Recruit 300 double blind random group separated NSCLC patients currently using the Combined Chemotherapy High Dose on XALKORI - crizotinib (250mg orally twice daily), after lung tissue biopsy, to be the usual approach group.; * Recruit 300 double blind random group separated NSCLC patients currently using the Combined Chemotherapy Low Dose on XALKORI - crizotinib (200mg orally twice daily), after lung tissue biopsy, to be the study approach group.; * Measure above every NSCLC patient specific Crizotinib oncology drug target CYP4503A SNP genotype in his/her WBC cell whole genome DNA with Oxford precisely sequencing.; * Report every NSCLC patient specific CYP4503A SNP genotype in whole genome DNA sequence.

Trial Locations

Locations (1)

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