Clinical trial NCT06062810: Pharmacogenomics IND EXEMPT SNP Clinical Study - Crizotinib and Single Nucleotide Polymorphisms
Official title: Explore the Relationship Between Single Nucleotide Polymorphisms and Crizotinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: ALK
ROS1
EGFR
SNP
Pharmacogenomics
Gene
Genetics
Lead sponsor: Medicine Invention Design, Inc
Sponsor class: INDUSTRY
First posted: 2023-10-02
Enrollment: 600
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: * The usual approach group (high dose)
* The study approach group (low dose)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Measure and Report Crizotinib oncology drug target ALK SNP Genotypes which are effectiveness-associated.
timeFrame: Up to 12 weeks
measure: Measure and Report Crizotinib oncology drug target CYP4503A SNP Genotypes which are risk associated.
timeFrame: Up to 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rockville
country: United States
facility: Medicine Invention Design, Inc. - IORG0007849
state: Maryland
Study officials:
affiliation: Medicine Invention Design, Inc. - IORG0007849
name: Han Xu, MD/PhD/FAPCR
role: STUDY_CHAIR
affiliation: Medicine Invention Design, Inc. - IORG0007849
name: Han Xu, MD/PhD/FAPCR
role: STUDY_DIRECTOR
affiliation: Medicine Invention Design, Inc. - IORG0007849
name: Han Xu, MD/PhD/FAPCR
role: PRINCIPAL_INVESTIGATOR
References: