Clinical trial NCT05987956: Pharmacogenomics IND EXEMPT SNP Clinical Study - Alectinib and Single Nucleotide Polymorphisms
Official title: Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib 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
EGFR
NSCLC
SNP
Pharmacogenomics
Gene
Genetics
Lead sponsor: Medicine Invention Design, Inc
Sponsor class: INDUSTRY
Collaborators: name: UnitedHealthcare
First posted: 2023-08-14
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 (NDC...01)
* The study approach group (NDC...86)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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

Primary outcomes:
measure: Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and 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: PRINCIPAL_INVESTIGATOR
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: STUDY_CHAIR
References: