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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-08

Study Completion Date

2026-12-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* The usual approach group (NDC...01)
* The study approach group (NDC...86)

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

No-placebo and random and double blind

Study Groups

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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

Group Type EXPERIMENTAL

Alectinib - Usual

Intervention Type DRUG

Usual Alectinib Chemotherapy (NDC...01)

\- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

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

Group Type EXPERIMENTAL

Alectinib - Study

Intervention Type DRUG

Study Alectinib Chemotherapy (NDC...86)

\- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

Interventions

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Alectinib - Usual

Usual Alectinib Chemotherapy (NDC...01)

\- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

Intervention Type DRUG

Alectinib - Study

Study Alectinib Chemotherapy (NDC...86)

\- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

Intervention Type DRUG

Other Intervention Names

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Usual ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily Study ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily

Eligibility Criteria

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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

Minimum Eligible Age

22 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

M.D., Ph.D., Sponsor-Investigator, Medical Director, Medical Monitor, Safety Officer, IRB Chair

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Han Xu, MD/PhD/FAPCR

Role: PRINCIPAL_INVESTIGATOR

Medicine Invention Design, Inc. - IORG0007849

Han Xu, MD/PhD/FAPCR

Role: STUDY_DIRECTOR

Medicine Invention Design, Inc. - IORG0007849

Han Xu, MD/PhD/FAPCR

Role: STUDY_CHAIR

Medicine Invention Design, Inc. - IORG0007849

Locations

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Medicine Invention Design, Inc. - IORG0007849

Rockville, Maryland, United States

Site Status

Countries

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United States

Central Contacts

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Han Xu, MD/PhD/FAPCR

Role: CONTACT

[email protected]

301-222-7143

Han Xu, MD/PhD/FAPCR

Role: CONTACT

[email protected]

301-326-8978

Facility Contacts

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Han Xu, MD/PhD/FAPCR

Role: primary

[email protected]

301-222-7143

HAN XU, MD/PhD/FAPCR

Role: backup

[email protected]

301-326-8978

Provided Documents

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