Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms (Drugs-SNPs)

May 28, 2026 updated by: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair

Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer.

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The usual approach group, diagnosed metastatic ALK-positive NSCLC, 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, diagnosed metastatic ALK-positive NSCLC, 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.

Study Type

Interventional

Enrollment (Estimated)

600

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Doral, Florida, United States, 33172
        • Omnicure Clinical Research
    • Maryland
      • Rockville, Maryland, United States, 20853
        • Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

  • Select 600 patients with Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:

    • Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
    • Had no further NSCLC metastatic or growth in more than previous 90 days
  • 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 diagnosed metastatic ALK-positive NSCLC, 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 diagnosed metastatic ALK-positive NSCLC, like as the study approach group.

Inclusion Criteria:

  • 1. Metastatic ALK-Positive Non-Small Cell Lung Cancer (NSCLC) as follows:
  • Took ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily more than 90 days
  • Had no further NSCLC metastatic or growth in more than previous 90 days
  • 2. Suitable for enough blood-drawing
  • 3. Random and double blind
  • 4. Measurable disease
  • 5. Adequate organ functions
  • 6. Adequate performance status
  • 7. Age 24-64 years old
  • 8. Sign an informed consent form
  • 9. 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Alectinib - Usual

Usual Alectinib Chemotherapy (NDC...01)

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

Other Names:
  • Usual ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily
Experimental: 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
Drug: Alectinib - Study

Study Alectinib Chemotherapy (NDC...86)

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

Other Names:
  • Study ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated
Time Frame: Up to 12 weeks
  • Select 300 double blind random group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...01 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the usual approach group.
  • Select 300 double blind random group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...86 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the study approach group.
  • Measure above every NSCLC patient-specific Alectinib drug target (ALK) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
  • Report every NSCLC patient-specific ALK SNP genotype in whole genome DNA sequence.
Up to 12 weeks
Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated
Time Frame: Up to 12 weeks
  • Select 300 double blind random group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...01 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the usual approach group.
  • Select 300 double blind random group separated ALK-Positive Metastatic NSCLC patients currently using the Chemotherapy NDC...86 ALECENSA - alectinib 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, to be the study approach group.
  • Measure above every NSCLC patient-specific Alectinib drug target (CYP3A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
  • Report every NSCLC patient-specific CYP3A4 SNP genotype in whole genome DNA sequence.
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

UnitedHealthcare
Omnicure Clinical Research

Investigators

  • Study Chair: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
  • Study Director: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
  • Principal Investigator: Han Xu, MD/PhD/FAPCR, Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
  • Principal Investigator: Anneyd Avalos, M.D., Omnicure Clinical Research - Site 1
  • Principal Investigator: Felipe Gascon-Rondon, M.D., Omnicure Clinical Research - Site 2
  • Principal Investigator: Jeffrey Levy, M.D., Omnicure Clinical Research - Site 3
  • Principal Investigator: Ellie Soheili, M.D., Omnicure Clinical Research - Site 4
  • Principal Investigator: Marc E. Csete, M.D., Omnicure Clinical Research - Site 5

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2026

Primary Completion (Estimated)

November 18, 2026

Study Completion (Estimated)

December 28, 2026

Study Registration Dates

First Submitted

July 29, 2023

First Submitted That Met QC Criteria

August 4, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 28, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IND 168453 to be IND EXEMPT
  • FWA00015357 (Registry Identifier: HHS, Human Protections Administrator)
  • IORG0007849 (Registry Identifier: HHS, IORG)
  • IRB00009424 (Registry Identifier: HHS, IRB)
  • NPI - 1831468511 (Registry Identifier: HHS, Health Care Provider Individual)
  • NPI - 1023387701 (Registry Identifier: HHS, Health Care Provider Organization)
  • IND 168453 (Registry Identifier: FDA, IND EXEMPT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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