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

NCT05987956 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • ALK-Positive Non-Small Cell Lung Cancer (NSCLC)

Interventions

DRUG

Alectinib - Usual

Usual Alectinib Chemotherapy (NDC...01) \- 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

Sponsors & Collaborators

  • UnitedHealthcare

    collaborator OTHER

  • Omnicure Clinical Research

    collaborator UNKNOWN

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

    lead INDUSTRY

Principal Investigators

  • Han Xu, MD/PhD/FAPCR · Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

  • Han Xu, MD/PhD/FAPCR · Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

  • Han Xu, MD/PhD/FAPCR · Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

  • Anneyd Avalos, M.D. · Omnicure Clinical Research - Site 1

  • Felipe Gascon-Rondon, M.D. · Omnicure Clinical Research - Site 2

  • Jeffrey Levy, M.D. · Omnicure Clinical Research - Site 3

  • Ellie Soheili, M.D. · Omnicure Clinical Research - Site 4

  • Marc E. Csete, M.D. · Omnicure Clinical Research - Site 5

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-18
Primary Completion
2026-11-18
Completion
2026-12-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05987956 on ClinicalTrials.gov