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

NCT05987956 | Active Not Recruiting Phase 2 DMC FDA Drug

• 7 other identifiers: IND 168453 to be IND EXEMPTFWA00015357NPI - 1831468511NPI - 1023387701IRB00009424IORG0007849IND 168453
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

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.

Conditions

Non-small Cell Lung Cancer

Keywords

ALK; EGFR; NSCLC; SNP; Pharmacogenomics; Gene; Genetics

Outcome Measures

Primary Outcomes (1)

• Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.

  * Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy NDC...01 on ALECENSA - alectinib 600 mg orally twice daily, after biopsy diagnosis, to be the usual approach group. * Recruit 300 double blind random group separated NSCLC patients currently using the Chemotherapy NDC...86 on ALECENSA - alectinib 600 mg orally twice daily, after biopsy diagnosis, 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. * Measure above every NSCLC patient-specific Alectinib drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing. * Report every NSCLC patient-specific CYP4503A4 SNP genotype in whole genome DNA sequence.

  Up to 12 weeks

Study Arms (2)

Alectinib - Usual

EXPERIMENTAL

* 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

Alectinib - Study

EXPERIMENTAL

* 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

Interventions

Alectinib - Usual DRUG

Usual Alectinib Chemotherapy (NDC...01) \- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

Also known as: Usual ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily

Alectinib - Usual

Alectinib - Study DRUG

Study Alectinib Chemotherapy (NDC...86) \- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

Also known as: Study ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily

Alectinib - Study

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Clinical diagnosis of Non-Small Cell Lung Cancer (NSCLC)
• \. Clinical biopsy diagnosis of NSCLC
• \. Suitable for enough blood-drawing
• \. Random and double blind
• \. Measurable disease
• \. Adequate organ functions
• \. Adequate performance status
• \. Age 22 years old and over
• \. Sign an informed consent form
• \. Receive blood-drawing

You may not qualify if:

• \. Pneumonectomy
• \. Treatment with other anti-cancer therapies and cannot be stopped currently
• \. Pregnancy
• \. Breast-feeding
• \. The patients with other serious intercurrent illness or infectious diseases
• \. Have more than one different kind of cancer at the same time
• \. Serious Allergy to Drugs
• \. Serious Bleed Tendency
• \. Serious Risks or Serious Adverse Events of the drug product
• \. The prohibition of drug products
• \. Have no therapeutic effects
• \. Follow up to the most current label

Sponsors & Collaborators

• Omnicure Clinical Research: collaborator
• UnitedHealthcare: collaborator
• Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair: lead

Study Sites (2)

Omnicure Clinical Research

Doral, Florida, 33172, United States

Location

Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

Rockville, Maryland, 20853, United States

Location

Related Links

• FWA \< 00015357 \> \< Medicine Invention Design Incorporation (MIDI) \>
• IRB \< 00009424 \> \< Medicine Invention Design Incorporation (MIDI) \>
• IORG \< 0007849 \> \< Medicine Invention Design Incorporation (MIDI) \>

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• 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

  STUDY DIRECTOR

• Han Xu, MD/PhD/FAPCR

  Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701

  STUDY CHAIR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: No-placebo and random and double blind
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D., Sponsor-Investigator, Medical Director, Medical Monitor, Safety Officer, IRB Chair

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

Study Record Dates

• First Submitted: July 29, 2023
• First Posted: August 14, 2023
• Study Start: March 18, 2026
• Primary Completion (Estimated): November 18, 2026
• Study Completion (Estimated): December 28, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)