Active Not RecruitingPhase 2 / Phase 3NCT05987956
Official study title

Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

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.

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Key things to know

Main goalHealth Services Research

This describes the study’s primary purpose.

What is being studiedALECENSA - alectinib hydrochloride capsule

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · ALK

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 8, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Active Not Recruiting

The study is underway but is not accepting new participants.

What kind of study?Phase 2 / Phase 3

Interventional

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?Medicine Invention Design, Inc

Study sponsor

01
Study overview

What this study is about

Purpose
Health Services Research
Study type
Interventional
Phase
Phase 2 / Phase 3
Sponsor
Medicine Invention Design, Inc
Interventions being studied
Drug: ALECENSA - alectinib hydrochloride capsule
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy NDC...01 on ALECENSA capsule 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, like as the usual approach group.
  • The study approach group - Recruit 300 Sequential Assignment group separated NSCLC patients currently used the Chemotherapy NDC...86 on ALECENSA capsule 600 mg orally twice daily, diagnosed metastatic ALK-positive NSCLC, like as the study approach group.
  • 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\. Sequential Assignment
  • 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
Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Omnicure Clinical ResearchDoral, Florida
  • Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701Rockville, Maryland

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 8, 2026. Always confirm current availability with the study team.

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