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NCT05987956Active, not recruitingPhase 2/3

Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

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

Source: ClinicalTrials.gov · Last updated 8 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
600 (estimated)
First submitted
29 Jul 2023
Start date
18 Mar 2026
Primary completion date
18 Nov 2026
Lead sponsor
Medicine Invention Design, Inc
Diseases
Lung cancer
NCT number
NCT05987956

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 600
  • From 18 Mar 2026 to the primary completion date, 18 Nov 2026
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 2\. Treatment with other anti-cancer therapies and cannot be stopped currently
  • 9\. Serious Risks or Serious Adverse Events of the drug product
  • 10\. The prohibition of drug products

Other illness

  • 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

Other

  • 1\. Pneumonectomy
  • 3\. Pregnancy
  • 4\. Breast-feeding
  • 8\. Serious Bleed Tendency
  • 11\. Have no therapeutic effects
  • 12\. Follow up to the most current label

Who the study is looking for

  • 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

Criteria the registry did not label

  • 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.

Age in the registry: 24 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Omnicure Clinical Research
Coordinator of this site? Confirm its status
DoralUnited StatesUnknown status
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701
Coordinator of this site? Confirm its status
RockvilleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.