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Clinical Trials in the USA / NCT05987956
Active, not recruiting Phase 2/3

Pharmacogenomics IND SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms

NCT05987956 · tracked via the Priya Life Science USA tracker
Sponsor
Medicine Invention Design, Inc
Phase
Phase 2/3
Started
2026-03-18
Last updated
2026-10-08

Condition(s) studied

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

Investigational drug(s) / intervention(s)

ALECENSA - alectinib hydrochloride capsule

ALECENSA - alectinib hydrochloride capsule: * Usual Alectinib Chemotherapy (NDC...01) * ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily * Study Alectinib Chemotherapy (NDC...86) * ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily

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.

Eligibility

Sex
ALL
Min age
24 Years
Max age
64 Years
Healthy volunteers
No
* 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. 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\. 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 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

Primary outcome measure(s)

  • Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated — Up to 12 weeks
    * Select 300 Sequential Assignment 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 Sequential Assignment 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.
  • Measure and Report Alectinib Drug Targets' SNP Genotypes which are risk-associated — Up to 12 weeks
    * Select 300 Sequential Assignment 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 Sequential Assignment 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.

Trial sites (2)

FacilityCityRegionStatus
Omnicure Clinical Research Doral Florida
Medicine Invention Design, Inc. - IORG0007849 - NPI 1023387701 Rockville Maryland
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05987956 on ClinicalTrials.gov ↗ ← All trials in the USA