Clinical trial · Interventional
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.
NCT05987956CI-TRIAL-00123365Drugs-SNPsactive not recruitingPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ALK-Positive Non-Small Cell Lung Cancer (NSCLC) | ALK-Positive Lung Non-Small Cell Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ALECENSA - alectinib hydrochloride capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ALECENSA - alectinib hydrochloride capsule
- description
- * Usual Alectinib Chemotherapy (NDC...01) * ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily * Usual Approach Group (NDC...01) (Patient 1-300) * Study Alectinib Chemotherapy (NDC...86) * ALECENSA - alectinib hydrochloride capsule 600 mg orally twice daily * Study Approach Group (NDC...86) (Patient 301-600)
- interventionNames
- Drug: ALECENSA - alectinib hydrochloride capsule
Primary outcomes (2)
- measure
- Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated
- timeFrame
- Up to 12 weeks
- description
- * 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 24 Years
- Maximum age
- 64 Years
Show eligibility criteria text
* 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
References
Publications (0)
Data not yet available
No reference posted for this study.