Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05987956 | Pharmacogenomics IND EXEMPT SNP Clinical Trial - Alectinib and Single Nucleotide Polymorphisms | PHASE2 | ACTIVE NOT_RECRUITING | 600 | — | — | Mar 18, 2026 | Dec 28, 2026 | Apr 30, 2026 | 2 | United States |
* 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.
| Arm | Type | Description |
|---|---|---|
| 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 |
| 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 |
| Name | Type | Description |
|---|---|---|
| Alectinib - Usual | DRUG | Usual Alectinib Chemotherapy (NDC...01) \- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily |
| Alectinib - Study | DRUG | Study Alectinib Chemotherapy (NDC...86) \- ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily |
* Select 600 Non-Small Cell Lung Cancer Patients who are suitable for blood-drawing. * Dosage Duration at least 90 days * The usual approach group - Recruit 300 double blind random group separated NSCLC patients currently used the Chemotherapy NDC...01 on ALECENSA - alectinib hydrochloride capsule 6...