Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALECENSA- alectinib · 1 trial · 1 indication
* 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.
* 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.
| Arm | Type | Description |
|---|---|---|
| ALECENSA - alectinib hydrochloride capsule | EXPERIMENTAL | * 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) |
| Name | Type | Description |
|---|---|---|
| ALECENSA - alectinib hydrochloride capsule | DRUG | * 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 |
* 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...