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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01154140 | A Clinical Trial Testing The Efficacy Of Crizotinib Versus Standard Chemotherapy Pemetrexed Plus Cisplatin Or Carboplatin In Patients With ALK Positive Non Squamous Cancer Of The Lung | PHASE3 | COMPLETED | 343 | — | — | Jan 13, 2011 | Nov 30, 2016 | Nov 6, 2017 | 249 | United States, Australia +29 |
PFS was defined as the time from the date of randomization in study until the date of first documented objective tumor progression (according to RECIST v1.1 as determined by IRR) or death (due to any cause), whichever occurred first. PFS (in months) was calculated as (first event date - randomization date +1)/30.44. Objective progression was defined as a 20 percent (%) increase in the sum of the diameters of target measurable lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study), with a minimum absolute increase of 5 millimeter (mm) or clear progression of pre-existing non-target lesions, or the appearance of any new clear lesions.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | - |
| B | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| treatment | DRUG | crizotinib 250mg orally continuous twice daily dosing |
Inclusion Criteria: * Proven diagnosis of locally advanced not suitable for local treatment, recurrent and metastatic non-squamous cell carcinoma of the lung * Positive for translocation or inversion events involving the ALK gene locus * No prior systemic treatment for locally advanced or metastati...