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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00932893 | An Investigational Drug, PF-02341066 Is Being Studied Versus Standard Of Care In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene | PHASE3 | COMPLETED | 347 | — | — | Sep 1, 2009 | Jan 1, 2016 | Jan 2, 2017 | 264 | United States, Australia +20 |
| NCT00932451 | An Investigational Drug, PF-02341066, Is Being Studied In Patients With Advanced Non-Small Cell Lung Cancer With A Specific Gene Profile Involving The Anaplastic Lymphoma Kinase (ALK) Gene | PHASE2 | COMPLETED | 1,069 | — | — | Jan 1, 2010 | Dec 1, 2015 | Jan 13, 2017 | 280 | United States, Australia +20 |
PFS: Time in months from randomization to first documentation of objective disease progression as determined by independent radiology review or to death due to any cause, whichever occurred first. PFS was calculated as (first event date minus the date of randomization plus 1) divided by 30.4. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria version 1.1 (RECIST v1.1), as at least a 20% increase (including an absolute increase of at least 5 mm) in the sum of diameters of target lesions, taking as reference the smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions.
The objective response rate (ORR) as a measure of anti-tumor efficacy of oral PF-02341066 in participants with advanced NSCLC with an ALK gene translocation or inversion after failure of at least one line of chemotherapy.
Incidence of adverse events and laboratory abnormalities (severity graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\], version 4.0).
| Arm | Type | Description |
|---|---|---|
| PF-02341066 | EXPERIMENTAL | - |
| Pemetrexed or Docetaxel | ACTIVE_COMPARATOR | Investigator selection of either pemetrexed or docetaxel as the active comparator |
| PF-0231066 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| PF-02341066 | DRUG | PF-02341066, 250 mg BID will be administered orally on a continuous schedule |
| Pemetrexed | DRUG | Pemetrexed, 500 mg/m\^2, will be administered by i.v. infusion over 10 minutes on Day 1 of each 21-day cycle |
| Docetaxel | DRUG | Docetaxel, 75 mg/m\^2, will be administered by i.v. infusion over 1 hour on Day 1 of each 21-day cycle |
Inclusion Criteria: * histologically or cytologically proven diagnosis of non-small cell lung cancer * positive for the ALK fusion gene (test provided by a central laboratory) * must have had disease progression after only one prior chemotherapy and that regimen but must have included one platinum ...