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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01360554 | ARCHER 1009 : A Study Of Dacomitinib (PF-00299804) Vs. Erlotinib In The Treatment Of Advanced Non-Small Cell Lung Cancer | PHASE3 | COMPLETED | 878 | — | — | Jun 16, 2011 | Sep 14, 2015 | May 24, 2017 | 224 | United States, Austria +21 |
| NCT01858389 | A Study Of Dacomitinib (PF-00299804) In Patients With Advanced Non-Small Cell Lung Cancer | PHASE2 | COMPLETED | 41 | — | — | Jul 1, 2013 | Sep 1, 2015 | Jul 18, 2017 | 14 | United States, South Korea |
PFS was defined as the time from randomization to the date of disease progression as by Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions.
PFS was defined as the time from randomization to the date of disease progression as by RECIST v1.1 per Independent Radiologic Review or death due to any cause, whichever occurred first. Objective progression was defined as a 20% increase in the sum of the diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum is observed during therapy), with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions, or the appearance of any new unequivocal malignant lesions. Tumor tissue from participants' original diagnostic biopsies or recently obtained biopsies were analyzed to determine KRAS status.
BOR was best response from start of treatment until disease progression, according to the RECIST,v1.1. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis \<10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. Progression= ≥20% increase in the sum of diameters of target measurable lesions above the smallest sum observed, with a minimum absolute increase of 5 mm or unequivocal progression of pre-existing non-target lesions or appearance of any new unequivocal malignant lesions. Stable disease=not qualify for CR, PR or progression. BOR was analyzed only for participants with T790M mutation according to the primary study objective.
ORR was calculated as the percentage of participants with a confirmed CR or PR relative to the total number of participants enrolled. Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.1 were used to define CR and PR. CR=disappearance of all preexisting lesions except nodal disease, with all nodal lesions decreased to normal size (short axis \<10 mm) and no appearance of new unequivocal malignant lesions. PR= ≥30% decrease from baseline of sum of diameters of all target lesions with no unequivocal progression of preexisting non-target lesions or appearance of new lesions. CR and PR were confirmed on a follow-up imaging assessment ≥4 weeks after the initial response documentation. ORR was analyzed only for participants with T790M mutation according to the primary study objective.
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | Blinded active PF-00299804 + blinded placebo comparator (erlotinib) |
| B | ACTIVE_COMPARATOR | Blinded active comparator (erlotinib) + blinded placebo PF-00299804 |
| Cohort A | EXPERIMENTAL | Patients with NSCLC whose tumor has a documented T790M mutation in exon 20 of the Epidermal Growth Factor Receptor. |
| Cohort B | EXPERIMENTAL | Patients with NSCLC. No requirement of a specific molecular signature, but excluding known T790M mutations. |
| Name | Type | Description |
|---|---|---|
| Dacomitinib (PF-00299804) | DRUG | Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing |
| Active Comparator (erlotinib) | DRUG | Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing |
| Placebo erlotinib | DRUG | placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing. |
| Placebo PF00299804 | DRUG | placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing |
| Dacomitinib | DRUG | Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter. The dose of dacomitinib for patients in Cohort A may be further escalated in increments of 15 mg. |
Inclusion Criteria: * Evidence of pathologically confirmed, advanced NSCLC (with known histology). * Prior treatment with at least one and no more than two systemic therapy regimens (at least one must be standard chemotherapy for advanced NSCLC). * Adequate tissue sample must be submitted prior to ...