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PF-3512676 + Erlotinib

Phase 2

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Dec 23, 2010

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment43
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00321815Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung CancerPHASE2 COMPLETED 43Aug 1, 2006Jun 1, 2010Dec 23, 201035 United States
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Study Endpoints
Primary Endpoints
Progression-Free Survival
50Events
Secondary Endpoints
Overall Safety Profile
28 days post treatment
Time to Tumor Progression
End of treatment
Overall Objective Response Rate
Time of disease progression
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AEXPERIMENTALStandard of Care chemotherapy plus experimental intervention (PF-3512676)
BACTIVE_COMPARATORStandard of Care chemotherapy
Interventions
NameTypeDescription
PF-3512676 + ErlotinibDRUGPF-3512676 0.2 mg/kg subcutaneously on days 1, 8 and 15 of each 21 day cycle until disease progression or unacceptable toxicity. Erlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
ErlotinibDRUGErlotinib 150 mg orally daily (21 day cycles) until disease progression or unacceptable toxicity
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites35

Inclusion Criteria: * Advanced, EGFR-positive NSCLC * ECOG Performance Status 0, 1 or 2 * Measurable disease Exclusion Criteria: * Known CNS metastasis * Pre-existing autoimmune or antibody mediated disease

Countries:United States
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