Trial Of Erlotinib With Or Without PF-3512676 In Advanced Non Small Cell Lung Cancer

Phase 2

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: PF-3512676 + Erlotinib; Drug: Erlotinib

• Registration Number: NCT00321815
• Lead Sponsor: Pfizer

Brief Summary

To assess the efficacy and safety of PF-3512676 administered in combination with erlotinib in patients with advanced EGFR-positive non-small cell lung cancer after failure of at least one prior chemotherapy regimen.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-05-03
• Study First Submitted QC: 2006-05-03
• Study First Posted: 2006-05-04
• Study Start: 2006-08
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Disposition First Submitted: 2010-08-09
• Disposition First Submitted QC: 2010-08-09
• Disposition First Posted: 2010-08-11
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-16
• Last Update Posted: 2010-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	PF-3512676 + Erlotinib	Standard of Care chemotherapy plus experimental intervention (PF-3512676)
B	Erlotinib	Standard of Care chemotherapy

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival	50Events

Secondary Outcome Measures

Name	Time	Method
Overall Safety Profile	28 days post treatment
Time to Tumor Progression	End of treatment
Overall Objective Response Rate	Time of disease progression
Duration of Response	Time of disease progression
Overall Survival	Time of death

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Dalls, Texas, United States