Trial Of CP-751, 871 And Erlotinib In Refractory Lung Cancer

Study ID	NCT00673049
Status	Recruiting
Phase	3
Source	ClinicalTrials.gov

Started	May 1 2008
Last Updated	Feb 2 2010
Estimated Completion	Feb 2 2010

About this clinical study

Summary

The objective of this study is to test a clinical benefit of the addition of CP 751,871 to erlotinib therapy in patients with advanced NSCLC of non adenocarcinoma histology. The primary endpoint is Overall Survival (OS).

Condition / Disease

Carcinoma, Large Cell
Carcinoma, Non-Small-Cell Lung
Carcinoma, Squamous Cell
Carcinoma, Adenosquamous Cell

Therapy

CP 751,871 (Figitumumab) and Erlotinib
Erlotinib

Study Outcomes

Overall Survival
To assess the safety and tolerability of multiple doses of CP 751,871
To assess the efficacy of CP 751,871 in terms of ORR
To monitor for the occurrence of anti drug antibody in response to CP 751,871
To collect PK data of CP 751,871 for population PK meta-analysis
To test for the presence of Circulating Tumor Cells (CTCs) expressing the IGF IR
To assess the differences in health state utilities using the EQ-5D
Progression Free Survival (PFS)

Overview

Gender	male, female

Target Enrollment	600

Recruiting Healthy Volunteers	No

Locations

Pfizer Investigational Site

Washington

Criteria

Inclusion Criteria:

Non small cell lung cancer with a primary histology of squamous cell, large cell or adenosquamous carcinoma. At least 1 measurable lesion, as defined by RECIST.