Overview

Study Of The Effect Of CP-751,871 In Combination With Gemcitabine And Cisplatin In Patients With Advanced Non-Small Cell Lung Cancer

Status:
Withdrawn

Trial end date:
2014-05-01

Target enrollment:
0

Participant gender:
All

Summary

Gemcitabine and cisplatin given together is a standard treatment option for advanced lung cancer patients. The purpose of this study is to assess if the life span is longer in patients taking the investigational drug CP-751,871 in combination with gemcitabine and cisplatin compared to gemcitabine and cisplatin alone. Considering a 10% rate of drop-outs, 1,210 participants will be required in order to have an adequate sample size (1,100 evaluable patients) and power to detect a 30% prolongation of survival on the experimental arm.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Pfizer

Treatments:

Antibodies, Monoclonal
Cisplatin
Gemcitabine

Criteria

Inclusion Criteria:

- Non-Small Cell Lung Cancer (NSCLC), advanced, chemotherapy-naive

- Male or female > 18 years

- Eastern Oncology Cooperative Group (ECOG) Performance Status (PS) 0 or 1

- Adequate organ function

Exclusion Criteria:

- Uncontrolled hypertension or diabetes;

- Pregnant female;

- Symptomatic Central Nervous System (CNS) metastasis, requirement for chronic
corticosteroids.