A Study In Patients With Non-Small Cell Lung Cancer To Test If Erlotinib Plus SU011248 Is Better Than Erlotinib Alone

Pfizer

Status and phase: Completed; Phase 3

Conditions: Carcinoma, Non-Small Cell Lung

Treatments: Drug: placebo; Drug: erlotinib; Drug: sunitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00457392

SUN1087

A6181087

Details and patient eligibility

About

This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen.

Enrollment: 960 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with locally advanced/metastatic non-small cell lung cancer
• Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

Exclusion criteria

• Prior treatment with any receptor tyrosine kinase inhibitors, VEGF inhibitor (with the exception of bevacizumab) or other angiogenesis inhibitors
• History of or known brain metastases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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960 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: erlotinib

Drug: erlotinib

Drug: sunitinib

2

Active Comparator group

Treatment:

Drug: placebo

Drug: erlotinib

Drug: erlotinib