A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone (SUN1058)

Pfizer

Status and phase: Completed; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00265317

A6181058

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: 162 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, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors
• History of or known brain metastases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: sunitinib

Drug: erlotinib

Drug: erlotinib

B

Active Comparator group

Treatment:

Drug: erlotinib

Drug: placebo

Drug: erlotinib