Study of TLK286 (Telcyta) vs. Gefitinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Telik

Status and phase: Completed; Phase 3

Conditions: Non Small Cell Lung Carcinoma

Treatments: Drug: TLK286 (Telcyta) HCl for Injection; Drug: gefitinib (Iressa)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00080340

TLK286.3020

Details and patient eligibility

About

The purpose of this study is to determine if TLK286(Telcyta) is more effective than gefitinib (Iressa) in the treatment of non-small cell lung cancer.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of non-small cell lung cancer
• Non-small cell lung cancer that is not curable with surgery, radiation, or combined modality chemoradiation
• Failed two prior chemotherapy regimens which must have included platinum
• Measurable disease

Exclusion criteria

• Treatment with more than two prior chemotherapy regimens
• History of bone marrow transplantation or stem cell support
• Pregnant or lactating women
• Known history of prior gefitinib therapy
• Known history of prior TLK286 therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)