Phase 3 Randomized Study of TLK286 (Telcyta) Versus Gefitinib (Iressa) as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer
Data Collection
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.520 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 339 locations
Department of Veterans Affairs Medical Center
Birmingham, United StatesUniversity of Alabama at Birmingham
Birmingham, United StatesUniversity of Alabama at Birmingham
Birmingham, United States