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

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.

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Key information

Conditions

Non Small Cell Lung Carcinoma Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Policlinica Privada Instituto de Medicina Nuclear, Bahía Blanca, Buenos Aires, Argentina

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TLK286 (Telcyta) HCl for Injection

Drug

gefitinib (Iressa)

Drug

Sponsors and collaborators

Lead sponsor

Telik

Industry

Registry information

Official study title

Phase 3 Randomized Study of TLK286 (Telcyta) Versus Gefitinib (Iressa) as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Important dates

Study completion: 2005
First posted: Mar 30, 2004
Registry last updated: Jan 15, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed