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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00080340

Enrollment

520

Registered

2004-03-30

Start date

Unknown

Completion date

2005-05-31

Last updated

2008-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Carcinoma

Brief 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.

Interventions

DRUGTLK286 (Telcyta) HCl for Injection

DRUGgefitinib (Iressa)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

Argentina, Australia, Brazil, Chile, Germany, Italy, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026