A Phase III Trial of Cisplatin/Etoposide/Radiotherapy With Consolidation Docetaxel Followed by Maintenance Therapy With ZD1839 (NSC-715055) or Placebo in Patients With Inoperable Locally Advanced Stage III Non-Small Cell Lung Cancer

NCT00020709 Phase 3 COMPLETED

Randomized phase III trial to compare the effectiveness of combination chemotherapy plus radiation therapy with or without gefitinib in treating unresectable stage III non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of tumors. It is not yet known whether combination chemotherapy plus radiation therapy is more effective with or without gefitinib in treating non-small cell lung cancer

Details

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 3
Status	COMPLETED
Enrolment	840
Start date	2001-06

Conditions

• Adenocarcinoma of the Lung
• Bronchoalveolar Cell Lung Cancer
• Large Cell Lung Cancer
• Squamous Cell Lung Cancer
• Stage IIIA Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer

Interventions

• cisplatin
• docetaxel
• etoposide
• gefitinib
• radiation therapy
• placebo

Primary outcomes

• Overall Survival — From date of registration to date of death due to any cause, assessed up to 10 years
• Progression-free survival — From date of registration to date of first observation of progressive disease, death due to any cause, assessed up to 10 years

Countries

United States