A Randomized Phase III Study of Follow Up With or Without Adjuvant Gefitinib (Iressa™) Following Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer
Data Collection
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Treatment Study
Summary
Study start date: May 1, 2004
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Compare overall survival of patients with stage IIIB or IV non-small cell lung cancer that did not progress on prior first-line palliative induction chemotherapy when treated with adjuvant gefitinib vs placebo. Secondary * Compare progression-free survival of patients treated with these regimens. * Determine the safety and toxicity of gefitinib in these patients. OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients are stratified according to initial disease stage (IIIB vs IV), WHO performance status at the end of prior first-line palliative induction chemotherapy (0-1 vs 2), best patient response to prior first-line palliative induction chemotherapy (objective response vs stable disease), and participating center. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral gefitinib once daily. * Arm II: Patients receive oral placebo once daily. In both arms, treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 598 patients (299 per treatment arm) will be accrued for this study within 8.5 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.598 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
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer meeting 1 of the following stage criteria: * Stage IIIB * Pleural fluid and/or supraclavicular nodes allowed provided patient is not eligible for consolidation radiotherapy * Stage IV disease * No disease progression after 2-6 courses of prior platinum-containing first-line palliative induction chemotherapy * Brain metastases allowed provided patients are asymptomatic after cranial irradiation completed at least 4 weeks ago PATIENT CHARACTERISTICS: Age * 18 and over Performance status * WHO 0-2 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Pulmonary * No history, signs, or symptoms of clinically active interstitial lung disease * Patients with chronic, stable, asymptomatic radiographic changes are eligible Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up * No other malignant disease within the past 5 years except basal cell skin cancer or adequately treated superficial carcinoma of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * Recovered from prior chemotherapy (alopecia allowed) * No concurrent chemotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics Surgery * Not specified Other * No prior epidermal growth factor receptor inhibitors * No concurrent administration of any of the following drugs: * Phenytoin * Carbamazepine * Rifampin * Phenobarbital * Hypericum perforatum (St. John's wort) * No other concurrent anticancer therapy * No other concurrent experimental drugs
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
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 28 locations
Ghent University
Ghent, BelgiumCHR - Clinique Saint Joseph - Hopital de Warqueguies
Mons, BelgiumClinique Sainte Elisabeth
Namur, Belgium