IMAC/HerbstA Phase IIIb Randomized, Double-Blind Study Comparing Maintenance ZD1839 (IRESSA®) or Placebo Following Completion of Front Line, Platinum-Based, Double Chemotherapy in Subjects With Advanced or Metastatic Non-Small Cell Lung Cancer
Data Collection
Bronchial Neoplasms+7
+ Carcinoma, Bronchogenic
+ Carcinoma, Non-Small-Cell Lung
Treatment Study
Summary
Study start date: January 1, 2006
Actual date on which the first participant was enrolled.In this Phase IIIb, randomized, double-blind, maintenance study, 300 subjects with advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) (Stage IIIB {T4-pleural effusion} and IV) who have SD or objective tumor response immediately following the completion of 4-6 cycles of front line, platinum-based, doublet chemotherapy will be randomized in a double-blind manner to receive either ZD1839 or placebo.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.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: * Must sign Informed Consent * Females and males aged 18 years and over. * Confirmed stage IIIB (T4-pleural effusion) and IV NSCLC. * Either complete response, partial response, or stable disease following at least 4 cycles (3 in the setting of intolerable toxicity) but no more than 6 cycles of definitive front line, platinum-based, doublet chemotherapy. * No prior EGFR therapy * No newly diagnosed intracerebral metastases while receiving or after completing chemotherapy * At least 3 weeks (21 days) but no more than 4 weeks (28 days) since last dose of chemotherapy * Must be completely healed from previous major oncologic surgery * Life expectancy of ≥ 8 weeks. Exclusion Criteria: * Known severe hypersensitivity to ZD1839 or any of the excipients of these products. * Any evidence of clinically active interstitial lung disease (subjects with chronic, stable, radiographic changes who are asymptomatic need not be excluded). * Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. * Any unresolved chronic toxicity greater than common toxicity criteria (CTC) grade 2 from previous anticancer therapy excluding peripheral neuropathy or alopecia. * Evidence of any significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study. * Pregnancy or breast feeding (women of child bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy. * Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment. * Signs of neurological symptoms consistent with new onset spinal cord compression or CNS metastases. * Treatment with any systemic anticancer therapies other than the prescribed protocol chemotherapy regimen (refer to Inclusion criterion -). Exception: Palliative radiotherapy for symptom relief of lesions present at diagnosis will be allowed; however, this radiotherapy must occur prior to completion of pre-study doublet chemotherapy. * Males must also be willing to practice acceptable methods of birth control while taking the drug to prevent pregnancy of a partner.