A PHASE II MULTICENTRE RANDOMISED, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ZD1839 (IRESSA TM) (250MG TABLET) PLUS BEST SUPPORTIVE CARE (BSC) VERSUS PLACEBO PLUS BSC IN CHEMOTHERAPY-NAÏVE PATIENTS WITH ADVANCED (STAGE IIIB OR IV) NON-SMALL CELL LUNG CANCER (NSCLC) AND POOR PERFORMANCE STATUS - INSTEP
- Conditions
- on-Small Cell Lung Cancer
- Registration Number
- EUCTR2004-004206-25-CZ
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1.Provision of written informed consent
2.Male or female, aged 18 years and over
3.Histologically or cytological confirmation of non-small cell lung carcinoma: adenocarcinoma (including bronchoalveolar), squamous cell carcinoma, large cell carcinoma or mixed (adenocarcinoma and squamous) or undifferentiated carcinoma. This may be from the initial diagnosis of NSCLC or subsequent biopsy. Note: sputum cytology alone is not acceptable. Cytological specimens obtained by brushing, washing or needle aspiration of a defined lesion are acceptable
4.NSCLC, locally advanced (Stage IIIB) or metastatic (stage IV) disease, not amenable to curative surgery or radiotherapy
5.Measurable disease according to RECIST criteria with at least one measurable lesion not previously irradiated, unless disease progression has been documented at that site.
6.Ability to provide plasma and urine samples for biomarker analysis
7.WHO performance status (PS) of 2 or 3
8.Not considered suitable for chemotherapy
9.No prior chemotherapy, biological or immunological therapy (including adjuvant and neoadjuvant). Prior surgery and/or localized irradiation is allowed
10.Life expectancy of at least 9 weeks
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Newly diagnosed CNS metastases that have not yet been definitively treated with surgery and/or radiation. Patients with previously diagnosed and treated CNS metastases or spinal cord compression may be considered if they have evidence of clinically stable disease (off steroids or in presence of a tailing steroid dose) for at least 4 weeks
2.Less than 4 weeks since completion of prior radiotherapy or persistence of any radiotherapy related toxicity.
3.Known severe hypersensitivity to ZD1839 or any of the excipients of this product
4.Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
5.Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy (except alopecia)
6.As judged by the investigator, any evidence of severe or uncontrolled systemic disease (e.g., unstable or uncompensated respiratory, cardiac, hepatic, or renal disease)
7.Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than
5 times the upper limit of the reference range (ULRR)
8.Absolute neutrophil counts (ANC) less than 1.0 x 109/L or platelets less than
100 x 109/L
9.Serum bilirubin greater than 3 times the upper limit of the reference range (ULRR)
10.Any evidence of clinically active interstitial lung disease (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded)
11.Evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study
12.Pregnancy or breastfeeding (women of child-bearing potential). Women of childbearing potential must practice acceptable methods of birth control to prevent pregnancy
13.Concomitant use of phenytoin, carbamazepine, rifampicin, barbiturates, or St John’s Wort
14.Prior treatment with EGFR inhibitors
15.Treatment with a non-approved or investigational drug within 30 days before
Day 1 of study treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare ZD1839 + best supportive care (BSC) versus placebo + BSC in terms of progression-free survival;Secondary Objective: 1. To compare ZD1839 + BSC versus placebo + BSC in terms of overall objective tumour response rate (complete response [CR] and partial response [PR])<br>2. To compare ZD1839 + BSC versus placebo + BSC in terms of overall survival<br>3. To compare ZD1839 + BSC versus placebo + BSC in terms of pulmonary symptom improvement<br>4. To compare ZD1839 + BSC versus placebo + BSC in terms of quality of life<br>5. To compare ZD1839 + BSC versus placebo + BSC in terms of tolerability<br>;Primary end point(s): Progression-free survival
- Secondary Outcome Measures
Name Time Method