Phase IIb/III randomized, double-blind trial of BIBW 2992 plus bestsupportive care (BSC) versus placebo plus BSC in non small cell lungcancer patients failing erlotinib or gefitinib - Phase IIb/III NSCLC Iressa/Tarceva Failures
- Conditions
- Patients with confirmed diagnosis of non-small cell lung cancer whose disease progressed after at least one but not more than two lines of cytotoxic chemotherapy of which one must have been a platinum containing regimen with erlotinib or gefitinib for at least 12 weeks.
- Registration Number
- EUCTR2007-005983-28-DE
- Lead Sponsor
- Boehringer Ingelheim Pharma GmbH & Co.KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 560
1) Patients with pathological confirmation of non-small cell lung cancer stage III-B (with pleural effusion) adenocarcinoma or stage IV adenocarcinoma who have failed at least one but not more than two lines of cytotoxic chemotherapy (including adjuvant chemotherapy). One of the chemotherapy regimens must have been platinum based.
2) Progressive disease following at least 12 weeks of treatment with erlotinib (Tarceva®) or gefitinib (Iressa®)
3) Eastern Cooperative Oncology Group (ECOG) performance Score 0, 1 or 2.
4) Patients with at least one tumor lesion that can accurately be measured by magnetic resonance imaging (MRI), or computed tomography (CT) in at least one dimension with longest diameter to be recorded as =20 mm using conventional techniques or =10 mm with spiral CT scan
5) Male and female patients age =18 years
6) Life expectancy of at least three (3) months
7) Written informed consent that is consistent with ICH-GCP guidelines
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) More than two prior cytotoxic chemotherapy treatment regimens for relapsed or metastatic non-small cell lung cancer
2) Use of erlotinib or gefitinib within 14 days of treatment Day 1
3) Chemo-, hormone-, (other than megestrol acetate or steroids required for maintenance non-cancer therapy) or immunotherapy within the past 4 weeks
4) Active brain metastases (stable <4weeks, symptomatic, requiring treatment with anticonvulsants, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization
5) Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g. Crohn's disease, malabsorption, or CTCAE Grade>2 diarrhea of any etiology at baseline
6) Patients who have any other life threatening illness or organ system dysfunction, which in the opinion of the investigator, would either compromise patient safety or interfere with the evaluation of the safety of the test drug
7) Other malignancies diagnosed within the past five years (other than non-melanomatous skin cancer and in situ cervical cancer)
8) Radiotherapy with the past 2 weeks prior to treatment with the trial drug
9)History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia including New York Heart Association (NYHA) functional classification of 3
10) Cardiac left ventricular function with resting ejection fraction of less than 50% measured by MUGA scan or echocardiogram
11) QTc interval =0.47 second
12) Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) =400 mg/m2
13) Absolute neutrophil count (ANC) less than 1500 / mm3
14) Platelet count =100,000 / mm3
15) Bilirubin =1.5 mg / dl (>26 micromol / L, SI unit equivalent)
16) Aspartate amino transferase (AST) or alanine amino transferase (ALT) = three times the upper limit of normal (if related to liver metastases = five times the upper limit of normal)
17) Serum creatinine = 1.5 times of the upper normal limit or calculated/measured creatine clearance =45ml/min
18) Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the trial
19) Pregnancy or breast feeding
20) Patients unable to comply with the protocol
21) Patients with any serious active infection including known HIV, active hepatitis B or active hepatitis C
22) Known or suspected active drug or alcohol abuse
23) Patient with known Interstitial Lung Disease (ILD)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method