Phase III randomized trial of BIBW 2992 plus weekly paclitaxel versus Investigator`s choice of chemotherapy following BIBW 2992 monotherapy in non-small cell lung cancer patients failing previous erlotinib or gefitinib treatment - LuxLung 5

Conditions: patients with Stage IIIb or IV non-small cell lung cancer (NSCLC) after failure of treatment with erlotinib or gefitinib
MedDRA version: 9.1Level: LLTClassification code 10025054
MedDRA version: 9.1Level: LLTClassification code 10029522

Registration Number: EUCTR2009-014563-39-IT

Lead Sponsor: BOEHRINGER ING.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 900

Inclusion Criteria

Part A 1.) Patients with pathologically confirmed diagnosis of NSCLC Stage IIIb (with cytologically proven pleural effusion or pericardial effusion) or Stage IV who have failed treatment with erlotinib (Tarceva) or gefitinib (Iressa). 2.) Patients should have received and failed at least one line of cytotoxic chemotherapy for advanced or metastatic disease; however, the following patient are exempt a.Patients with known EGFR mutation shown by accepted methods are eligible after therapy with reversible TKI without prior chemotherapy; b.Patients with clinical benefit (disease stabilization or ant-tumour response) to erlotinib (Tarceva) or gefitinib (Iressa) for >=6 months are eligible without prior chemotherapy. 3.) Eastern Cooperative Oncology Group (ECOG) performance Score 0-2. 4.) Patients with at least one tumour 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 according to RESIST 1.1. 5.) Male and female patients age >=18 years. 6.) Life expectancy of at least 12 weeks. 7.) Written informed consent that is consistent with ICH-GCP guidelines. Part B 1.)Clinical benefit (disease stabilization or antitumour response) of greater than 12 weeks duration in Part A of the trial. 2.)Patients should have progressed in Part A according to RECIST 1.1. 3.)New informed consent, including consent to biomarker sampling, must be signed before patients enter Part B of the trial.
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

Exclusion Criteria

1)Previous treatment with BIBW 2992; 2)Chemo-, hormone- (other than corticosteroids required for maintenance non-cancer therapy or as premedication before chemotherapy) or immunotherapy within the past 4 weeks; 3)Active brain metastases (stable <4 weeks, symptomatic, or leptomeningeal disease). Dexamethasone therapy will be allowed if administered as a stable dose for at least one month before randomization; 4)Significant or recent acute gastrointestinal disorders with diarrhea as a major symptom e.g., Crohn s disease, mal-absorption, or CTCAE Grade >2 diarrhea of any etiology at baseline; 5) 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; 6) Other malignancies diagnosed (other than non-melanomatous skin cancer and in situ cervical cancer) requiring therapy; 7) Radiotherapy within the past 2 weeks prior to treatment with the trial drug; 8) History or presence of clinically relevant cardiovascular abnormalities such as uncontrolled hypertension, congestive heart failure New York Heart Association (NYHA) functional classification of 3, unstable angina, or poorly controlled arrhythmia. Myocardial infarction within 6 months prior to randomization; 9) Cardiac left ventricular function with resting ejection fraction of less than 50% measured by multigated blood pool imaging of the heart (MUGA scan) or echocardiogram; 10) Prior treatment with anthracyclines with a cumulative dose of doxorubicin (or equivalent) >=400 mg/m**2; 11) Absolute neutrophil count (ANC) <=1500/mm**3; 12) Platelet count <=100,000/mm**3; 13) Bilirubin >=1.5 mg/dL (>26 micromol/L, SI unit equivalent); 14) 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); 15) Serum creatinine >=1.5 times the upper normal limit or calculated/measured creatinine clearance <=45 mL/min; 16) 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; 17) Pregnancy or breast feeding; 18) Patients unable to comply with the protocol; 19) Patients with any serious active infection including known human immunodeficiency virus (HIV), active hepatitis B or active hepatitis C; 20) Known or suspected active drug or alcohol abuse; 21) Pre-existing or current interstitial lung disease (ILD); 22) Peripheral polyneuropathy >Grade 2

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

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