patients with advanced or metastatic non small cell lung cancer (NSCLC) stage IIIB or IV who relapsed after or failed first-line chemotherapy
Conditions
Sponsors
Boehringer Ingelheim Pharma GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.) male or female patient aged 18 years or older 2.) patient with histologically or cytologically confirmed advanced or metastatic NSCLC of stage IIIB or IV 3.) patient who has relapsed or failed prior first-line chemotherapy for advanced or metastatic disease 4.) patient 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 (longest diameter to be recorded) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral CT scan 5.) life expectancy of at least three months 6.) Eastern co-operative oncology group (ECOG) performance score of 2 or less 7.) patient must have given written informed consent which must be consistent with international conference on harmonisation – good clinical practice (ICH-GCP) and local legislation 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
Exclusion criteria: 1.) hypersensitivity to the trial drug or the excipients 2.) persistence of toxicities of prior anti cancer therapies which are deemed to be clinically relevant 3.) known secondary malignancy requiring therapy 4.) brain metastases which are symptomatic or require therapy 5.) absolute neutrophil count less than 1,500/mm3 6.) platelet count less than 100,000/mm3 7.) haemoglobin less than 9 mg/dl 8.) aspartate amino transferase (AST) or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal, or AST or ALT greater than 5 times the upper limit of normal in case of known liver metastases 9.) bilirubin greater than 1.5 mg/dl (> 26 micromol/l, SI unit equivalent) 10.) serum creatinine greater than 2.0 mg/dl 11.) concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug 12.) chemo-, hormone- or immunotherapy within the past four weeks or within less than four half-life times of the previous drug prior to treatment with the trial drug (whatever is the longest period) 13.) radiotherapy within the past four weeks prior to treatment with the trial drug 14.) men or women who are sexually active and unwilling to use a medically acceptable method of contraception during the trial 15.) pregnancy or lactation 16.) treatment with any other investigational drug within the past four weeks or within less than four half-life times of the investigational drug before treatment with the trial drug (whatever is the longest period) 17.) patient unable to comply with the protocol 18 ) patients who are considered eligible by the investigator for other second-line chemotherapy, radiotherapy or immunotherapy will not be included in the trial 19) patients who have received more than two lines of prior anti-tumour therapy for advanced or metastatic non small cell lung cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: objective tumour response evaluated according to the RECIST criteria (The present trial will be performed to evaluate whether BI 2536 may be effective in the treatment of advanced or metastatic NSCLC of stage IIIB or IV in patients who relapsed after or failed first-line therapy. A secondary aim is to identify the most suitable dosage schedule for the further Phase II and III clinical programme of BI 2536. To achieve this objective two dosage schedules are compared. A single dose of 200 mg BI 2536 administered on day one of a treatment course will be compared with 50 mg BI 2536 administered on days one, two and three of a treatment course. Furthermore, an assessment is planned to be made whether an intraindividual dose escalation is feasible.);Secondary Objective: 1.) progression free survival 2.) overall survival 3.) duration of overall response 4.) clinical tumour assessment 5.) quality of life assessment 6.) BI 2536 plasma concentrations 7.) incidence and intensity of adverse events graded according to CTCAE 8.) incidence of dose limiting toxicity 9.) laboratory investigations 10.) vital signs ;Primary end point(s): objective tumour response evaluated according to the RECIST criteria | — |
Countries
Germany
Outcome results
None listed