Non-squamous advanced Non-Small-Cell Lung-Cancer (Stage IV) MedDRA version: 16.0 Level: LLT Classification code 10025077 Term: Lung carcinoma stage IV System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Bevacizumab (Avastin®
Durchstechflasche mit
100mg/4ml )
Product Name: Bevacizumab (Avastin®)
Pharmaceutical Form: Solution for infusion
Trade Name: Bevacizumab (Avastin®
Durchstechflasche mit 400mg/16 ml)
Product Name: Bevacizumab (Avastin®)
Pharmaceutical Form: Solution for infusion
Trade Name: Pemetrexed (ALIMTA 500mg)
Product Name: ALIMTA 500mg
Pharmaceutical Form
Sponsors
Aktion Bronchialkarzinom (ABC) e.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histological confirmed Non-Small-Cell lung cancer 2. Tumor stage IV (UICC 7th Version) 3. The following histological tumor types are eligible: - Adenocarcinoma (including adenocarcinomas with bronchioloalveolar differentiation) - Large Cell carcinoma without neuroendocrine differentiation - Mixed Cell Carcinoma without small cell fraction and without predominant squamous cell fraction - undifferentiated non-small-cell-carcinoma 4. No previous chemotherapy for stage IV NSCLC 5. Adjuvant or neoadjuvant chemotherapy for NSCLC must be completed at least one year prior to study enrolment (from end of chemotherapy) 6. No previous treatment with Pemetrexed or Bevacizumab 7. Patients with prior radiation therapy may be eligible for this study if they meet the following guidelines: - Previous radiation therapy is allowed to 50 ml/min - Urine dipstick for proteinuria =65 years) yes F.1.3.1 Number of subjects for
Exclusion criteria
Exclusion criteria: 1. Histological confirmed predominant squamous cell carcinoma 2. Presence of activating EGFR mutations in exons 18-21 3. Pregnancy or lactation period 4. Have known central nervous system disease, other than stable, treated brain metastasis. Stable, treated brain metastasis is defined as metastasis having no evidence of progression or hemorrhage after treatment and no ongoing requirement for dexamethasone, as ascertained by clinical examination and posttreatment brain imaging. Patients should be off corticosteroids for 1 week at the time of the post-treatment brain CT/MRI. Anticonvulsants are allowed. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician, and must have been completed > 28 days prior to Day 1 of Cycle 1. Patients with CNS metastases treated by neurosurgical resection or brain biopsy performed within 8 weeks prior to Day 1 of Cycle 1 will be excluded 5. Evidence of tumor invading or abutting major blood vessels 6. Presence of a tracheobronchial fistula 7. History of abdominal fistula or fistulisation of urogenital tract, gastrointestinal perforation or intra-abdominal abscess, inflammatory bowel disease, or diverticulitis within 6 months prior to study start 8. Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of a CIS of the cervix, nonmelanomatous skin cancer, stable chronic lymphatic leukaemia, non-muscle invasive bladder cancer or surgically treated or irradiated prostate cancer with no signs of recurrence for one year. Patients with other malignancies curatively treated and free of disease for at least 5 years will be discussed with the Principal Investigator before inclusion 9. Treatment with an investigational new drug, currently or within the last 28 days, and/or participation in another clinical trial, currently or during the last 12 weeks, and/or previous participation in this study. 10. History or presence of a mental disease or condition such as to interfere with the patient's ability to understand the requirements of the study and the intake of study medication according to study protocol. 11. Patients with any clinically significant disease that in the opinion of the investigator is likely to put the patient at risk or to interfere with the evaluation of the patient's safety and of the study outcome. This includes, but is not limited to: - Immediate need for therapeutic intervention - Clinically significant cardiac disease or myocardial infarction within the last 6 months 12. Have a history of hypertension, unless hypertension is well controlled upon study entry and the patient is on a stable regimen of antihypertensive therapy. Patients should not have any prior history of hypertensive crisis or hypertensive encephalopathy. 13. Non healing wound, ulcer or bone fracture 14. Fresh thrombosis under full dose therapy with anticoagulants 15. History of thrombotic disorders within the last 6 months prior to entry 16. Current or recent full-dose oral or parenteral anticoagulants, or thrombolytic agents for therapeutic purposes 17. Prophylactic use of anticoagulants is allowed; international normalized ratio should be 325 mg/day 19. Current or recent use of Plavix/Clopidogrel, at doses >75 mg/d, dipyramidole, ticlopidine, cilostazol 20. Hemorrhagic diathesis, Hemophilia A, Hemophilia B 21. Implantation o
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the activity of a first-line treatment related to Thymidylate Synthetase (TS) Expression in patients with non-squamous advanced Non-Small Cell Lung Cancer. The main efficacy parameter is the progression free survival (PFS).;Secondary Objective: - Overall survival - Quality of life - Response rate - Explorative subgroup analyses (for example: LDH-level, gender, age, performance status, histology, smoking history) - Molecular investigations - Analysis of prognostic and predictive value of TS-Expression;Primary end point(s): Progression free survival (PFS).;Timepoint(s) of evaluation of this end point: PFS will be calculated from the date of start of treatment (cycle 1, day 1) to the date of first progression, death or date of last contact. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Quality of life - Response rate - Explorative subgroup analyses - Molecular investigations;Timepoint(s) of evaluation of this end point: - Screening, day 1, day 84 and end of treatment (quality of life questionnaire) - Total study duration | — |
Countries
Germany
Contacts
Public ContactClinical Operations
Pierrel Research Europe GmbH
Outcome results
None listed