Advanced or recurrent non-squamous non-small cell lung cancer MedDRA version: 9 Level: PT Classification code 10059515
Conditions
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients included in the study should have the following criteria: 1. Written informed consent (informed consent document to be approved by the institution’s Independent Ethics Committee and patient consent obtained prior to any study-specific procedure) 2. Age =18 years 3. Able to comply with the protocol 4. Histologically or cytologically documented inoperable, locally advanced (Stage IIIb with supraclavicular lymph node metastases or malignant pleural or pericardial effusion), metastatic (Stage IV) or recurrent NSCLC other than squamous cell (tumours of mixed histology should be categorized by the predominant cell type) 5. ECOG PS 0-2 6. Life expectancy =12 weeks 7. Adequate haematological function - Absolute neutrophil count (ANC) =1.5 x 10[9]/L AND - Platelet count =100 x 10[9]/L AND - Haemoglobin =9 g/dL (may be transfused to maintain or exceed this level) 8. Adequate liver function - Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with any of the following will be excluded from study entry: 1. Mixed, non-small cell and small cell tumours or mixed adenosquamous carcinomas with a predominant squamous component 2. History of haemoptysis, defined as bright red blood of at least half a teaspoon in the 3 months prior to enrolment 3. Evidence of tumour invading major blood vessels on imaging. The investigator or the local radiologist must exclude evidence of tumour that is fully contiguous with, surrounding, or extending into the lumen of a major blood vessel (e.g. pulmonary artery or superior vena cava) 4. Evidence of CNS metastases, even if previously treated. If suspected, the patient should be scanned within 28 days prior to enrolment to rule out CNS metastases 5. Neoadjuvant/adjuvant chemotherapy within 6 months prior to enrolment 6. Radiotherapy within 28 days prior to enrolment 7. Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment or anticipation of the need for major surgery during study treatment 8. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion 9. Current or recent use of aspirin (>325 mg/day) 10. Current or recent (within 10 days of first dose of bevacizumab) use of full-dose oral or parenteral anticoagulants or thrombolytic agent for therapeutic purposes. Prophylactic use of anticoagulants is allowed 11. History of evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding 12. Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg) 13. Clinically significant (i.e. active) cardiovascular disease for example CVA (=6 months before enrolment), myocardial infarction (=6 months before enrolment), unstable angina, CHF NYHA Class =II, serious cardiac arrhythmia requiring medication during the study and might interfere with regularity of the study treatment, or not controlled by medication 14. Non-healing wound, active peptic ulcer or bone fracture 15. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment 16. Women with an intact uterus (unless amenorrhoeic for the last 24 months) not using effective, non-hormonal means of contraception (intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile). Men who do not agree to use effective contraception during the study and for a period of 60 days following the last administration of bevacizumab 17. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment 18. Known hypersensitivity to bevacizumab and any of its excipients, and any of the chemotherapies 19. Evidence of any other disease, neurological or metabolic dysfunction, physical examination finding or laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or puts the patient at high risk for treatment-related complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety profile of bevacizumab when combined with standard chemotherapy as first-line treatment of advanced or recurrent non-squamous NSCLC. In particular, the incidence of serious adverse events (SAEs) related to bevacizumab and the incidence of specific AEs (serious and non-serious) such as hypertension, proteinuria, wound healing complications, gastrointestinal perforations, arterial and venous thomboembolic events, haemoptysis, CNS bleeding, other haemorrhages and CHF will be investigated.;Secondary Objective: To assess the efficacy of bevacizumab as measured by TTP and OS. To assess the safety of bevacizumab in patients who develop CNS metastases during the treatment period. ;Primary end point(s): The incidence of SAEs related to bevacizumab and the incidence of specific AEs (serious and non-serious) such as hypertension, proteinuria, wound healing complications, arterial and venous thomboembolic events, haemoptysis, CNS bleeding, other haemorrhages, gastrointestinal perforations and CHF, are considered as primary endpoints. (ECOG PS 2 patients will be analysed separately.) | — |
Countries
Austria, Czech Republic, Denmark, Estonia, Finland, Germany, Hungary, Iceland, Italy, Latvia, Lithuania, Netherlands, Portugal, Slovenia, Spain, Sweden, United Kingdom
Outcome results
None listed